Vitamin D Supplementation in Patients With Depression
- Conditions
- Depression
- Interventions
- Dietary Supplement: PlaceboDietary Supplement: vitamin D supplement
- Registration Number
- NCT03766074
- Lead Sponsor
- Tirang R. Neyestani, Ph.D.
- Brief Summary
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
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.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 60
- age: 18 to 60 y
- Having mild to moderate depression
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description control Placebo Placebo every other week Intervention vitamin D supplement vitamin D supplement every other week
- Primary Outcome Measures
Name Time Method significant change (mean±SD) in vitamin D status baseline and 8 weeks after intervention 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
- Secondary Outcome Measures
Name Time Method significant change (mean±SD) in serum concentration of hs-CRP baseline and 8 weeks after intervention 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.
significant change (mean±SD) in platelet serotonin concentration (ng/10^9 platelets) baseline and 8 weeks after intervention The platelet serotonin concentrations (ng/10\^9 platelets) will be measured at baseline and 8 weeks after intervention. normal range is 154-1086.
significant change (mean±SD) in serum concentration of oxytocin (µU/mL) baseline and 8 weeks after intervention 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
significant change (mean±SD) in serum concentration of IL-1β and IL-6. baseline and 8 weeks after intervention The serum concentration of IL-1β and IL-6 (pg/mL) will be measured at baseline and 8 weeks after intervention.
significant change (mean±SD) in serum concentration of bone biomarker baseline and 8 weeks after intervention 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.
significant change (mean±SD) in depression status baseline and 8 weeks after intervention Depression status will be measured by using Beck questioner at baseline and 8 weeks after intervention.
Trial Locations
- Locations (1)
National Nutrition and Food Technology Research Institute
🇮🇷Tehrān, Tehran, Iran, Islamic Republic of