<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/NCT03766074</url>
  </required_header>
  <id_info>
    <org_study_id>784</org_study_id>
    <nct_id>NCT03766074</nct_id>
  </id_info>
  <brief_title>Vitamin D Supplementation in Patients With Depression</brief_title>
  <official_title>Evaluation of Vitamin D Supplementation Effects on Serum 25(OH)D3, PTH, Pro-inflammatory Biomarkers and Neurotransmitters Involved in Depression, and Depression Status in Depressive Patients</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Tirang R. Neyestani, Ph.D.</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>National Nutrition and Food Technology Institute</source>
  <oversight_info>
    <has_dmc>Yes</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>
      Groups (intervention group receives 50000 IU vitamin D and control group receives placebo)&#xD;
      through a random allocation. After 8 weeks, blood sample will be collected from each&#xD;
      participant. The studied indices (inflammatory (IL-1β, IL-6, hs-CRP), PTH, platelet&#xD;
      serotonin, serum oxytocin, serum 25(OH) D, depression status and anthropometry indices) will&#xD;
      be evaluated at beginning and end of interventional period.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      In this double-blind randomized clinical trial, 60 patients aged 18-60y referred to Baharlou&#xD;
      hospital with a history of mild to moderate depression diagnosed by a psychiatrist will be&#xD;
      presented to the researcher. After receipt of a signed informed consent form, eligible&#xD;
      patients will participate. A general demographic questionnaire will be completed by an&#xD;
      interviewer. Individuals are randomly divided into intervention and control groups. A 10-ml&#xD;
      venous blood sample will be collected from each participant. The intervention group receives&#xD;
      50000 IU of vitamin D every 2 weeks as vitamin D supplements for 8 weeks, provided monthly.&#xD;
      The control group receives placebo. The drug schedule of both groups (if any) will be&#xD;
      unchanged according to the prescribing physician. After 8 weeks, blood sample will be&#xD;
      collected from each participant. The studied indices (inflammatory (IL-1β, IL-6, hs-CRP),&#xD;
      PTH, platelet serotonin, serum oxytocin, serum 25(OH) D, depression status, anthropometry&#xD;
      indices) will be evaluated at beginning and end of interventional period. Data will be&#xD;
      analyzed by statistical tests.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Active, not recruiting</last_known_status>
  <start_date type="Actual">May 6, 2018</start_date>
  <completion_date type="Anticipated">September 2019</completion_date>
  <primary_completion_date type="Anticipated">April 2019</primary_completion_date>
  <phase>N/A</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>Supportive Care</primary_purpose>
    <masking>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>significant change (mean±SD) in vitamin D status</measure>
    <time_frame>baseline and 8 weeks after intervention</time_frame>
    <description>The serum concentration of 25(OH) D (nmol/L) will be measured at baseline and 8 weeks after intervention. normal range is 25-162 nmol/L</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>significant change (mean±SD) in serum concentration of IL-1β and IL-6.</measure>
    <time_frame>baseline and 8 weeks after intervention</time_frame>
    <description>The serum concentration of IL-1β and IL-6 (pg/mL) will be measured at baseline and 8 weeks after intervention.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>significant change (mean±SD) in serum concentration of hs-CRP</measure>
    <time_frame>baseline and 8 weeks after intervention</time_frame>
    <description>The serum concentration of hs-CRP (mg/L) will be measured at baseline and 8 weeks after intervention. normal range is 0.3-8.6 mg/L.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>significant change (mean±SD) in serum concentration of bone biomarker</measure>
    <time_frame>baseline and 8 weeks after intervention</time_frame>
    <description>The serum concentration of parathormone (PTH) (pg/mL) will be measured at baseline and 8 weeks after intervention. normal range is 10-65 pg/mL.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>significant change (mean±SD) in platelet serotonin concentration (ng/10^9 platelets)</measure>
    <time_frame>baseline and 8 weeks after intervention</time_frame>
    <description>The platelet serotonin concentrations (ng/10^9 platelets) will be measured at baseline and 8 weeks after intervention. normal range is 154-1086.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>significant change (mean±SD) in serum concentration of oxytocin (µU/mL)</measure>
    <time_frame>baseline and 8 weeks after intervention</time_frame>
    <description>The serum concentrations of oxytocin (µU/mL) will be measured at baseline and 8 weeks after intervention. normal range is : males:1.1-1.9, females (non-pregnant): 1.0-1.8</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>significant change (mean±SD) in depression status</measure>
    <time_frame>baseline and 8 weeks after intervention</time_frame>
    <description>Depression status will be measured by using Beck questioner at baseline and 8 weeks after intervention.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">60</enrollment>
  <condition>Depression</condition>
  <arm_group>
    <arm_group_label>Intervention</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>vitamin D supplement every other week</description>
  </arm_group>
  <arm_group>
    <arm_group_label>control</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Placebo every other week</description>
  </arm_group>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>vitamin D supplement</intervention_name>
    <description>The intervention group receives 50000 IU of vitamin D every 2 weeks as vitamin D supplements for 8 weeks, provided monthly.</description>
    <arm_group_label>Intervention</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <description>placebo</description>
    <arm_group_label>control</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  age: 18 to 60 y&#xD;
&#xD;
          -  Having mild to moderate depression&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Having a history of heart infarction&#xD;
&#xD;
          -  Having a history of angina&#xD;
&#xD;
          -  Having a history of stroke&#xD;
&#xD;
          -  Having a history of kidney stones&#xD;
&#xD;
          -  Having a history of high blood pressure (systolic blood pressure higher than 174 or&#xD;
             diastolic blood pressure higher than 104 mm Hg)&#xD;
&#xD;
          -  Having a history of liver disease&#xD;
&#xD;
          -  Having a history of hyperparathyroidism&#xD;
&#xD;
          -  Pregnancy and/or lactation&#xD;
&#xD;
          -  Reproductive-aged women (under 50 years old) who are not receiving adequate&#xD;
             contraception&#xD;
&#xD;
          -  Consuming nutritional supplement containing vitamin D from 2 months ago&#xD;
&#xD;
          -  Not willing to continue the study&#xD;
&#xD;
          -  Failure to follow the Supplemental Program&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>60 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Tirang R. Neyestani, Ph.D</last_name>
    <role>Study Chair</role>
    <affiliation>National Nutrition and Food Technology Research Institute</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>National Nutrition and Food Technology Research Institute</name>
      <address>
        <city>Tehrān</city>
        <state>Tehran</state>
        <country>Iran, Islamic Republic of</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Iran, Islamic Republic of</country>
  </location_countries>
  <verification_date>December 2018</verification_date>
  <study_first_submitted>December 4, 2018</study_first_submitted>
  <study_first_submitted_qc>December 4, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 5, 2018</study_first_posted>
  <last_update_submitted>December 11, 2018</last_update_submitted>
  <last_update_submitted_qc>December 11, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">December 13, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor-Investigator</responsible_party_type>
    <investigator_affiliation>National Nutrition and Food Technology Institute</investigator_affiliation>
    <investigator_full_name>Tirang R. Neyestani, Ph.D.</investigator_full_name>
    <investigator_title>Tirang R. Neyestani, Ph.D. Professor</investigator_title>
  </responsible_party>
  <keyword>vitamin D- Depression- Cholecalciferol-</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Depression</mesh_term>
    <mesh_term>Depressive Disorder</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Vitamin D</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>Undecided</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/NCT03766074
org study id: 784
nct id: NCT03766074
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
Groups (intervention group receives 50000 IU vitamin D and control group receives placebo)
      through a random allocation. After 8 weeks, blood sample will be collected from each
      participant. The studied indices (inflammatory (IL-1β, IL-6, hs-CRP), PTH, platelet
      serotonin, serum oxytocin, serum 25(OH) D, depression status and anthropometry indices) will
      be evaluated at beginning and end of interventional period.
In this double-blind randomized clinical trial, 60 patients aged 18-60y referred to Baharlou
      hospital with a history of mild to moderate depression diagnosed by a psychiatrist will be
      presented to the researcher. After receipt of a signed informed consent form, eligible
      patients will participate. A general demographic questionnaire will be completed by an
      interviewer. Individuals are randomly divided into intervention and control groups. A 10-ml
      venous blood sample will be collected from each participant. The intervention group receives
      50000 IU of vitamin D every 2 weeks as vitamin D supplements for 8 weeks, provided monthly.
      The control group receives placebo. The drug schedule of both groups (if any) will be
      unchanged according to the prescribing physician. After 8 weeks, blood sample will be
      collected from each participant. The studied indices (inflammatory (IL-1β, IL-6, hs-CRP),
      PTH, platelet serotonin, serum oxytocin, serum 25(OH) D, depression status, anthropometry
      indices) will be evaluated at beginning and end of interventional period. Data will be
      analyzed by statistical tests.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Supportive Care
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: significant change (mean±SD) in vitamin D status
time frame: baseline and 8 weeks after intervention
description: The serum concentration of 25(OH) D (nmol/L) will be measured at baseline and 8 weeks after intervention. normal range is 25-162 nmol/L
measure: significant change (mean±SD) in serum concentration of IL-1β and IL-6.
time frame: baseline and 8 weeks after intervention
description: The serum concentration of IL-1β and IL-6 (pg/mL) will be measured at baseline and 8 weeks after intervention.
measure: significant change (mean±SD) in serum concentration of hs-CRP
time frame: baseline and 8 weeks after intervention
description: The serum concentration of hs-CRP (mg/L) will be measured at baseline and 8 weeks after intervention. normal range is 0.3-8.6 mg/L.
measure: significant change (mean±SD) in serum concentration of bone biomarker
time frame: baseline and 8 weeks after intervention
description: The serum concentration of parathormone (PTH) (pg/mL) will be measured at baseline and 8 weeks after intervention. normal range is 10-65 pg/mL.
measure: significant change (mean±SD) in platelet serotonin concentration (ng/10^9 platelets)
time frame: baseline and 8 weeks after intervention
description: The platelet serotonin concentrations (ng/10^9 platelets) will be measured at baseline and 8 weeks after intervention. normal range is 154-1086.
measure: significant change (mean±SD) in serum concentration of oxytocin (µU/mL)
time frame: baseline and 8 weeks after intervention
description: The serum concentrations of oxytocin (µU/mL) will be measured at baseline and 8 weeks after intervention. normal range is : males:1.1-1.9, females (non-pregnant): 1.0-1.8
measure: significant change (mean±SD) in depression status
time frame: baseline and 8 weeks after intervention
description: Depression status will be measured by using Beck questioner at baseline and 8 weeks after intervention.
arm group label: Intervention
arm group type: Experimental
description: vitamin D supplement every other week
arm group label: control
arm group type: Placebo Comparator
description: Placebo every other week
intervention type: Dietary Supplement
intervention name: vitamin D supplement
description: The intervention group receives 50000 IU of vitamin D every 2 weeks as vitamin D supplements for 8 weeks, provided monthly.
arm group label: Intervention
intervention type: Dietary Supplement
intervention name: Placebo
description: placebo
arm group label: control
criteria: 
gender: All
minimum age: 18 Years
maximum age: 60 Years
healthy volunteers: No
last name: Tirang R. Neyestani, Ph.D
role: Study Chair
affiliation: National Nutrition and Food Technology Research Institute
facility: 
country: Iran, Islamic Republic of
responsible party type: Sponsor-Investigator
investigator affiliation: National Nutrition and Food Technology Institute
investigator full name: Tirang R. Neyestani, Ph.D.
investigator title: Tirang R. Neyestani, Ph.D. Professor
mesh term: Depression
mesh term: Depressive Disorder
mesh term: Vitamin D
sharing ipd: Undecided