Vitamin D Supplementation in Patients With Depression

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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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

Conditions
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Depression

Intervention / Treatment
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* Dietary Supplement: vitamin D supplement
* Dietary Supplement: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: age: 18 to 60 y Having mild to moderate depression Exclusion Criteria: Having a history of heart infarction Having a history of angina Having a history of stroke Having a history of kidney stones Having a history of high blood pressure (systolic blood pressure higher than 174 or diastolic blood pressure higher than 104 mm Hg) Having a history of liver disease Having a history of hyperparathyroidism Pregnancy and/or lactation Reproductive-aged women (under 50 years old) who are not receiving adequate contraception Consuming nutritional supplement containing vitamin D from 2 months ago Not willing to continue the study Failure to follow the Supplemental Program

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention<br>vitamin D supplement every other week | Dietary Supplement: vitamin D supplement<br>* The intervention group receives 50000 IU of vitamin D every 2 weeks as vitamin D supplements for 8 weeks, provided monthly.<br>|
| Placebo Comparator: control<br>Placebo every other week | Dietary Supplement: Placebo<br>* placebo<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| significant change (mean±SD) in vitamin D status | 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 | baseline and 8 weeks after intervention | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| significant change (mean±SD) in serum concentration of IL-1β and IL-6. | The serum concentration of IL-1β and IL-6 (pg/mL) will be measured at baseline and 8 weeks after intervention. | baseline and 8 weeks after intervention | 
| significant change (mean±SD) in serum concentration of hs-CRP | 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. | baseline and 8 weeks after intervention | 
| significant change (mean±SD) in serum concentration of bone biomarker | 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. | baseline and 8 weeks after intervention | 
| significant change (mean±SD) in platelet serotonin concentration (ng/10^9 platelets) | The platelet serotonin concentrations (ng/10^9 platelets) will be measured at baseline and 8 weeks after intervention. normal range is 154-1086. | baseline and 8 weeks after intervention | 
| significant change (mean±SD) in serum concentration of oxytocin (µU/mL) | 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 | baseline and 8 weeks after intervention | 
| significant change (mean±SD) in depression status | Depression status will be measured by using Beck questioner at baseline and 8 weeks after intervention. | baseline and 8 weeks after intervention | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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vitamin D- Depression- Cholecalciferol-