Vitamin D supplementation and incidence of major depressive disorder - A randomized clinical trial
Abstract
BACKGROUND AND AIMS
Depression is a significant public health issue, but current prevention methods are limited. Vitamin D has shown some promise in treatment of depression, but evidence for primary prevention is inconclusive. We investigated the effects of long-term vitamin D3 supplementation on the incidence of major depressive disorder (MDD).
METHODS
The study was a randomized placebo-controlled clinical trial conducted in 2012-2018. Participants were randomized to receive either 1600 IU/day (n = 814) or 3200 IU/day (n = 817) of vitamin D3 or placebo (n = 803) for 5 years. The primary endpoint of the current study was incident MDD, diagnosed by physician, during the 5-year supplementation period. The secondary endpoint was incident MDD during an extended follow-up until the end of 2021. A sub-cohort of 542 participants had more detailed in-person investigations.
RESULTS
Among 2434 participants (mean age 68.2 years; 42.5 % women), 1786 completed the 5-year intervention. During the mean 4.2-year follow-up, there were 14, 11 and 8 MDD events in the placebo, 1600 IU/day (hazard ratio (HR), 0.78; 95 % CI 0.35-1.71; P = 0.53), and 3200 IU/day (HR, 0.57; 95 % CI 0.24-1.35; P = 0.20) arms. During the extended mean 7.8-year follow-up, there were in total 29, 18 and 16 MDD events in the placebo, 1600 IU/day (HR, 0.61; 95 % CI 0.34-1.10; P = 0.10) and 3200 IU/day (HR 0.54; 95 % CI 0.30-1.00; P = 0.05) arms. In the sub-cohort, the mean ± SD baseline serum 25-hydroxyvitamin D…
How strong is the evidence?
Evidence Hub reads this as a randomized trial, done in people. Its evidence level is 2 of 5 (High · randomized trial). Randomized trials of a reasonable size are the strongest single-study design. Reported size: 2,434 participants or records.
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