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
Fiona Gaughran,
Dominic Stringer,
Michael Berk,
Shubulade Smith,
David Taylor,
Eromona Whiskey,
Sabine Landau,
Robin Murray,
Philip McGuire,
Poonam Gardner-Sood,
Gabriella Wojewodka,
Simone Ciufolini,
Harriet Jordan,
Jessie Clarke,
Lauren Allen,
Amir Krivoy,
Brendon Stubbs,
Philippa Lowe,
Maurice Arbuthnott,
Shanaya Rathod,
Andrew Boardman,
Mudasir Firdosi,
John J. McGrath
Affiliations
Fiona Gaughran
Department of Psychosis Studies, King’s College London, Institute of Psychiatry, Psychology and Neuroscience
Dominic Stringer
Department of Biostatistics and Health Informatics, King’s College London, Institute of Psychiatry, Psychology and Neuroscience
Michael Berk
Deakin University and Barwon Health
Shubulade Smith
Department of Psychosis Studies, King’s College London, Institute of Psychiatry, Psychology and Neuroscience
David Taylor
South London and Maudsley NHS Foundation Trust
Eromona Whiskey
Department of Psychosis Studies, King’s College London, Institute of Psychiatry, Psychology and Neuroscience
Sabine Landau
Department of Biostatistics and Health Informatics, King’s College London, Institute of Psychiatry, Psychology and Neuroscience
Robin Murray
Department of Psychosis Studies, King’s College London, Institute of Psychiatry, Psychology and Neuroscience
Philip McGuire
Department of Psychosis Studies, King’s College London, Institute of Psychiatry, Psychology and Neuroscience
Poonam Gardner-Sood
Department of Psychosis Studies, King’s College London, Institute of Psychiatry, Psychology and Neuroscience
Gabriella Wojewodka
Department of Psychosis Studies, King’s College London, Institute of Psychiatry, Psychology and Neuroscience
Simone Ciufolini
Department of Psychosis Studies, King’s College London, Institute of Psychiatry, Psychology and Neuroscience
Harriet Jordan
Department of Psychosis Studies, King’s College London, Institute of Psychiatry, Psychology and Neuroscience
Jessie Clarke
Department of Psychosis Studies, King’s College London, Institute of Psychiatry, Psychology and Neuroscience
Lauren Allen
Department of Psychosis Studies, King’s College London, Institute of Psychiatry, Psychology and Neuroscience
Amir Krivoy
Department of Psychosis Studies, King’s College London, Institute of Psychiatry, Psychology and Neuroscience
Brendon Stubbs
Department of Psychosis Studies, King’s College London, Institute of Psychiatry, Psychology and Neuroscience
Philippa Lowe
Carer Expert and Chair of Trustees, Rethink Mental Illness
Maurice Arbuthnott
Shanaya Rathod
Clinical Trials Facility, Research Department, Tom Rudd Unit, Moorgreen Hospital
Andrew Boardman
Cheshire & Wirral Partnership NHS Trust, Churton House
Mudasir Firdosi
South West London and St George’s Mental Health NHS Trust, Queen Mary’s Hospital
John J. McGrath
Queensland Centre for Mental Health Research, The Park Centre for Mental Health
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.
