<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/NCT04461665</url>
  </required_header>
  <id_info>
    <org_study_id>20150301R</org_study_id>
    <nct_id>NCT04461665</nct_id>
  </id_info>
  <brief_title>Effects of Vitamin D Supplementation on Immune Function in Infants</brief_title>
  <official_title>Effects of Vitamin D Supplementation on Immune Function in Infants</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Shih Chien University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Shin Kong Wu Ho-Su Memorial Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Shih Chien University</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Current study shows that vitamin D deficiency might affect human's immune function. Although&#xD;
      breast milk is the best food of infants, however the vitamin D content in breast milk is low.&#xD;
      Thus, breastfeeding infants are at high risk of vitamin D deficiency.Children's development&#xD;
      and health are always the most important issues for parents. However, high prevalence of&#xD;
      allergy in infants in Taiwan were not only with environmental factor which may also relate to&#xD;
      their nutritional status. The aim of this study was to enroll breastfeeding infant at age of&#xD;
      4 month, and provide vitamin D supplement 10 μg daily until 6 month, to discuss the effects&#xD;
      of vitamin D supplementation on immune function in infants.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Study plan to enroll breastfeeding infant at age of 4 month, and provide vitamin D (vitD)&#xD;
      supplement 10 μg daily until 6 month. we also enroll 6 month-old infant as control group.&#xD;
&#xD;
      All infants collected 5 ml artery blood and measured vitD nutritional status and immune&#xD;
      function. Blood analysis contain complete blood count (CBC), differential count (DC), serum&#xD;
      calcium, serum Parathyroid hormone (PTH), serum 25(OH)D3, serum total immunoglobulinE (IgE)&#xD;
      and cell phagocytosis.&#xD;
&#xD;
      Peripheral blood mononuclear cell (PBMC) in blood was separated and cultured with complete&#xD;
      medium contain 10% fetal bovine serum (CM10), or with different mitogens, include&#xD;
      lipopolysaccharide (LPS), phorbol 12-myristate 13-acetate and ionomycin (PI) and house dust&#xD;
      mite extract (HDM). PBMC are incubated at 37 ℃, 5% CO2 for 48 hours, and determined the&#xD;
      expression of B cell with IgE receptor CD21 and CD23 and T regulatory cell with transcription&#xD;
      factor Foxp3 by flow cytometry. All data were analyzed with SPSS 20.0. Infant sex and feeding&#xD;
      type were analyzed by chi-square analysis. Difference between vitD supplement group and&#xD;
      control group were analyzed by student's t test. Relationship between 25(OH)D3 and Calcium or&#xD;
      PTH were analyzed by pearson correlation analysis. There was a significant difference when&#xD;
      p-value was less than 0.05.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">August 18, 2015</start_date>
  <completion_date type="Actual">December 30, 2016</completion_date>
  <primary_completion_date type="Actual">June 17, 2016</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Non-Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <intervention_model_description>4 months old or 6 months old breastfeeding infants</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Characteristic of infants-1</measure>
    <time_frame>Infants at 4 months old</time_frame>
    <description>Gender in baseline</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Characteristic of infants-2</measure>
    <time_frame>Infants at 4 months old</time_frame>
    <description>Gestational week (week) in baseline</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Characteristic of infants-3</measure>
    <time_frame>Infants at 4 months old</time_frame>
    <description>Birth length (cm) in baseline</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Characteristic of infants-4</measure>
    <time_frame>Infants at 4 months old</time_frame>
    <description>Birth weight (kg) in baseline</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Characteristic of infants-5</measure>
    <time_frame>Infants at 4 months old</time_frame>
    <description>Birth head circumference (cm) in baseline</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Characteristic of infants-6</measure>
    <time_frame>Infants at 4 months old</time_frame>
    <description>Exposed to the sun (min/day) in baseline</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Characteristic of infants-7</measure>
    <time_frame>Infants at 4 months old</time_frame>
    <description>Exclusive breast-fed n (%) in baseline</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Characteristic of infants-8</measure>
    <time_frame>Infants at 4 months old</time_frame>
    <description>Mixed-fed n (%) in baseline</description>
  </primary_outcome>
  <primary_outcome>
    <measure>The anthropometric of infants from 4 months old to 6 months old-1</measure>
    <time_frame>Infants at 4 and 6 months old</time_frame>
    <description>Length percentile (%) in both groups</description>
  </primary_outcome>
  <primary_outcome>
    <measure>The anthropometric of infants from 4 months old to 6 months old-2</measure>
    <time_frame>Infants at 4 and 6 months old</time_frame>
    <description>Weight percentile (%) in both groups</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Vitamin D nutritional status of infants-1</measure>
    <time_frame>Infants at 4 and 6 months old</time_frame>
    <description>Ca (mg/dL) in both groups</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Vitamin D nutritional status of infants-2</measure>
    <time_frame>Infants at 4 and 6 months old</time_frame>
    <description>PTH (pg/mL) in both groups</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Vitamin D nutritional status of infants-3</measure>
    <time_frame>Infants at 4 and 6 months old</time_frame>
    <description>25(OH)D3 (ng/mL) in both groups</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Cell markers expression of B cells</measure>
    <time_frame>Infants at 6 months old</time_frame>
    <description>D21 and CD23 expression (%) in both groups</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Cell markers expression of T cells</measure>
    <time_frame>Infants at 6 months old</time_frame>
    <description>Foxp3 expression (%) in both groups</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Serum immunoglobulin E level of infants</measure>
    <time_frame>Infants at 6 months old</time_frame>
    <description>Concentration of IgE (ng/ml) in both groups</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Cytokine levels in supernatant of lymphocyte by CM-10 induction-1</measure>
    <time_frame>Lymphocyte isolation from Infants at 6 months old</time_frame>
    <description>Concentration of IL-6 (pg/ml) in both groups</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Cytokine levels in supernatant of lymphocyte by CM-10 induction-2</measure>
    <time_frame>Lymphocyte isolation from Infants at 6 months old</time_frame>
    <description>Concentration of IL-4 (pg/ml) in both groups</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Cytokine levels in supernatant of lymphocyte by CM-10 induction-3</measure>
    <time_frame>Lymphocyte isolation from Infants at 6 months old</time_frame>
    <description>Concentration of IL-13 (pg/ml) in both groups</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Cytokine levels in supernatant of lymphocyte by CM-10 induction-4</measure>
    <time_frame>Lymphocyte isolation from Infants at 6 months old</time_frame>
    <description>Concentration of IL-10 (pg/ml) in both groups</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Cytokine levels in supernatant of lymphocyte by CM-10 induction-5</measure>
    <time_frame>Lymphocyte isolation from Infants at 6 months old</time_frame>
    <description>Concentration of TGF-β (pg/ml) in both groups</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Cytokine levels in supernatant of lymphocyte by LPS induction-1</measure>
    <time_frame>Lymphocyte isolation from Infants at 6 months old</time_frame>
    <description>Concentration of IL-6 (pg/ml) in both groups</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Cytokine levels in supernatant of lymphocyte by LPS induction-2</measure>
    <time_frame>Lymphocyte isolation from Infants at 6 months old</time_frame>
    <description>Concentration of TNF-α (pg/ml) in both groups</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Cytokine levels in supernatant of lymphocyte by PI induction-1</measure>
    <time_frame>Lymphocyte isolation from Infants at 6 months old</time_frame>
    <description>Concentration of IL-4 (pg/ml) in both groups</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Cytokine levels in supernatant of lymphocyte by PI induction-2</measure>
    <time_frame>Lymphocyte isolation from Infants at 6 months old</time_frame>
    <description>Concentration of IL-13 (pg/ml) in both groups</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Cytokine levels in supernatant of lymphocyte by PI induction-3</measure>
    <time_frame>Lymphocyte isolation from Infants at 6 months old</time_frame>
    <description>Concentration of IL-10 (pg/ml) in both groups</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Cytokine levels in supernatant of lymphocyte by PI induction-4</measure>
    <time_frame>Lymphocyte isolation from Infants at 6 months old</time_frame>
    <description>Concentration of TGF-β (pg/ml) in both groups</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Cytokine levels in supernatant of lymphocyte by HDM induction-1</measure>
    <time_frame>Lymphocyte isolation from Infants at 6 months old</time_frame>
    <description>Concentration of IFN-γ (pg/ml) in both groups</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Cytokine levels in supernatant of lymphocyte by HDM induction-2</measure>
    <time_frame>Lymphocyte isolation from Infants at 6 months old</time_frame>
    <description>Concentration of IL-4 (pg/ml) in both groups</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Cytokine levels in supernatant of lymphocyte by HDM induction-3</measure>
    <time_frame>Lymphocyte isolation from Infants at 6 months old</time_frame>
    <description>Concentration of IL-13 (pg/ml) in both groups</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Cytokine levels in supernatant of lymphocyte by HDM induction-4</measure>
    <time_frame>Lymphocyte isolation from Infants at 6 months old</time_frame>
    <description>Concentration of IL-10 (pg/ml) in both groups</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Cytokine levels in supernatant of lymphocyte by HDM induction-5</measure>
    <time_frame>Lymphocyte isolation from Infants at 6 months old</time_frame>
    <description>Concentration of TGF-β (pg/ml) in both groups</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">59</enrollment>
  <condition>Vitamin D Deficiency</condition>
  <arm_group>
    <arm_group_label>Control</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Enroll 6 months old breast feeding infant, who have not supplement vitamin D at pediatric clinic.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>VitD supplement</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Enroll 4 months old breast feeding infant, and provide 10 μg vitamin D daily for 2 months.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>vitamin D</intervention_name>
    <description>vitamin D supplement 10 μg daily for 2 months</description>
    <arm_group_label>VitD supplement</arm_group_label>
    <other_name>Baby Ddrops® Liquid Vitamin D3 Vitamin Supplement</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Breastfeeding healthy infants&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  heart disease&#xD;
&#xD;
          -  liver disease&#xD;
&#xD;
          -  lung disease&#xD;
&#xD;
          -  Intestinal disease&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>4 Months</minimum_age>
    <maximum_age>6 Months</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Chao-Ming Chen, MD/PHD</last_name>
    <role>Study Chair</role>
    <affiliation>Shih Chien University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Shih Chien University</name>
      <address>
        <city>Taipei</city>
        <zip>104</zip>
        <country>Taiwan</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Taiwan</country>
  </location_countries>
  <reference>
    <citation>Vasiliou JE, Lui S, Walker SA, Chohan V, Xystrakis E, Bush A, Hawrylowicz CM, Saglani S, Lloyd CM. Vitamin D deficiency induces Th2 skewing and eosinophilia in neonatal allergic airways disease. Allergy. 2014 Oct;69(10):1380-9. doi: 10.1111/all.12465. Epub 2014 Aug 4.</citation>
    <PMID>24943330</PMID>
  </reference>
  <reference>
    <citation>Chawes BL, Bonnelykke K, Jensen PF, Schoos AM, Heickendorff L, Bisgaard H. Cord blood 25(OH)-vitamin D deficiency and childhood asthma, allergy and eczema: the COPSAC2000 birth cohort study. PLoS One. 2014 Jun 12;9(6):e99856. doi: 10.1371/journal.pone.0099856. eCollection 2014.</citation>
    <PMID>24925304</PMID>
  </reference>
  <reference>
    <citation>Dawodu A, Davidson B, Woo JG, Peng YM, Ruiz-Palacios GM, de Lourdes Guerrero M, Morrow AL. Sun exposure and vitamin D supplementation in relation to vitamin D status of breastfeeding mothers and infants in the global exploration of human milk study. Nutrients. 2015 Feb 5;7(2):1081-93. doi: 10.3390/nu7021081.</citation>
    <PMID>25665158</PMID>
  </reference>
  <results_reference>
    <citation>Somashekar AR, Prithvi AB, Gowda MN. Vitamin d levels in children with bronchial asthma. J Clin Diagn Res. 2014 Oct;8(10):PC04-7. doi: 10.7860/JCDR/2014/10387.5055. Epub 2014 Oct 20.</citation>
    <PMID>25478419</PMID>
  </results_reference>
  <verification_date>June 2020</verification_date>
  <study_first_submitted>July 24, 2017</study_first_submitted>
  <study_first_submitted_qc>July 1, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 8, 2020</study_first_posted>
  <last_update_submitted>July 1, 2020</last_update_submitted>
  <last_update_submitted_qc>July 1, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">July 8, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>vitamin D, immune, infants, breastfeeding</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Vitamin D Deficiency</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Vitamin D</mesh_term>
    <mesh_term>Ergocalciferols</mesh_term>
    <mesh_term>Cholecalciferol</mesh_term>
    <mesh_term>Vitamins</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</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/NCT04461665
org study id: 20150301R
nct id: NCT04461665
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Current study shows that vitamin D deficiency might affect human's immune function. Although
      breast milk is the best food of infants, however the vitamin D content in breast milk is low.
      Thus, breastfeeding infants are at high risk of vitamin D deficiency.Children's development
      and health are always the most important issues for parents. However, high prevalence of
      allergy in infants in Taiwan were not only with environmental factor which may also relate to
      their nutritional status. The aim of this study was to enroll breastfeeding infant at age of
      4 month, and provide vitamin D supplement 10 μg daily until 6 month, to discuss the effects
      of vitamin D supplementation on immune function in infants.
Study plan to enroll breastfeeding infant at age of 4 month, and provide vitamin D (vitD)
      supplement 10 μg daily until 6 month. we also enroll 6 month-old infant as control group.

      All infants collected 5 ml artery blood and measured vitD nutritional status and immune
      function. Blood analysis contain complete blood count (CBC), differential count (DC), serum
      calcium, serum Parathyroid hormone (PTH), serum 25(OH)D3, serum total immunoglobulinE (IgE)
      and cell phagocytosis.

      Peripheral blood mononuclear cell (PBMC) in blood was separated and cultured with complete
      medium contain 10% fetal bovine serum (CM10), or with different mitogens, include
      lipopolysaccharide (LPS), phorbol 12-myristate 13-acetate and ionomycin (PI) and house dust
      mite extract (HDM). PBMC are incubated at 37 ℃, 5% CO2 for 48 hours, and determined the
      expression of B cell with IgE receptor CD21 and CD23 and T regulatory cell with transcription
      factor Foxp3 by flow cytometry. All data were analyzed with SPSS 20.0. Infant sex and feeding
      type were analyzed by chi-square analysis. Difference between vitD supplement group and
      control group were analyzed by student's t test. Relationship between 25(OH)D3 and Calcium or
      PTH were analyzed by pearson correlation analysis. There was a significant difference when
      p-value was less than 0.05.
allocation: Non-Randomized
intervention model: Parallel Assignment
intervention model description: 4 months old or 6 months old breastfeeding infants
primary purpose: Treatment
masking: None (Open Label)
measure: Characteristic of infants-1
time frame: Infants at 4 months old
description: Gender in baseline
measure: Characteristic of infants-2
time frame: Infants at 4 months old
description: Gestational week (week) in baseline
measure: Characteristic of infants-3
time frame: Infants at 4 months old
description: Birth length (cm) in baseline
measure: Characteristic of infants-4
time frame: Infants at 4 months old
description: Birth weight (kg) in baseline
measure: Characteristic of infants-5
time frame: Infants at 4 months old
description: Birth head circumference (cm) in baseline
measure: Characteristic of infants-6
time frame: Infants at 4 months old
description: Exposed to the sun (min/day) in baseline
measure: Characteristic of infants-7
time frame: Infants at 4 months old
description: Exclusive breast-fed n (%) in baseline
measure: Characteristic of infants-8
time frame: Infants at 4 months old
description: Mixed-fed n (%) in baseline
measure: The anthropometric of infants from 4 months old to 6 months old-1
time frame: Infants at 4 and 6 months old
description: Length percentile (%) in both groups
measure: The anthropometric of infants from 4 months old to 6 months old-2
time frame: Infants at 4 and 6 months old
description: Weight percentile (%) in both groups
measure: Vitamin D nutritional status of infants-1
time frame: Infants at 4 and 6 months old
description: Ca (mg/dL) in both groups
measure: Vitamin D nutritional status of infants-2
time frame: Infants at 4 and 6 months old
description: PTH (pg/mL) in both groups
measure: Vitamin D nutritional status of infants-3
time frame: Infants at 4 and 6 months old
description: 25(OH)D3 (ng/mL) in both groups
measure: Cell markers expression of B cells
time frame: Infants at 6 months old
description: D21 and CD23 expression (%) in both groups
measure: Cell markers expression of T cells
time frame: Infants at 6 months old
description: Foxp3 expression (%) in both groups
measure: Serum immunoglobulin E level of infants
time frame: Infants at 6 months old
description: Concentration of IgE (ng/ml) in both groups
measure: Cytokine levels in supernatant of lymphocyte by CM-10 induction-1
time frame: Lymphocyte isolation from Infants at 6 months old
description: Concentration of IL-6 (pg/ml) in both groups
measure: Cytokine levels in supernatant of lymphocyte by CM-10 induction-2
time frame: Lymphocyte isolation from Infants at 6 months old
description: Concentration of IL-4 (pg/ml) in both groups
measure: Cytokine levels in supernatant of lymphocyte by CM-10 induction-3
time frame: Lymphocyte isolation from Infants at 6 months old
description: Concentration of IL-13 (pg/ml) in both groups
measure: Cytokine levels in supernatant of lymphocyte by CM-10 induction-4
time frame: Lymphocyte isolation from Infants at 6 months old
description: Concentration of IL-10 (pg/ml) in both groups
measure: Cytokine levels in supernatant of lymphocyte by CM-10 induction-5
time frame: Lymphocyte isolation from Infants at 6 months old
description: Concentration of TGF-β (pg/ml) in both groups
measure: Cytokine levels in supernatant of lymphocyte by LPS induction-1
time frame: Lymphocyte isolation from Infants at 6 months old
description: Concentration of IL-6 (pg/ml) in both groups
measure: Cytokine levels in supernatant of lymphocyte by LPS induction-2
time frame: Lymphocyte isolation from Infants at 6 months old
description: Concentration of TNF-α (pg/ml) in both groups
measure: Cytokine levels in supernatant of lymphocyte by PI induction-1
time frame: Lymphocyte isolation from Infants at 6 months old
description: Concentration of IL-4 (pg/ml) in both groups
measure: Cytokine levels in supernatant of lymphocyte by PI induction-2
time frame: Lymphocyte isolation from Infants at 6 months old
description: Concentration of IL-13 (pg/ml) in both groups
measure: Cytokine levels in supernatant of lymphocyte by PI induction-3
time frame: Lymphocyte isolation from Infants at 6 months old
description: Concentration of IL-10 (pg/ml) in both groups
measure: Cytokine levels in supernatant of lymphocyte by PI induction-4
time frame: Lymphocyte isolation from Infants at 6 months old
description: Concentration of TGF-β (pg/ml) in both groups
measure: Cytokine levels in supernatant of lymphocyte by HDM induction-1
time frame: Lymphocyte isolation from Infants at 6 months old
description: Concentration of IFN-γ (pg/ml) in both groups
measure: Cytokine levels in supernatant of lymphocyte by HDM induction-2
time frame: Lymphocyte isolation from Infants at 6 months old
description: Concentration of IL-4 (pg/ml) in both groups
measure: Cytokine levels in supernatant of lymphocyte by HDM induction-3
time frame: Lymphocyte isolation from Infants at 6 months old
description: Concentration of IL-13 (pg/ml) in both groups
measure: Cytokine levels in supernatant of lymphocyte by HDM induction-4
time frame: Lymphocyte isolation from Infants at 6 months old
description: Concentration of IL-10 (pg/ml) in both groups
measure: Cytokine levels in supernatant of lymphocyte by HDM induction-5
time frame: Lymphocyte isolation from Infants at 6 months old
description: Concentration of TGF-β (pg/ml) in both groups
arm group label: Control
arm group type: No Intervention
description: Enroll 6 months old breast feeding infant, who have not supplement vitamin D at pediatric clinic.
arm group label: VitD supplement
arm group type: Experimental
description: Enroll 4 months old breast feeding infant, and provide 10 μg vitamin D daily for 2 months.
intervention type: Other
intervention name: vitamin D
description: vitamin D supplement 10 μg daily for 2 months
arm group label: VitD supplement
other name: Baby Ddrops® Liquid Vitamin D3 Vitamin Supplement
criteria: 
gender: All
minimum age: 4 Months
maximum age: 6 Months
healthy volunteers: Accepts Healthy Volunteers
last name: Chao-Ming Chen, MD/PHD
role: Study Chair
affiliation: Shih Chien University
facility: 
country: Taiwan
citation: Vasiliou JE, Lui S, Walker SA, Chohan V, Xystrakis E, Bush A, Hawrylowicz CM, Saglani S, Lloyd CM. Vitamin D deficiency induces Th2 skewing and eosinophilia in neonatal allergic airways disease. Allergy. 2014 Oct;69(10):1380-9. doi: 10.1111/all.12465. Epub 2014 Aug 4.
PMID: 24943330
citation: Chawes BL, Bonnelykke K, Jensen PF, Schoos AM, Heickendorff L, Bisgaard H. Cord blood 25(OH)-vitamin D deficiency and childhood asthma, allergy and eczema: the COPSAC2000 birth cohort study. PLoS One. 2014 Jun 12;9(6):e99856. doi: 10.1371/journal.pone.0099856. eCollection 2014.
PMID: 24925304
citation: Dawodu A, Davidson B, Woo JG, Peng YM, Ruiz-Palacios GM, de Lourdes Guerrero M, Morrow AL. Sun exposure and vitamin D supplementation in relation to vitamin D status of breastfeeding mothers and infants in the global exploration of human milk study. Nutrients. 2015 Feb 5;7(2):1081-93. doi: 10.3390/nu7021081.
PMID: 25665158
citation: Somashekar AR, Prithvi AB, Gowda MN. Vitamin d levels in children with bronchial asthma. J Clin Diagn Res. 2014 Oct;8(10):PC04-7. doi: 10.7860/JCDR/2014/10387.5055. Epub 2014 Oct 20.
PMID: 25478419
responsible party type: Sponsor
mesh term: Vitamin D Deficiency
mesh term: Vitamin D
mesh term: Ergocalciferols
mesh term: Cholecalciferol
mesh term: Vitamins
sharing ipd: No