Depression
Conditions
Keywords
vitamin D- Depression- Cholecalciferol-
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.
Interventions
DIETARY_SUPPLEMENTvitamin D supplement
The intervention group receives 50000 IU of vitamin D every 2 weeks as vitamin D supplements for 8 weeks, provided monthly.
DIETARY_SUPPLEMENTPlacebo
placebo
Sponsors
Tirang R. Neyestani, Ph.D.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 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 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 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 depression status | baseline and 8 weeks after intervention | Depression status will be measured by using Beck questioner at baseline and 8 weeks after intervention. |
| 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. |
Countries
Iran
Outcome results
None listed