<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT02993302</url>
  </required_header>
  <id_info>
    <org_study_id>RSCM/FKUI</org_study_id>
    <nct_id>NCT02993302</nct_id>
  </id_info>
  <brief_title>Effects Of Oral Alfacalcidol On Maturation Of Dendritic Cells In Graves' Disease Patients</brief_title>
  <official_title>Effects Of Oral Alfacalcidol On Maturation Of Dendritic Cells In Graves' Disease Patients</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Dr Cipto Mangunkusumo General Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Indonesia University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Dr Cipto Mangunkusumo General Hospital</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Maturity level of dendritic cells (DC) plays a pivotal role in initiating and regulating&#xD;
      autoimmunity. In Graves' disease (GD), DCs have more active immune responses than those in&#xD;
      healthy subjects. Our previous study demonstrated immunoregulatory effects of in vitro&#xD;
      1,25-D3 on maturation of DC in GD patients. This study aims to evaluate the effect of oral&#xD;
      1α-D3 on DC maturation in GD patients.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Patients with Graves' disease were divided into two groups: groups receiving oral 1α-D3 in&#xD;
      addition to propylthiouracil (PTU) and groups receiving placebos in addition to PTU.&#xD;
      Comparison of DC maturation were performed before and after the oral 1α-D3. DC maturation was&#xD;
      assessed based on the expression of DC markers (HLA-DR, CD80, CD40, CD83, CD14 and CD206) and&#xD;
      the ratio of cytokines interleukin-12/IL-10.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>July 2014</start_date>
  <completion_date type="Actual">March 2015</completion_date>
  <primary_completion_date type="Actual">March 2015</primary_completion_date>
  <phase>Phase 2</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Double (Participant, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>CD80 Level</measure>
    <time_frame>1 year</time_frame>
    <description>Dendritic cells maturation levels were measured by the CD80 (cluster of differentiation 80)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>CD206 Level</measure>
    <time_frame>1 year</time_frame>
    <description>Dendritic cells maturation levels were measured by the CD206</description>
  </primary_outcome>
  <primary_outcome>
    <measure>IL-12/IL-10 Ratio</measure>
    <time_frame>1 year</time_frame>
    <description>Dendritic cells maturation levels were measured by the IL-12 (interleukin-12)/IL-10 ratio</description>
  </primary_outcome>
  <primary_outcome>
    <measure>fT4 Levels</measure>
    <time_frame>1 year</time_frame>
    <description>fT4 (free thyroxine)</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">25</enrollment>
  <condition>Graves Disease</condition>
  <arm_group>
    <arm_group_label>PTU-Oral 1α-D3</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>patients were given oral 1α-D3 at dose of 1.5 mcg once daily for 8 weeks in addition to propylthiouracil (PTU) 300 mg daily for 8 weeks as the treatment for Graves' disease with thyrotoxicosis</description>
  </arm_group>
  <arm_group>
    <arm_group_label>PTU-Placebos</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>patients were given placebo tablets for 8 weeks in addition topropylthiouracil (PTU) 300 mg daily for 8 weeks as the treatment for Graves' disease with thyrotoxicosis</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>1α-D3</intervention_name>
    <description>patients were given PTU and 1α-D3</description>
    <arm_group_label>PTU-Oral 1α-D3</arm_group_label>
    <other_name>1α 25-dihydroxyvitamin d3</other_name>
    <other_name>alfacalcidol</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebos</intervention_name>
    <description>patients were given PTU and placebos</description>
    <arm_group_label>PTU-Placebos</arm_group_label>
    <other_name>placebo</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients with Graves' disease and still have not gone into remission&#xD;
&#xD;
          -  Willing to participate in the research&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Pregnant patient&#xD;
&#xD;
          -  Suffered from severe liver disease&#xD;
&#xD;
          -  Suffered from severe kidney disease&#xD;
&#xD;
          -  Taking vitamin D substitution therapy&#xD;
&#xD;
          -  Suffered from another autoimmune disease&#xD;
&#xD;
          -  Suffered from malignancy&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Dyah Purnamasari, M.D., Ph.D</last_name>
    <role>Principal Investigator</role>
    <affiliation>Fakultas Kedokteran Universitas Indonesia</affiliation>
  </overall_official>
  <reference>
    <citation>Tamura M, Matsuura B, Miyauchi S, Onji M. Dendritic cells produce interleukin-12 in hyperthyroid mice. Eur J Endocrinol. 1999 Dec;141(6):625-9. doi: 10.1530/eje.0.1410625.</citation>
    <PMID>10601966</PMID>
  </reference>
  <reference>
    <citation>Banchereau J, Steinman RM. Dendritic cells and the control of immunity. Nature. 1998 Mar 19;392(6673):245-52. doi: 10.1038/32588.</citation>
    <PMID>9521319</PMID>
  </reference>
  <reference>
    <citation>Liang S, Ristich V, Arase H, Dausset J, Carosella ED, Horuzsko A. Modulation of dendritic cell differentiation by HLA-G and ILT4 requires the IL-6--STAT3 signaling pathway. Proc Natl Acad Sci U S A. 2008 Jun 17;105(24):8357-62. doi: 10.1073/pnas.0803341105. Epub 2008 Jun 11.</citation>
    <PMID>18550825</PMID>
  </reference>
  <reference>
    <citation>Inoue N, Watanabe M, Morita M, Tatusmi K, Hidaka Y, Akamizu T, Iwatani Y. Association of functional polymorphisms in promoter regions of IL5, IL6 and IL13 genes with development and prognosis of autoimmune thyroid diseases. Clin Exp Immunol. 2011 Mar;163(3):318-23. doi: 10.1111/j.1365-2249.2010.04306.x. Epub 2011 Jan 14.</citation>
    <PMID>21235536</PMID>
  </reference>
  <reference>
    <citation>Khalilzadeh O, Anvari M, Esteghamati A, Momen-Heravi F, Mahmoudi M, Rashidi A, Amiri HM, Ranjbar M, Tabataba-Vakili S, Amirzargar A. The interleukin-1 family gene polymorphisms and Graves' disease. Ann Endocrinol (Paris). 2010 Sep;71(4):281-5. doi: 10.1016/j.ando.2010.01.005. Epub 2010 Apr 18.</citation>
    <PMID>20400062</PMID>
  </reference>
  <reference>
    <citation>Croizet K, Rabilloud R, Kostrouch Z, Nicolas JF, Rousset B. Culture of dendritic cells from a nonlymphoid organ, the thyroid gland: evidence for TNFalpha-dependent phenotypic changes of thyroid-derived dendritic cells. Lab Invest. 2000 Aug;80(8):1215-25. doi: 10.1038/labinvest.3780129.</citation>
    <PMID>10950112</PMID>
  </reference>
  <reference>
    <citation>Dedecjus M, Stasiolek M, Brzezinski J, Selmaj K, Lewinski A. Thyroid hormones influence human dendritic cells' phenotype, function, and subsets distribution. Thyroid. 2011 May;21(5):533-40. doi: 10.1089/thy.2010.0183. Epub 2010 Dec 29.</citation>
    <PMID>21190445</PMID>
  </reference>
  <reference>
    <citation>Hughes GC, Clark EA. Regulation of dendritic cells by female sex steroids: relevance to immunity and autoimmunity. Autoimmunity. 2007 Sep;40(6):470-81. doi: 10.1080/08916930701464764.</citation>
    <PMID>17729041</PMID>
  </reference>
  <reference>
    <citation>Duperrier K, Farre A, Bienvenu J, Bleyzac N, Bernaud J, Gebuhrer L, Rigal D, Eljaafari A. Cyclosporin A inhibits dendritic cell maturation promoted by TNF-alpha or LPS but not by double-stranded RNA or CD40L. J Leukoc Biol. 2002 Nov;72(5):953-61.</citation>
    <PMID>12429717</PMID>
  </reference>
  <reference>
    <citation>Berer A, Stockl J, Majdic O, Wagner T, Kollars M, Lechner K, Geissler K, Oehler L. 1,25-Dihydroxyvitamin D(3) inhibits dendritic cell differentiation and maturation in vitro. Exp Hematol. 2000 May;28(5):575-83. doi: 10.1016/s0301-472x(00)00143-0.</citation>
    <PMID>10812248</PMID>
  </reference>
  <reference>
    <citation>Wahono CS, Rusmini H, Soelistyoningsih D, Hakim R, Handono K, Endharti AT, Kalim H, Widjajanto E. Effects of 1,25(OH)2D3 in immune response regulation of systemic lupus erithematosus (SLE) patient with hypovitamin D. Int J Clin Exp Med. 2014 Jan 15;7(1):22-31. eCollection 2014.</citation>
    <PMID>24482685</PMID>
  </reference>
  <reference>
    <citation>Bartels LE, Jorgensen SP, Bendix M, Hvas CL, Agnholt J, Agger R, Dahlerup JF. 25-Hydroxy vitamin D3 modulates dendritic cell phenotype and function in Crohn's disease. Inflammopharmacology. 2013 Apr;21(2):177-86. doi: 10.1007/s10787-012-0168-y. Epub 2013 Jan 23.</citation>
    <PMID>23341164</PMID>
  </reference>
  <reference>
    <citation>Agmon-Levin N, Theodor E, Segal RM, Shoenfeld Y. Vitamin D in systemic and organ-specific autoimmune diseases. Clin Rev Allergy Immunol. 2013 Oct;45(2):256-66. doi: 10.1007/s12016-012-8342-y.</citation>
    <PMID>23238772</PMID>
  </reference>
  <reference>
    <citation>Zhou H, Xu C, Gu M. Vitamin D receptor (VDR) gene polymorphisms and Graves' disease: a meta-analysis. Clin Endocrinol (Oxf). 2009 Jun;70(6):938-45. doi: 10.1111/j.1365-2265.2008.03413.x. Epub 2008 Sep 8.</citation>
    <PMID>18782354</PMID>
  </reference>
  <reference>
    <citation>Budiyati AD, Setiyono A, Tarigan E and Wibowo H. The effect of alpha fetoprotein on NF-kB translocation in lipopolysaccharide induced monocyte-derived dendritic cell. Med J Indones. 2012; 21.</citation>
  </reference>
  <reference>
    <citation>Hewison M. Vitamin D and the immune system: new perspectives on an old theme. Endocrinol Metab Clin North Am. 2010 Jun;39(2):365-79, table of contents. doi: 10.1016/j.ecl.2010.02.010.</citation>
    <PMID>20511058</PMID>
  </reference>
  <reference>
    <citation>Antico A, Tampoia M, Tozzoli R, Bizzaro N. Can supplementation with vitamin D reduce the risk or modify the course of autoimmune diseases? A systematic review of the literature. Autoimmun Rev. 2012 Dec;12(2):127-36. doi: 10.1016/j.autrev.2012.07.007. Epub 2012 Jul 7.</citation>
    <PMID>22776787</PMID>
  </reference>
  <reference>
    <citation>Hunt PJ, Marshall SE, Weetman AP, Bell JI, Wass JA, Welsh KI. Cytokine gene polymorphisms in autoimmune thyroid disease. J Clin Endocrinol Metab. 2000 May;85(5):1984-8. doi: 10.1210/jcem.85.5.6588.</citation>
    <PMID>10843185</PMID>
  </reference>
  <results_reference>
    <citation>Bartels LE, Bendix M, Hvas CL, Jorgensen SP, Agnholt J, Agger R, Dahlerup JF. Oral vitamin D3 supplementation reduces monocyte-derived dendritic cell maturation and cytokine production in Crohn's disease patients. Inflammopharmacology. 2014 Apr;22(2):95-103. doi: 10.1007/s10787-013-0197-1. Epub 2013 Dec 29.</citation>
    <PMID>24374976</PMID>
  </results_reference>
  <results_reference>
    <citation>Bartosik-Psujek H, Tabarkiewicz J, Pocinska K, Stelmasiak Z, Rolinski J. Immunomodulatory effects of vitamin D on monocyte-derived dendritic cells in multiple sclerosis. Mult Scler. 2010 Dec;16(12):1513-6. doi: 10.1177/1352458510379611. Epub 2010 Aug 25.</citation>
    <PMID>20739336</PMID>
  </results_reference>
  <results_reference>
    <citation>Abou-Raya A, Abou-Raya S, Helmii M. The effect of vitamin D supplementation on inflammatory and hemostatic markers and disease activity in patients with systemic lupus erythematosus: a randomized placebo-controlled trial. J Rheumatol. 2013 Mar;40(3):265-72. doi: 10.3899/jrheum.111594. Epub 2012 Dec 1.</citation>
    <PMID>23204220</PMID>
  </results_reference>
  <results_reference>
    <citation>Pani MA, Regulla K, Segni M, Hofmann S, Hufner M, Pasquino AM, Usadel KH, Badenhoop K. A polymorphism within the vitamin D-binding protein gene is associated with Graves' disease but not with Hashimoto's thyroiditis. J Clin Endocrinol Metab. 2002 Jun;87(6):2564-7. doi: 10.1210/jcem.87.6.8562.</citation>
    <PMID>12050214</PMID>
  </results_reference>
  <results_reference>
    <citation>Yasuda T, Okamoto Y, Hamada N, Miyashita K, Takahara M, Sakamoto F, Miyatsuka T, Kitamura T, Katakami N, Kawamori D, Otsuki M, Matsuoka TA, Kaneto H, Shimomura I. Serum vitamin D levels are decreased in patients without remission of Graves' disease. Endocrine. 2013 Feb;43(1):230-2. doi: 10.1007/s12020-012-9789-6. Epub 2012 Sep 15. No abstract available.</citation>
    <PMID>22983830</PMID>
  </results_reference>
  <results_reference>
    <citation>Kawakami-Tani T, Fukawa E, Tanaka H, Abe Y, Makino I. Effect of 1 alpha-hydroxyvitamin D3 on serum levels of thyroid hormones in hyperthyroid patients with untreated Graves' disease. Metabolism. 1997 Oct;46(10):1184-8. doi: 10.1016/s0026-0495(97)90214-6.</citation>
    <PMID>9322804</PMID>
  </results_reference>
  <results_reference>
    <citation>D Purnamasari PS, S Djauzi, S Setiati, A Harahap, J Prihartono. Effects of In Vitro 1,25 Dihydroxyvitamin D on Maturation of Dendritic Cells in Graves' Disease Patients. Asian J Pharm Clin Res. 2016; 9: 221-4</citation>
  </results_reference>
  <results_reference>
    <citation>Handono K, Gani AA, Ekawati M and Wahono S. Serum level of vitamin D and autoantibodies level in systemic lupus erythematosus (SLE) patients. Journal of Pharmacy and Biological Sciences. 2012; 3: 16-20</citation>
  </results_reference>
  <results_reference>
    <citation>Tamaru M, Matsuura B, Onji M. Increased levels of serum interleukin-12 in Graves' disease. Eur J Endocrinol. 1999 Aug;141(2):111-6. doi: 10.1530/eje.0.1410111.</citation>
    <PMID>10427152</PMID>
  </results_reference>
  <results_reference>
    <citation>D Purnamasari PS, S Djauzi. Sunlight-derived vitamin D affects interleukin-4 level, T helper 2 serum cytokines, in patients with Graves' disease: a prospective cohort study. Med J Indones. 2015; 24: 228-33</citation>
  </results_reference>
  <verification_date>February 2020</verification_date>
  <study_first_submitted>December 7, 2016</study_first_submitted>
  <study_first_submitted_qc>December 12, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 15, 2016</study_first_posted>
  <results_first_submitted>July 26, 2017</results_first_submitted>
  <results_first_submitted_qc>February 19, 2020</results_first_submitted_qc>
  <results_first_posted type="Actual">February 20, 2020</results_first_posted>
  <last_update_submitted>February 21, 2020</last_update_submitted>
  <last_update_submitted_qc>February 21, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">March 4, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Dr Cipto Mangunkusumo General Hospital</investigator_affiliation>
    <investigator_full_name>Dyah Purnamasari</investigator_full_name>
    <investigator_title>M.D., Ph.D</investigator_title>
  </responsible_party>
  <keyword>vitamin D</keyword>
  <keyword>graves' disease</keyword>
  <keyword>dendritic cells</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Graves Disease</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Alfacalcidol</mesh_term>
    <mesh_term>Dihydroxycholecalciferols</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
  </patient_data>

  <clinical_results>

    <participant_flow>
      <recruitment_details>May 2014 - May 2015, Patients with Graves' disease who are still in hyperthyroid condition at the outpatient clinic of Endocrinology Department of Dr. Cipto Mangunkusumo Hospital in Jakarta, Indonesia.</recruitment_details>
      <group_list>
        <group group_id="P1">
          <title>PTU + Oral 1α-D3</title>
          <description>patients were given oral 1α-D3 at dose of 1.5 mcg once daily for 8 weeks in addition to propylthiouracil (PTU) 300 mg daily for 8 weeks as the treatment for Graves' disease with thyrotoxicosis&#xD;
1α-D3: patients were given PTU and 1α-D3</description>
        </group>
        <group group_id="P2">
          <title>PTU + Placebos</title>
          <description>patients were given placebo tablets for 8 weeks in addition topropylthiouracil (PTU) 300 mg daily for 8 weeks as the treatment for Graves' disease with thyrotoxicosis&#xD;
Placebos: patients were given PTU and placebos</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="13"/>
                <participants group_id="P2" count="12"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="13"/>
                <participants group_id="P2" count="12"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>PTU + Oral 1α-D3</title>
          <description>patients were given oral 1α-D3 at dose of 1.5 mcg once daily for 8 weeks in addition to propylthiouracil (PTU) 300 mg daily for 8 weeks as the treatment for Graves' disease with thyrotoxicosis&#xD;
1α-D3: patients were given PTU and 1α-D3</description>
        </group>
        <group group_id="B2">
          <title>PTU + Placebos</title>
          <description>patients were given placebo tablets for 8 weeks in addition topropylthiouracil (PTU) 300 mg daily for 8 weeks as the treatment for Graves' disease with thyrotoxicosis&#xD;
Placebos: patients were given PTU and placebos</description>
        </group>
        <group group_id="B3">
          <title>Total</title>
          <description>Total of all reporting groups</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="13"/>
            <count group_id="B2" value="12"/>
            <count group_id="B3" value="25"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="33.67" spread="7.92"/>
                    <measurement group_id="B2" value="38.15" spread="9.34"/>
                    <measurement group_id="B3" value="36" spread="8.81"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="11"/>
                    <measurement group_id="B2" value="12"/>
                    <measurement group_id="B3" value="23"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Duration of illness</title>
          <units>months</units>
          <param>Median</param>
          <dispersion>Full Range</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="18" lower_limit="2" upper_limit="266"/>
                    <measurement group_id="B2" value="27" lower_limit="2" upper_limit="204"/>
                    <measurement group_id="B3" value="24" lower_limit="2" upper_limit="266"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>thyroid-stimulating hormone (TSH) levels</title>
          <units>µIU/l</units>
          <param>Median</param>
          <dispersion>Inter-Quartile Range</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="0.01" lower_limit="0.01" upper_limit="1.86"/>
                    <measurement group_id="B2" value="0.01" lower_limit="0.01" upper_limit="0.01"/>
                    <measurement group_id="B3" value="0.01" lower_limit="0.01" upper_limit="1.86"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>free thyroxine (fT4) levels</title>
          <units>ng/dL</units>
          <param>Median</param>
          <dispersion>Full Range</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="6.9" lower_limit="2.95" upper_limit="7.77"/>
                    <measurement group_id="B2" value="4.2" lower_limit="2.51" upper_limit="7.77"/>
                    <measurement group_id="B3" value="5.04" lower_limit="2.51" upper_limit="7.77"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>TSH receptor antibody (TRAb) levels</title>
          <units>U/L</units>
          <param>Median</param>
          <dispersion>Full Range</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="14.46" lower_limit="3.42" upper_limit="87.74"/>
                    <measurement group_id="B2" value="9.55" lower_limit="3.3" upper_limit="55.4"/>
                    <measurement group_id="B3" value="14.174" lower_limit="3.3" upper_limit="87.74"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Ca ion levels</title>
          <units>mmol/L</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="1.13" spread="0.05"/>
                    <measurement group_id="B2" value="1.13" spread="0.06"/>
                    <measurement group_id="B3" value="1.13" spread="0.05"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Vitamin 25-D3 levels</title>
          <units>ng/mL</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="24.4" spread="7.81"/>
                    <measurement group_id="B2" value="25.55" spread="5.56"/>
                    <measurement group_id="B3" value="25" spread="6.62"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>CD80 Level</title>
        <description>Dendritic cells maturation levels were measured by the CD80 (cluster of differentiation 80)</description>
        <time_frame>1 year</time_frame>
        <group_list>
          <group group_id="O1">
            <title>PTU + Oral 1α-D3</title>
            <description>patients were given oral 1α-D3 at dose of 1.5 mcg once daily for 8 weeks in addition to propylthiouracil (PTU) 300 mg daily for 8 weeks as the treatment for Graves' disease with thyrotoxicosis&#xD;
1α-D3: patients were given PTU and 1α-D3</description>
          </group>
          <group group_id="O2">
            <title>PTU + Placebos</title>
            <description>patients were given placebo tablets for 8 weeks in addition topropylthiouracil (PTU) 300 mg daily for 8 weeks as the treatment for Graves' disease with thyrotoxicosis&#xD;
Placebos: patients were given PTU and placebos</description>
          </group>
        </group_list>
        <measure>
          <title>CD80 Level</title>
          <description>Dendritic cells maturation levels were measured by the CD80 (cluster of differentiation 80)</description>
          <units>nM</units>
          <param>Median</param>
          <dispersion>Full Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="13"/>
                <count group_id="O2" value="12"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="45.60" lower_limit="31.20" upper_limit="139.36"/>
                    <measurement group_id="O2" value="54.51" lower_limit="39.47" upper_limit="69.55"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Other</non_inferiority_type>
            <p_value>0.48</p_value>
            <method>Wilcoxon (Mann-Whitney)</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>CD206 Level</title>
        <description>Dendritic cells maturation levels were measured by the CD206</description>
        <time_frame>1 year</time_frame>
        <group_list>
          <group group_id="O1">
            <title>PTU + Oral 1α-D3</title>
            <description>patients were given oral 1α-D3 at dose of 1.5 mcg once daily for 8 weeks in addition to propylthiouracil (PTU) 300 mg daily for 8 weeks as the treatment for Graves' disease with thyrotoxicosis&#xD;
1α-D3: patients were given PTU and 1α-D3</description>
          </group>
          <group group_id="O2">
            <title>PTU + Placebos</title>
            <description>patients were given placebo tablets for 8 weeks in addition topropylthiouracil (PTU) 300 mg daily for 8 weeks as the treatment for Graves' disease with thyrotoxicosis&#xD;
Placebos: patients were given PTU and placebos</description>
          </group>
        </group_list>
        <measure>
          <title>CD206 Level</title>
          <description>Dendritic cells maturation levels were measured by the CD206</description>
          <units>nM</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="13"/>
                <count group_id="O2" value="12"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="54.08" spread="23.46"/>
                    <measurement group_id="O2" value="53.42" spread="13.72"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Other</non_inferiority_type>
            <p_value>0.47</p_value>
            <method>Wilcoxon (Mann-Whitney)</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>IL-12/IL-10 Ratio</title>
        <description>Dendritic cells maturation levels were measured by the IL-12 (interleukin-12)/IL-10 ratio</description>
        <time_frame>1 year</time_frame>
        <group_list>
          <group group_id="O1">
            <title>PTU + Oral 1α-D3</title>
            <description>patients were given oral 1α-D3 at dose of 1.5 mcg once daily for 8 weeks in addition to propylthiouracil (PTU) 300 mg daily for 8 weeks as the treatment for Graves' disease with thyrotoxicosis&#xD;
1α-D3: patients were given PTU and 1α-D3</description>
          </group>
          <group group_id="O2">
            <title>PTU + Placebos</title>
            <description>patients were given placebo tablets for 8 weeks in addition topropylthiouracil (PTU) 300 mg daily for 8 weeks as the treatment for Graves' disease with thyrotoxicosis&#xD;
Placebos: patients were given PTU and placebos</description>
          </group>
        </group_list>
        <measure>
          <title>IL-12/IL-10 Ratio</title>
          <description>Dendritic cells maturation levels were measured by the IL-12 (interleukin-12)/IL-10 ratio</description>
          <units>ratio</units>
          <param>Median</param>
          <dispersion>Full Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="13"/>
                <count group_id="O2" value="12"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.49" lower_limit="0.04" upper_limit="8.01"/>
                    <measurement group_id="O2" value="0.21" lower_limit="0.03" upper_limit="3.40"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Other</non_inferiority_type>
            <p_value>0.53</p_value>
            <method>Wilcoxon (Mann-Whitney)</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>fT4 Levels</title>
        <description>fT4 (free thyroxine)</description>
        <time_frame>1 year</time_frame>
        <group_list>
          <group group_id="O1">
            <title>PTU + Oral 1α-D3</title>
            <description>patients were given oral 1α-D3 at dose of 1.5 mcg once daily for 8 weeks in addition to propylthiouracil (PTU) 300 mg daily for 8 weeks as the treatment for Graves' disease with thyrotoxicosis&#xD;
1α-D3: patients were given PTU and 1α-D3</description>
          </group>
          <group group_id="O2">
            <title>PTU + Placebos</title>
            <description>patients were given placebo tablets for 8 weeks in addition topropylthiouracil (PTU) 300 mg daily for 8 weeks as the treatment for Graves' disease with thyrotoxicosis&#xD;
Placebos: patients were given PTU and placebos</description>
          </group>
        </group_list>
        <measure>
          <title>fT4 Levels</title>
          <description>fT4 (free thyroxine)</description>
          <units>ng/dL</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="13"/>
                <count group_id="O2" value="12"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.65" spread="2.06"/>
                    <measurement group_id="O2" value="2.09" spread="1.19"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <group_list>
        <group group_id="E1">
          <title>PTU + Oral 1α-D3</title>
          <description>patients were given oral 1α-D3 at dose of 1.5 mcg once daily for 8 weeks in addition to propylthiouracil (PTU) 300 mg daily for 8 weeks as the treatment for Graves' disease with thyrotoxicosis&#xD;
1α-D3: patients were given PTU and 1α-D3</description>
        </group>
        <group group_id="E2">
          <title>PTU + Placebos</title>
          <description>patients were given placebo tablets for 8 weeks in addition topropylthiouracil (PTU) 300 mg daily for 8 weeks as the treatment for Graves' disease with thyrotoxicosis&#xD;
Placebos: patients were given PTU and placebos</description>
        </group>
      </group_list>
      <serious_events>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, all-cause mortality</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="13"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="12"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="13"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="12"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0</frequency_threshold>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="13"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="12"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>All Principal Investigators ARE employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed. </restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Dyah Purnamasari</name_or_title>
      <organization>Dr. Cipto Mangunkusumo Hospital</organization>
      <phone>62213907703</phone>
      <email>dyah_p_irawan@yahoo.com</email>
    </point_of_contact>
  </clinical_results>
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT02993302
org study id: RSCM/FKUI
nct id: NCT02993302
lead sponsor: 
collaborator: 
has dmc: Yes
Maturity level of dendritic cells (DC) plays a pivotal role in initiating and regulating
      autoimmunity. In Graves' disease (GD), DCs have more active immune responses than those in
      healthy subjects. Our previous study demonstrated immunoregulatory effects of in vitro
      1,25-D3 on maturation of DC in GD patients. This study aims to evaluate the effect of oral
      1α-D3 on DC maturation in GD patients.
Patients with Graves' disease were divided into two groups: groups receiving oral 1α-D3 in
      addition to propylthiouracil (PTU) and groups receiving placebos in addition to PTU.
      Comparison of DC maturation were performed before and after the oral 1α-D3. DC maturation was
      assessed based on the expression of DC markers (HLA-DR, CD80, CD40, CD83, CD14 and CD206) and
      the ratio of cytokines interleukin-12/IL-10.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Double (Participant, Outcomes Assessor)
measure: CD80 Level
time frame: 1 year
description: Dendritic cells maturation levels were measured by the CD80 (cluster of differentiation 80)
measure: CD206 Level
time frame: 1 year
description: Dendritic cells maturation levels were measured by the CD206
measure: IL-12/IL-10 Ratio
time frame: 1 year
description: Dendritic cells maturation levels were measured by the IL-12 (interleukin-12)/IL-10 ratio
measure: fT4 Levels
time frame: 1 year
description: fT4 (free thyroxine)
arm group label: PTU-Oral 1α-D3
arm group type: Active Comparator
description: patients were given oral 1α-D3 at dose of 1.5 mcg once daily for 8 weeks in addition to propylthiouracil (PTU) 300 mg daily for 8 weeks as the treatment for Graves' disease with thyrotoxicosis
arm group label: PTU-Placebos
arm group type: Placebo Comparator
description: patients were given placebo tablets for 8 weeks in addition topropylthiouracil (PTU) 300 mg daily for 8 weeks as the treatment for Graves' disease with thyrotoxicosis
intervention type: Drug
intervention name: 1α-D3
description: patients were given PTU and 1α-D3
arm group label: PTU-Oral 1α-D3
other name: 1α 25-dihydroxyvitamin d3
other name: alfacalcidol
intervention type: Drug
intervention name: Placebos
description: patients were given PTU and placebos
arm group label: PTU-Placebos
other name: placebo
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Dyah Purnamasari, M.D., Ph.D
role: Principal Investigator
affiliation: Fakultas Kedokteran Universitas Indonesia
citation: Tamura M, Matsuura B, Miyauchi S, Onji M. Dendritic cells produce interleukin-12 in hyperthyroid mice. Eur J Endocrinol. 1999 Dec;141(6):625-9. doi: 10.1530/eje.0.1410625.
PMID: 10601966
citation: Banchereau J, Steinman RM. Dendritic cells and the control of immunity. Nature. 1998 Mar 19;392(6673):245-52. doi: 10.1038/32588.
PMID: 9521319
citation: Liang S, Ristich V, Arase H, Dausset J, Carosella ED, Horuzsko A. Modulation of dendritic cell differentiation by HLA-G and ILT4 requires the IL-6--STAT3 signaling pathway. Proc Natl Acad Sci U S A. 2008 Jun 17;105(24):8357-62. doi: 10.1073/pnas.0803341105. Epub 2008 Jun 11.
PMID: 18550825
citation: Inoue N, Watanabe M, Morita M, Tatusmi K, Hidaka Y, Akamizu T, Iwatani Y. Association of functional polymorphisms in promoter regions of IL5, IL6 and IL13 genes with development and prognosis of autoimmune thyroid diseases. Clin Exp Immunol. 2011 Mar;163(3):318-23. doi: 10.1111/j.1365-2249.2010.04306.x. Epub 2011 Jan 14.
PMID: 21235536
citation: Khalilzadeh O, Anvari M, Esteghamati A, Momen-Heravi F, Mahmoudi M, Rashidi A, Amiri HM, Ranjbar M, Tabataba-Vakili S, Amirzargar A. The interleukin-1 family gene polymorphisms and Graves' disease. Ann Endocrinol (Paris). 2010 Sep;71(4):281-5. doi: 10.1016/j.ando.2010.01.005. Epub 2010 Apr 18.
PMID: 20400062
citation: Croizet K, Rabilloud R, Kostrouch Z, Nicolas JF, Rousset B. Culture of dendritic cells from a nonlymphoid organ, the thyroid gland: evidence for TNFalpha-dependent phenotypic changes of thyroid-derived dendritic cells. Lab Invest. 2000 Aug;80(8):1215-25. doi: 10.1038/labinvest.3780129.
PMID: 10950112
citation: Dedecjus M, Stasiolek M, Brzezinski J, Selmaj K, Lewinski A. Thyroid hormones influence human dendritic cells' phenotype, function, and subsets distribution. Thyroid. 2011 May;21(5):533-40. doi: 10.1089/thy.2010.0183. Epub 2010 Dec 29.
PMID: 21190445
citation: Hughes GC, Clark EA. Regulation of dendritic cells by female sex steroids: relevance to immunity and autoimmunity. Autoimmunity. 2007 Sep;40(6):470-81. doi: 10.1080/08916930701464764.
PMID: 17729041
citation: Duperrier K, Farre A, Bienvenu J, Bleyzac N, Bernaud J, Gebuhrer L, Rigal D, Eljaafari A. Cyclosporin A inhibits dendritic cell maturation promoted by TNF-alpha or LPS but not by double-stranded RNA or CD40L. J Leukoc Biol. 2002 Nov;72(5):953-61.
PMID: 12429717
citation: Berer A, Stockl J, Majdic O, Wagner T, Kollars M, Lechner K, Geissler K, Oehler L. 1,25-Dihydroxyvitamin D(3) inhibits dendritic cell differentiation and maturation in vitro. Exp Hematol. 2000 May;28(5):575-83. doi: 10.1016/s0301-472x(00)00143-0.
PMID: 10812248
citation: Wahono CS, Rusmini H, Soelistyoningsih D, Hakim R, Handono K, Endharti AT, Kalim H, Widjajanto E. Effects of 1,25(OH)2D3 in immune response regulation of systemic lupus erithematosus (SLE) patient with hypovitamin D. Int J Clin Exp Med. 2014 Jan 15;7(1):22-31. eCollection 2014.
PMID: 24482685
citation: Bartels LE, Jorgensen SP, Bendix M, Hvas CL, Agnholt J, Agger R, Dahlerup JF. 25-Hydroxy vitamin D3 modulates dendritic cell phenotype and function in Crohn's disease. Inflammopharmacology. 2013 Apr;21(2):177-86. doi: 10.1007/s10787-012-0168-y. Epub 2013 Jan 23.
PMID: 23341164
citation: Agmon-Levin N, Theodor E, Segal RM, Shoenfeld Y. Vitamin D in systemic and organ-specific autoimmune diseases. Clin Rev Allergy Immunol. 2013 Oct;45(2):256-66. doi: 10.1007/s12016-012-8342-y.
PMID: 23238772
citation: Zhou H, Xu C, Gu M. Vitamin D receptor (VDR) gene polymorphisms and Graves' disease: a meta-analysis. Clin Endocrinol (Oxf). 2009 Jun;70(6):938-45. doi: 10.1111/j.1365-2265.2008.03413.x. Epub 2008 Sep 8.
PMID: 18782354
citation: Budiyati AD, Setiyono A, Tarigan E and Wibowo H. The effect of alpha fetoprotein on NF-kB translocation in lipopolysaccharide induced monocyte-derived dendritic cell. Med J Indones. 2012; 21.
citation: Hewison M. Vitamin D and the immune system: new perspectives on an old theme. Endocrinol Metab Clin North Am. 2010 Jun;39(2):365-79, table of contents. doi: 10.1016/j.ecl.2010.02.010.
PMID: 20511058
citation: Antico A, Tampoia M, Tozzoli R, Bizzaro N. Can supplementation with vitamin D reduce the risk or modify the course of autoimmune diseases? A systematic review of the literature. Autoimmun Rev. 2012 Dec;12(2):127-36. doi: 10.1016/j.autrev.2012.07.007. Epub 2012 Jul 7.
PMID: 22776787
citation: Hunt PJ, Marshall SE, Weetman AP, Bell JI, Wass JA, Welsh KI. Cytokine gene polymorphisms in autoimmune thyroid disease. J Clin Endocrinol Metab. 2000 May;85(5):1984-8. doi: 10.1210/jcem.85.5.6588.
PMID: 10843185
citation: Bartels LE, Bendix M, Hvas CL, Jorgensen SP, Agnholt J, Agger R, Dahlerup JF. Oral vitamin D3 supplementation reduces monocyte-derived dendritic cell maturation and cytokine production in Crohn's disease patients. Inflammopharmacology. 2014 Apr;22(2):95-103. doi: 10.1007/s10787-013-0197-1. Epub 2013 Dec 29.
PMID: 24374976
citation: Bartosik-Psujek H, Tabarkiewicz J, Pocinska K, Stelmasiak Z, Rolinski J. Immunomodulatory effects of vitamin D on monocyte-derived dendritic cells in multiple sclerosis. Mult Scler. 2010 Dec;16(12):1513-6. doi: 10.1177/1352458510379611. Epub 2010 Aug 25.
PMID: 20739336
citation: Abou-Raya A, Abou-Raya S, Helmii M. The effect of vitamin D supplementation on inflammatory and hemostatic markers and disease activity in patients with systemic lupus erythematosus: a randomized placebo-controlled trial. J Rheumatol. 2013 Mar;40(3):265-72. doi: 10.3899/jrheum.111594. Epub 2012 Dec 1.
PMID: 23204220
citation: Pani MA, Regulla K, Segni M, Hofmann S, Hufner M, Pasquino AM, Usadel KH, Badenhoop K. A polymorphism within the vitamin D-binding protein gene is associated with Graves' disease but not with Hashimoto's thyroiditis. J Clin Endocrinol Metab. 2002 Jun;87(6):2564-7. doi: 10.1210/jcem.87.6.8562.
PMID: 12050214
citation: Yasuda T, Okamoto Y, Hamada N, Miyashita K, Takahara M, Sakamoto F, Miyatsuka T, Kitamura T, Katakami N, Kawamori D, Otsuki M, Matsuoka TA, Kaneto H, Shimomura I. Serum vitamin D levels are decreased in patients without remission of Graves' disease. Endocrine. 2013 Feb;43(1):230-2. doi: 10.1007/s12020-012-9789-6. Epub 2012 Sep 15. No abstract available.
PMID: 22983830
citation: Kawakami-Tani T, Fukawa E, Tanaka H, Abe Y, Makino I. Effect of 1 alpha-hydroxyvitamin D3 on serum levels of thyroid hormones in hyperthyroid patients with untreated Graves' disease. Metabolism. 1997 Oct;46(10):1184-8. doi: 10.1016/s0026-0495(97)90214-6.
PMID: 9322804
citation: D Purnamasari PS, S Djauzi, S Setiati, A Harahap, J Prihartono. Effects of In Vitro 1,25 Dihydroxyvitamin D on Maturation of Dendritic Cells in Graves' Disease Patients. Asian J Pharm Clin Res. 2016; 9: 221-4
citation: Handono K, Gani AA, Ekawati M and Wahono S. Serum level of vitamin D and autoantibodies level in systemic lupus erythematosus (SLE) patients. Journal of Pharmacy and Biological Sciences. 2012; 3: 16-20
citation: Tamaru M, Matsuura B, Onji M. Increased levels of serum interleukin-12 in Graves' disease. Eur J Endocrinol. 1999 Aug;141(2):111-6. doi: 10.1530/eje.0.1410111.
PMID: 10427152
citation: D Purnamasari PS, S Djauzi. Sunlight-derived vitamin D affects interleukin-4 level, T helper 2 serum cytokines, in patients with Graves' disease: a prospective cohort study. Med J Indones. 2015; 24: 228-33
responsible party type: Principal Investigator
investigator affiliation: Dr Cipto Mangunkusumo General Hospital
investigator full name: Dyah Purnamasari
investigator title: M.D., Ph.D
mesh term: Graves Disease
mesh term: Alfacalcidol
mesh term: Dihydroxycholecalciferols
sharing ipd: Undecided
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 