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Trials. 2020 Jan 6;21(1):14. doi: 10.1186/s13063-019-3758-9.

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.

Author information

1
Department of Psychosis Studies, King's College London, Institute of Psychiatry, Psychology and Neuroscience, 16 De Crespigny Park, London, SE5 8AF, UK. fiona.p.gaughran@kcl.ac.uk.
2
South London and Maudsley NHS Foundation Trust, Denmark Hill, London, SE5 8AZ, UK. fiona.p.gaughran@kcl.ac.uk.
3
Department of Biostatistics and Health Informatics, King's College London, Institute of Psychiatry, Psychology and Neuroscience, 16 De Crespigny Park, London, SE5 8AF, UK.
4
Deakin University and Barwon Health, Ryrie Street, Geelong, Victoria, 3220, Australia.
5
Department of Psychosis Studies, King's College London, Institute of Psychiatry, Psychology and Neuroscience, 16 De Crespigny Park, London, SE5 8AF, UK.
6
South London and Maudsley NHS Foundation Trust, Denmark Hill, London, SE5 8AZ, UK.
7
Carer Expert and Chair of Trustees, Rethink Mental Illness, 89 Albert Embankment, London, SE1 7TP, UK.
8
, London, UK.
9
Clinical Trials Facility, Research Department, Tom Rudd Unit, Moorgreen Hospital, Southampton, SO3 03J, UK.
10
Cheshire & Wirral Partnership NHS Trust, Churton House, Countess of Chester Health Park, Chester, CH2 1BQ, UK.
11
South West London and St George's Mental Health NHS Trust, Queen Mary's Hospital, Roehampton Lane, London, SW15 5PN, UK.
12
Queensland Centre for Mental Health Research, The Park Centre for Mental Health, Wacol, QLD, 4076, Australia.
13
Queensland Brain Institute, University of Queensland, Brisbane, QLD, 4072, Australia.
14
National Centre for Register-Based Research, Aarhus University, 8000, Aarhus C, Denmark.

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‚ÄČIU/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.

KEYWORDS:

25OHD; First episode; Mental health; Positive and Negative Syndrome Scale; Psychosis; Randomised controlled trial; Vitamin D

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