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 RathodAndrew Boardman, Mudasir Firdosi, John J. McGrath

*Corresponding author for this work

Research output: Contribution to journalArticlepeer-review

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.

Original languageEnglish
Article number14
JournalTrials
Volume21
Issue number1
DOIs
StatePublished - 6 Jan 2020
Externally publishedYes

Keywords

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

Fingerprint

Dive into the research topics of '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'. Together they form a unique fingerprint.

Cite this