D-fend – Vitamin D First Episode Neuroprotection Design. Version 1
Research type
Research Study
Full title
A randomised, double blind, placebo controlled parallel group trial of vitamin D supplementation compared to placebo in people presenting with their First Episode of psychosis Neuroprotection Design (DFEND)
IRAS ID
147978
Contact name
Fiona Gaughran
Contact email
Sponsor organisation
King’s College London
Eudract number
2014-002639-32
Research summary
There is a growing body of scientific evidence suggesting that vitamin D pathways are important in adult brain function. In particular, there is consistent experimental evidence demonstrating that vitamin D has neuroprotective properties. For example, clinical studies in Parkinson's Disease have found that giving vitamin D supplementation significantly delays progression of the disorder.
Vitamin D insufficiency and deficiency is surprisingly common in many developed nations. Recent studies conducted at the Institute of Psychiatry confirm that over 60% of those presenting with their First Episode of Psychosis (FEP) have vitamin D concentrations less than the recommended levels of 50 nmol/L.
In light of this, and the neuroprotective properties of vitamin D, we believe that there is an urgent need to undertake a well-designed clinical trial of vitamin D supplementation in FEP. We will undertake a double-blind, placebo-controlled, parallel-group study to see whether giving intermittent high-dose vitamin D supplementation to people in the early stages of psychotic illnesses improves health outcomes at one year.
We will use a safe and convenient monthly oral treatment regimen in D-FEND trial.
The study will recruit 240 participants and extend over 12 months, with key outcomes at 6 and 12 months follow-up. For our primary outcome, we propose that vitamin D supplementation will be more effective than placebo in improving outcomes as measured by the Positive and Negative Symptom scale (PANSS) total score at six month follow-up in those with suboptimal vitamin D concentrations at the start of the study. Vitamin D insufficiency, while common, is readily treated with safe, cheap and publicly acceptable dietary supplements. If the D-FEND trial shows better outcomes for those on vitamin D supplementation, this treatment can be readily translated to specialist and primary care settings to improve outcomes for those with psychotic disorders.REC name
London - Dulwich Research Ethics Committee
REC reference
14/LO/1588
Date of REC Opinion
23 Sep 2014
REC opinion
Favourable Opinion