Related Experiment Video
Updated: Dec 31, 2025

A Method of Trigonometric Modelling of Seasonal Variation Demonstrated with Multiple Sclerosis Relapse Data
Published on: December 9, 2015
Vitamin D supplementation compared to placebo in people with First Episode psychosis - Neuroprotection Design
Fiona Gaughran1,2, Dominic Stringer3, Michael Berk4
1Department of Psychosis Studies, King's College London, Institute of Psychiatry, Psychology and Neuroscience, 16 De Crespigny Park, London, SE5 8AF, UK. fiona.p.gaughran@kcl.ac.uk.
Insights
This study investigated high-dose vitamin D supplementation for early psychosis. Results may clarify the benefits of vitamin D for psychosis patients.
Area of Science:
- Psychiatry and Neuroscience
- Nutritional Science
- Clinical Trials
Background:
- Vitamin D deficiency is common in first-episode psychosis and linked to poorer outcomes.
- Low vitamin D in early life is associated with increased schizophrenia risk.
- Observational studies suggest a link between low vitamin D and psychosis severity.
Purpose of the Study:
- To examine the effect of high-dose vitamin D supplementation on outcomes in early psychosis.
- To investigate if vitamin D supplementation improves mental health in early psychosis.
- To resolve clinical equipoise regarding vitamin D's role in psychosis management.
Main Methods:
- The DFEND study is a multicenter, double-blind, placebo-controlled trial.
- Participants with functional psychosis received 120,000 IU/month of vitamin D or placebo for 6 months.
- Primary outcome: Positive and Negative Syndrome Scale (PANSS) total score at 6 months.
Main Results:
- The primary outcome (PANSS score at 6 months) is currently under analysis.
- Secondary outcomes include mood, general functioning, and cardiovascular risk markers.
- Subgroup analysis of patients with baseline vitamin D inadequacy will be performed.
Conclusions:
- The DFEND study is the first trial to assess vitamin D supplementation's impact on early psychosis outcomes.
- Findings may inform clinical guidelines on routine vitamin D supplementation for psychosis.
- This research could clarify the cost-effectiveness of vitamin D in psychosis treatment.
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.
More Related Videos
04:53A Clinical Trial Assessing the Safety, Efficacy, and Delivery of Olive-Oil-Based Three-Chamber Bags for Parenteral Nutrition
Published on: September 20, 2019
08:20Simultaneous Application of Transcranial Direct Current Stimulation during Virtual Reality Exposure
Published on: January 18, 2021
Related Concept Videos
Role of Skin in Vitamin D Synthesis
The solar UV B rays (290-315 nm) are absorbed by the skin, and 7-dehydrocholesterol (provitamin D3) photolyzes it to previtamin D3, which undergoes a rapid transformation to vitamin...
Bioavailability Study Design: Healthy Subjects Versus Patients
Blinding
Psychosis: Goals of Pharmacotherapy
Psychosis and Antipsychotic Drugs: Overview
Bioavailability Study Design: Single Versus Multiple Dose Studies