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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.

Gaughran, F; Stringer, D; Berk, M; Smith, S; Taylor, D; Whiskey, E; Landau, S; Murray, R; McGuire, P; Gardner-Sood, P; et al. Gaughran, 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; Rathod, S; Boardman, A; Firdosi, M; McGrath, JJ (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). p. 14. ISSN 1745-6215 https://doi.org/10.1186/s13063-019-3758-9
SGUL Authors: Firdosi, Muhammad Mudasir

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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.

Item Type: Article
Additional Information: © The Author(s). 2020 Open Access This article is distributed under the terms of the Creative Commons Attribution 4.0 International License (http://creativecommons.org/licenses/by/4.0/), which permits unrestricted use, distribution, and reproduction in any medium, provided you give appropriate credit to the original author(s) and the source, provide a link tothe Creative Commons license, and indicate if changes were made. The Creative Commons Public Domain Dedication waiver (http://creativecommons.org/publicdomain/zero/1.0/) applies to the data made available in this article, unless otherwise stated.
Keywords: 25OHD, First episode, Mental health, Positive and Negative Syndrome Scale, Psychosis, Randomised controlled trial, Vitamin D, Adult, Clinical Trials, Phase II as Topic, Dietary Supplements, Double-Blind Method, Female, Follow-Up Studies, Humans, Male, Mental Health, Middle Aged, Neuroprotection, Placebos, Psychiatric Status Rating Scales, Psychotic Disorders, Randomized Controlled Trials as Topic, Treatment Outcome, Vitamin D, Vitamin D Deficiency, Young Adult, Humans, Vitamin D Deficiency, Vitamin D, Placebos, Treatment Outcome, Follow-Up Studies, Double-Blind Method, Mental Health, Psychotic Disorders, Psychiatric Status Rating Scales, Dietary Supplements, Adult, Middle Aged, Female, Male, Randomized Controlled Trials as Topic, Clinical Trials, Phase II as Topic, Young Adult, Neuroprotection, Psychosis, First episode, Vitamin D, 25OHD, Randomised controlled trial, Positive and Negative Syndrome Scale, Mental health, Cardiovascular System & Hematology, General & Internal Medicine, 1102 Cardiorespiratory Medicine and Haematology, 1103 Clinical Sciences
SGUL Research Institute / Research Centre: Academic Structure > Institute of Medical & Biomedical Education (IMBE)
Journal or Publication Title: Trials
ISSN: 1745-6215
Language: eng
Dates:
DateEvent
6 January 2020Published
26 September 2019Accepted
Publisher License: Creative Commons: Attribution 4.0
Projects:
Project IDFunderFunder ID
13T-006Stanley Medical Research Institutehttp://dx.doi.org/10.13039/100007123
ICA-CL-2017-03-001National Institute for Health Researchhttp://dx.doi.org/10.13039/501100000272
APP1056929National Health and Medical Research Councilhttp://dx.doi.org/10.13039/501100000925
PubMed ID: 31907006
Web of Science ID: WOS:000514647500013
Go to PubMed abstract
URI: https://openaccess.sgul.ac.uk/id/eprint/112827
Publisher's version: https://doi.org/10.1186/s13063-019-3758-9

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