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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
QUADRUPLE
Enrollment
60
The intervention group receives 50000 IU of vitamin D every 2 weeks as vitamin D supplements for 8 weeks, provided monthly.
placebo
National Nutrition and Food Technology Research Institute
Tehrān, Tehran Province, Iran
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
Time frame: baseline and 8 weeks after intervention
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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
Time frame: baseline and 8 weeks after intervention
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
significant change (mean±SD) in depression status
Depression status will be measured by using Beck questioner at baseline and 8 weeks after intervention.
Time frame: baseline and 8 weeks after intervention