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.
Adult
Clinical Trials, Phase II as Topic
Dietary Supplements
Double-Blind Method
Female
Follow-Up Studies
Humans
Male
Mental Health
Middle Aged
Neuroprotection
/ drug effects
Placebos
/ administration & dosage
Psychiatric Status Rating Scales
/ statistics & numerical data
Psychotic Disorders
/ blood
Randomized Controlled Trials as Topic
Treatment Outcome
Vitamin D
/ administration & dosage
Vitamin D Deficiency
/ blood
Young Adult
25OHD
First episode
Mental health
Positive and Negative Syndrome Scale
Psychosis
Randomised controlled trial
Vitamin D
Journal
Trials
ISSN: 1745-6215
Titre abrégé: Trials
Pays: England
ID NLM: 101263253
Informations de publication
Date de publication:
06 Jan 2020
06 Jan 2020
Historique:
received:
27
03
2019
accepted:
26
09
2019
entrez:
8
1
2020
pubmed:
8
1
2020
medline:
18
11
2020
Statut:
epublish
Résumé
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. 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. 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. ISRCTN, ISRCTN12424842. Registered on 25 February 2015.
Sections du résumé
BACKGROUND
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
METHODS
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
CONCLUSIONS
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
BACKGROUND
ISRCTN, ISRCTN12424842. Registered on 25 February 2015.
Identifiants
pubmed: 31907006
doi: 10.1186/s13063-019-3758-9
pii: 10.1186/s13063-019-3758-9
pmc: PMC6945550
doi:
Substances chimiques
Placebos
0
Vitamin D
1406-16-2
Types de publication
Clinical Trial Protocol
Journal Article
Langues
eng
Sous-ensembles de citation
IM
Pagination
14Subventions
Organisme : Stanley Medical Research Institute
ID : 13T-006
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