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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, Fiona, Stringer, Dominic, Berk, Michael, Smith, Shubulade, Taylor, David, Whiskey, Eromona, Landau, Sabine, Murray, Robin, McGuire, Philip, Gardner-Sood, Poonam, Wojewodka, Gabriella, Ciufolini, Simone, Jordan, Harriet, Clarke, Jessie, Allen, Lauren, Krivoy, Amir, Stubbs, Brendon, Lowe, Philippa, Arbuthnott, Maurice, Rathod, Shanaya, Boardman, Andrew, Firdosi, Mudasir and McGrath, John 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, vol. 21, pp. 1-12, doi: 10.1186/s13063-019-3758-9.

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Title 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(s) Gaughran, Fiona
Stringer, Dominic
Berk, MichaelORCID iD for Berk, Michael orcid.org/0000-0002-5554-6946
Smith, Shubulade
Taylor, David
Whiskey, Eromona
Landau, Sabine
Murray, Robin
McGuire, Philip
Gardner-Sood, Poonam
Wojewodka, Gabriella
Ciufolini, Simone
Jordan, Harriet
Clarke, Jessie
Allen, Lauren
Krivoy, Amir
Stubbs, Brendon
Lowe, Philippa
Arbuthnott, Maurice
Rathod, Shanaya
Boardman, Andrew
Firdosi, Mudasir
McGrath, John J.
Journal name Trials
Volume number 21
Article ID 14
Start page 1
End page 12
Total pages 12
Publisher BMC
Place of publication London, Eng.
Publication date 2020-01
ISSN 1745-6215
Keyword(s) Science & Technology
Life Sciences & Biomedicine
Medicine, Research & Experimental
Research & Experimental Medicine
Psychosis
First episode
Vitamin D
25OHD
Randomised controlled trial
Positive and Negative Syndrome Scale
Mental health
DEPRESSION RATING-SCALE
D DEFICIENCY
GLOBAL ASSESSMENT
METABOLIC SYNDROME
MENTAL-ILLNESS
SCHIZOPHRENIA
METAANALYSIS
VALIDITY
RISK
RELIABILITY
Summary 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. 
Language eng
DOI 10.1186/s13063-019-3758-9
Indigenous content off
Field of Research 110999 Neurosciences not elsewhere classified
1102 Cardiorespiratory Medicine and Haematology
1103 Clinical Sciences
Socio Economic Objective 920410 Mental Health
HERDC Research category C1 Refereed article in a scholarly journal
Free to Read? Yes
Persistent URL http://hdl.handle.net/10536/DRO/DU:30133493

Document type: Journal Article
Collections: Faculty of Health
School of Medicine
Open Access Collection
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Every reasonable effort has been made to ensure that permission has been obtained for items included in DRO. If you believe that your rights have been infringed by this repository, please contact drosupport@deakin.edu.au.