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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention | Experimental | vitamin D supplement every other week |
|
| control | Placebo Comparator | Placebo every other week |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| vitamin D supplement | Dietary Supplement | The intervention group receives 50000 IU of vitamin D every 2 weeks as vitamin D supplements for 8 weeks, provided monthly. |
|
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Tirang R. Neyestani, Ph.D | National Nutrition and Food Technology Research Institute | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| National Nutrition and Food Technology Research Institute | Tehrān | Tehran Province | Iran |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36368945 | Derived | Kaviani M, Nikooyeh B, Etesam F, Behnagh SJ, Kangarani HM, Arefi M, Yaghmaei P, Neyestani TR. Effects of vitamin D supplementation on depression and some selected pro-inflammatory biomarkers: a double-blind randomized clinical trial. BMC Psychiatry. 2022 Nov 11;22(1):694. doi: 10.1186/s12888-022-04305-3. |
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| ID | Term |
|---|---|
| D003863 | Depression |
| ID | Term |
|---|---|
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |
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| Placebo | Dietary Supplement | placebo |
|
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 |