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- Title
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.
- Authors
Gaughran, Fiona; Stringer, Dominic; Berk, Michael; Smith, Shubulade; Taylor, David; Whiskey, Eromona; Landau, Sabine; Murray, Robin; McGuire, Philip; Gardner-Sood, Poonam; Wojewodka, Gabriella; Ciufolini, Simone; Jordan, Harriet; Clarke, Jessie; Allen, Lauren; Krivoy, Amir; Stubbs, Brendon; Lowe, Philippa; Arbuthnott, Maurice; Rathod, Shanaya
- Abstract
<bold>Background: </bold>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.<bold>Methods/design: </bold>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.<bold>Discussion: </bold>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.<bold>Trial Registration: </bold>ISRCTN, ISRCTN12424842. Registered on 25 February 2015.
- Subjects
VITAMIN D; VITAMINS; VITAMIN D deficiency; PSYCHOSES; BODY mass index; WAIST circumference; C-reactive protein
- Publication
Trials, 2020, Vol 21, Issue 1, p1
- ISSN
1745-6215
- Publication type
journal article
- DOI
10.1186/s13063-019-3758-9