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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

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  • Fiona Gaughran, South London and Maudsley NHS Foundation Trust, Denmark Hill, London, SE5 8AZ, UK. fiona.p.gaughran@kcl.ac.uk.
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  • Dominic Stringer, Department of Biostatistics and Health Informatics, King's College London, Institute of Psychiatry, Psychology and Neuroscience, 16 De Crespigny Park, London, SE5 8AF, UK.
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  • Michael Berk, Deakin University and Barwon Health, Ryrie Street, Geelong, Victoria, 3220, Australia.
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  • Shubulade Smith, South London and Maudsley NHS Foundation Trust, Denmark Hill, London, SE5 8AZ, UK.
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  • David Taylor, South London and Maudsley NHS Foundation Trust, Denmark Hill, London, SE5 8AZ, UK.
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  • Eromona Whiskey, South London and Maudsley NHS Foundation Trust, Denmark Hill, London, SE5 8AZ, UK.
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  • Sabine Landau, Department of Biostatistics and Health Informatics, King's College London, Institute of Psychiatry, Psychology and Neuroscience, 16 De Crespigny Park, London, SE5 8AF, UK.
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  • Robin Murray, South London and Maudsley NHS Foundation Trust, Denmark Hill, London, SE5 8AZ, UK.
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  • Philip McGuire, South London and Maudsley NHS Foundation Trust, Denmark Hill, London, SE5 8AZ, UK.
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  • Poonam Gardner-Sood, South London and Maudsley NHS Foundation Trust, Denmark Hill, London, SE5 8AZ, UK.
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  • Gabriella Wojewodka, Department of Psychosis Studies, King's College London, Institute of Psychiatry, Psychology and Neuroscience, 16 De Crespigny Park, London, SE5 8AF, UK.
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  • Simone Ciufolini, South London and Maudsley NHS Foundation Trust, Denmark Hill, London, SE5 8AZ, UK.
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  • Harriet Jordan, Department of Psychosis Studies, King's College London, Institute of Psychiatry, Psychology and Neuroscience, 16 De Crespigny Park, London, SE5 8AF, UK.
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  • Jessie Clarke, Department of Psychosis Studies, King's College London, Institute of Psychiatry, Psychology and Neuroscience, 16 De Crespigny Park, London, SE5 8AF, UK.
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  • Lauren Allen, Department of Psychosis Studies, King's College London, Institute of Psychiatry, Psychology and Neuroscience, 16 De Crespigny Park, London, SE5 8AF, UK.
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  • Amir Krivoy, South London and Maudsley NHS Foundation Trust, Denmark Hill, London, SE5 8AZ, UK.
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  • Brendon Stubbs, South London and Maudsley NHS Foundation Trust, Denmark Hill, London, SE5 8AZ, UK.
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  • Philippa Lowe, Carer Expert and Chair of Trustees, Rethink Mental Illness, 89 Albert Embankment, London, SE1 7TP, UK.
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  • Maurice Arbuthnott, Queen Marys Univ London, Queen Mary University London, University of London, Barts & London Sch Med & Dent
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  • Shanaya Rathod, Clinical Trials Facility, Research Department, Tom Rudd Unit, Moorgreen Hospital, Southampton, SO3 03J, UK.
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  • Andrew Boardman, Cheshire & Wirral Partnership NHS Trust, Churton House, Countess of Chester Health Park, Chester, CH2 1BQ, UK.
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  • Mudasir Firdosi, South West London and St George's Mental Health NHS Trust, Queen Mary's Hospital, Roehampton Lane, London, SW15 5PN, UK.
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  • John J McGrath

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.

OriginalsprogEngelsk
Artikelnummer14
TidsskriftTrials
Vol/bind21
Nummer1
Antal sider12
ISSN1468-6708
DOI
StatusUdgivet - 6 jan. 2020

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