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)


Study ID: 18385
Short Title: DEFEND
Organisation: Southern Health NHS Foundation Trust
Location: Moorgreen Hospital
Condition: Mental Health
Main Specialty: Mental Health
Expected End Date: 31/05/2019
Postcode: SO30 3JB
Contact Name: SHFT Research
Contact Email: research@southernhealth.nhs.uk
Active: Yes

Inclusion Criteria

The study will be conducted in those with FEP (defined as first presentation in the last six months) attending clinical services run in the South London and Maudsley Hospital NHS Foundation Trust. All patients aged 18-45 years, including women of child-bearing age with a FEP attending the above services will be asked to participate in the trial. Psychosis will be defined according to ICD-10 criteria for psychosis (codes F20-29 and F3033) and confirmed with an OPCRIT (OPerational CRITeria) diagnosis. All participants must have capacity to provide written informed consent and have sufficient English language skills to complete the study. Subjects must agree to refrain from taking multivitamin or non-study vitamin D supplements throughout the study. Participants must be willing to provide a vitamin D blood sample at baseline.

Exclusion Criteria

Patients will be excluded whose diagnosis was evaluated retrospectively and found not to fulfil the diagnostic criteria. Individuals who are suicidal at baseline, those with known endocrine disorders, CVS disease, or diabetes will be excluded. Those with contraindications to Vigantol or prescribed cardiac glycosides Pregnant women and women planning a pregnancy will be excluded.

Study summary:

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)


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