Effects of Vitamin D Supplementation on Depression and Inflammatory Markers
Effects of Vitamin D Supplementation on Depression and Inflammatory Markers
NCT ID: NCT04898725 Phase: NA Status: COMPLETED Enrollment: 142 Completion: 2024-07-31
Conditions
Major Depression, Vitamin D Deficiency
Interventions
Vitamin D3
Summary
The current study is designed as a prospective partially randomized patient preference (PRPP) trial and recruit psychiatric outpatients or inpatients. Participants who agree to receive randomization will be randomly assigned into a supplementation or placebo group, after stratification for pre-intervention vitamin D status (12-20 ng/mL or \<12 ng/mL) and depression status (HDRS-17 ≥ 17 or \< 17). Participants who decline randomization but agree to receive follow-up in the observational cohort choose their preferred method (either 4800 IU vitamin D3 per day, or usual care without supplementation). Severity of depression, any change of medication, and side effect will be assessed at baseline and at 2-week intervals for 8 weeks. Serum levels of 25(OH)D, C-Reactive protein (CRP) and 12 cytokines, anthropometrical measurements, dietary intake, physical activity and sun exposure will be assessed at baseline and post-intervention. Additionally, serum levels of 25(OH)D will be assessed at 4 weeks to ensure its safety level.
Primary Outcome
Change of total score of 17-item Hamilton Depression Rating Scale (HDRS-17)