Gaughran, F;
Stringer, D;
Wojewodka, G;
Landau, S;
Smith, S;
Gardner-Sood, P;
Taylor, D;
Jordan, H;
Whiskey, E;
Krivoy, A;
et al.
Gaughran, F; Stringer, D; Wojewodka, G; Landau, S; Smith, S; Gardner-Sood, P; Taylor, D; Jordan, H; Whiskey, E; Krivoy, A; Ciufolini, S; Stubbs, B; Casetta, C; Williams, J; Moore, S; Allen, L; Rathod, S; Boardman, A; Khalifa, R; Firdosi, M; McGuire, P; Berk, M; McGrath, J
(2021)
Effect of Vitamin D Supplementation on Outcomes in People With Early Psychosis: The DFEND Randomized Clinical Trial.
JAMA Netw Open, 4 (12).
ISSN 2574-3805
https://doi.org/10.1001/jamanetworkopen.2021.40858
SGUL Authors: Firdosi, Muhammad Mudasir
Abstract
IMPORTANCE: People with psychotic disorders have an increased risk of vitamin D deficiency, which is evident during first-episode psychosis (FEP) and associated with unfavorable mental and physical health outcomes. OBJECTIVE: To examine whether vitamin D supplementation contributes to improved clinical outcomes in FEP. DESIGN, SETTING, AND PARTICIPANTS: This multisite, double-blind, placebo-controlled, parallel-group randomized clinical trial from the UK examined adults 18 to 65 years of age within 3 years of a first presentation with a functional psychotic disorder who had no contraindication to vitamin D supplementation. A total of 2136 patients were assessed for eligibility, 835 were approached, 686 declined participation or were excluded, 149 were randomized, and 104 were followed up at 6 months. The study recruited participants from January 19, 2016, to June 14, 2019, with the final follow-up (after the last dose) completed on December 20, 2019. INTERVENTIONS: Monthly augmentation with 120 000 IU of cholecalciferol or placebo. MAIN OUTCOMES AND MEASURES: The primary outcome measure was total Positive and Negative Syndrome Scale (PANSS) score at 6 months. Secondary outcomes included total PANSS score at 3 months; PANSS positive, negative, and general psychopathology subscale scores at 3 and 6 months; Global Assessment of Function scores (for symptoms and disability); Calgary Depression Scale score, waist circumference, body mass index, and glycated hemoglobin, total cholesterol, C-reactive protein, and vitamin D concentrations at 6 months; and a planned sensitivity analysis in those with insufficient vitamin D levels at baseline. RESULTS: A total of 149 participants (mean [SD] age, 28.1 (8.5) years; 89 [59.7%] male; 65 [43.6%] Black or of other minoritized racial and ethnic group; 84 [56.4%] White [British, Irish, or of other White ethnicity]) were randomized. No differences were observed in the intention-to-treat analysis in the primary outcome, total PANSS score at 6 months (mean difference, 3.57; 95% CI, -1.11 to 8.25; P = .13), or the secondary outcomes at 3 and 6 months (PANSS positive subscore: mean difference, -0.98; 95% CI, -2.23 to 0.27 at 3 months; mean difference, 0.68; 95% CI, -0.69 to 1.99 at 6 months; PANSS negative subscore: mean difference, 0.68; 95% CI, -1.39 to 2.76 at 3 months; mean difference, 1.56; 95% CI, -0.31 to 3.44 at 6 months; and general psychopathology subscore: mean difference, -2.09; 95% CI, -4.36 to 0.18 at 3 months; mean difference, 1.31; 95% CI, -1.42 to 4.05 at 6 months). There also were no significant differences in the Global Assessment of Function symptom score (mean difference, 0.02; 95% CI, -4.60 to 4.94); Global Assessment of Function disability score (mean difference, -0.01; 95% CI, -5.25 to 5.23), or Calgary Depression Scale score (mean difference, -0.39; 95% CI, -2.05 to 1.26) at 6 months. Vitamin D levels were very low in the study group, especially in Black participants and those who identified as another minoritized racial and ethnic group, 57 of 61 (93.4%) of whom had insufficient vitamin D. The treatment was safe and led to a significant increase in 25-hydroxyvitamin D concentrations. CONCLUSIONS AND RELEVANCE: In this randomized clinical trial, no association was found between vitamin D supplementation and mental health or metabolic outcomes at 6 months. Because so few patients with FEP were vitamin D replete, the results of this study suggest that this group would benefit from active consideration in future population health strategies. TRIAL REGISTRATION: isrctn.org Identifier: ISRCTN12424842.
Item Type: |
Article
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Additional Information: |
This is an open access article distributed under the terms of the CC-BY license, which permits unrestricted use, distribution, and reproduction in any medium. You are not required to obtain permission to reuse this article content, provided that you credit the author and journal. |
Keywords: |
Adolescent, Adult, Aged, Double-Blind Method, Female, Humans, Male, Middle Aged, Psychotic Disorders, United Kingdom, Vitamin D, Vitamin D Deficiency, Humans, Vitamin D Deficiency, Vitamin D, Double-Blind Method, Psychotic Disorders, Adolescent, Adult, Aged, Middle Aged, Female, Male, United Kingdom, Adolescent, Adult, Aged, Double-Blind Method, Female, Humans, Male, Middle Aged, Psychotic Disorders, United Kingdom, Vitamin D, Vitamin D Deficiency |
SGUL Research Institute / Research Centre: |
Academic Structure > Institute of Medical & Biomedical Education (IMBE) |
Journal or Publication Title: |
JAMA Netw Open |
Article Number: |
e2140858 |
ISSN: |
2574-3805 |
Language: |
eng |
Dates: |
Date | Event |
---|
1 December 2021 | Published | 28 December 2021 | Published Online | 27 October 2021 | Accepted |
|
Publisher License: |
Creative Commons: Attribution 4.0 |
PubMed ID: |
34962559 |
Web of Science ID: |
WOS:000737965100006 |
![](http://static.pubmed.gov/portal/portal3rc.fcgi/2745237/img/27842) |
Go to PubMed abstract |
URI: |
https://openaccess.sgul.ac.uk/id/eprint/115170 |
Publisher's version: |
https://doi.org/10.1001/jamanetworkopen.2021.40858 |
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