Vitamin D supplementation compared to placebo in people with First Episode psychosis - Neuroprotection Design (DFEND): a protocol for a randomised, double-blind, placebo-controlled, parallel-group trial

Journal article

Abstract Background People experiencing their first episode of psychosis are often deficient in vitamin D. Observational studies have reported an association between low vitamin D concentrations and poorer subsequent health outcomes in psychosis. A vitamin D deficiency in neonates and children has been linked to a later increased risk of schizophrenia and psychotic-like experiences. This trial aims to examine the effect of high-dose vitamin D supplementation on outcomes in early psychosis. We hypothesise that vitamin D supplementation will be associated with better mental health outcomes. Methods/design The DFEND study is a multicentre double-blind placebo-controlled parallel-group trial of vitamin D supplementation in people with early psychosis. Patients with an ICD-10 diagnosis of functional psychosis will be randomised in a 1:1 ratio to receive either 120,000 IU/month of vitamin D (cholecalciferol) or a matched placebo for 6 months. The primary outcome is the total Positive and Negative Syndrome Scale (PANSS) score at the 6-month follow-up for all patients. Secondary outcomes include assessment of mood (Calgary Depression Scale), general function (Global Assessment of Functioning), cardiovascular risk (body mass index, waist circumference, C-reactive protein, cholesterol and HbA1c) and vitamin D levels at the 6-month follow-up. Additionally, 3- and 6-month total PANSS scores will be analysed for those with inadequate vitamin D levels at the baseline. Discussion The DFEND study is the first trial to examine whether vitamin D supplementation in early psychosis is associated with better mental health outcomes. The findings of this study may help to resolve the clinical equipoise regarding the benefits and cost-effectiveness of routine vitamin D supplementation in people with psychosis. Trial registration ISRCTN, ISRCTN12424842. Registered on 25 February 2015.

Authors: Gaughran, F; Stringer, D; Berk, M; Smith, S; Taylor, D

• Publication status: Published
• Peer review status: Peer reviewed
• Publisher: BioMed Central
• Journal: Trials
• Volume: 21
• Issue: 1
• Pages: 14-14
• Publication date: 2020-01-06
• DOI: 10.1186/s13063-019-3758-9
• EISSN: 1745-6215
• ISSN: 1745-6215
• Language: English
• Keywords: Body mass index; Pediatrics; Psychiatry; Placebo; Medicine; Vitamin D and neurology; Positive and Negative Syndrome Scale; Schizophrenia (object-oriented programming); Randomized controlled trial; Psychosis; vitamin D deficiency; Internal medicine