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
AuthorGaughran, F; Stringer, D; Berk, M; Smith, S; Taylor, D; Whiskey, E; Landau, S; Murray, R; McGuire, P; Gardner-Sood, P; ...
Document TypeJournal Article
CitationsGaughran, F., Stringer, D., Berk, M., Smith, S., Taylor, D., Whiskey, E., Landau, S., Murray, R., McGuire, P., Gardner-Sood, P., Wojewodka, G., Ciufolini, S., Jordan, H., Clarke, J., Allen, L., Krivoy, A., Stubbs, B., Lowe, P., Arbuthnott, M. ,... McGrath, J. J. (2020). 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. TRIALS, 21 (1), https://doi.org/10.1186/s13063-019-3758-9.
Access StatusOpen Access
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.
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