1. The DFEND double-blind, randomized controlled trial revealed that Vitamin D supplementation led to no improvements in clinical outcomes at 6-months, as measured by the Positive and Negative Syndrome Scale, among patients with first-episode psychosis compared to placebo.
Evidence Rating Level: 1 (Excellent)
Study Rundown: Recent evidence indicates that individuals with psychosis are more likely to be Vitamin D deficient than the remainder of the population. Low Vitamin D is associated with brain-related changes, which has resulted in speculation that optimizing Vitamin D levels may improve outcomes. However, there has yet to be a study demonstrating the benefit of Vitamin D supplementation for psychosis. The DFEND randomized controlled trial investigated whether Vitamin D supplementation can improve clinical outcomes in patients with first-episode psychosis (FEP) compared to placebo. The primary outcome (measurement of clinical improvement) was Positive and Negative Syndrome Scale (PANSS) at 6 months, where a reduction in scores indicates improvement. PANSS contains positive, negative, and general psychopathology subscores. Participants (149 included in the primary analysis) diagnosed with functional psychosis were recruited from January 19, 2016 until June 14, 2019 and were randomized 1:1 to receive 120 000 IU of Vitamin D3 (cholecalciferol) or placebo. At 6 months, there was no group difference in PANSS total score between the Vitamin D group versus the placebo group (mean difference [MD]: 3.57 [95% CI: -1.11 to 8.25]; p= 0.13). When breaking down PANSS components, no group difference was found in PANSS positive score (MD: 0.68 [95% CI: -0.69 to 1.99]; p= 0.34), PANSS negative score (MD: 1.56 [95% CI: -0.31 to 3.44]; p= 0.10), and PANSS general psychopathology score (MD: 1.31 [95% CI: -1.42 to 4.05]; p= 0.34) at 6 months. Furthermore, no differences were found in Global Assessment of Function symptom (MD: 0.02 [95% CI: -4.60 to 4.94]) or disability (MD: -0.01 [95% CI: -5.25 to 5.23]) scores and cardiometabolic risk factors (waist circumference, body mass index, glycated hemoglobin, and total cholesterol) between groups. Overall, the DFEND clinical trial demonstrated that Vitamin D supplementation in patients with FEP does not improve mental health outcomes compared to placebo. One limitation of this study is that outcomes were assessed for 6-months, however, vitamin-D-related improvements may require longer term observation of treatment and follow-up.
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