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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 (DFEND)

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This study aims to explore how the addition of vitamin D supplements to standard treatments can help people recover after having their first episode of psychosis.

Vitamin D is often referred to as the 'sunshine hormone' on account of sufficient production in the body being dependent on regular access to strong sunshine. This can problematic in the UK with people often being deficit in vitamin D due to our lack of strong sunshine.

There is a growing body of evidence showing that vitamin D may be important for a healthy functioning brain. vitamin D acts as what is known as 'neuroprotective'. Therefore this study aims to determine whether or not vitamin D can help recovery in first episode psychosis.

What is involved?

Participants of the study will continue to receive their standard treatments for psychosis. Half of the participants will be randomly allocated to receive a vitamin D supplement while the other half will receive a placebo treatment.

If randomised to receive vitamin D supplements, participants will be asked to take six drops (around one and a half teaspoons) of vitamin D supplement once a month, for a total of 12 months. If randomised to receive a placebo treatment you will be given drops to take that do not contain vitamin D.

In addition to the supplements, the study will also involve:

  • A blood test

  • Various questionnaires regarding participant symptoms, mood, levels of sun exposure, skin type, levels of physical activity, and dietary intake of foods containing vitamin D

  • Body measurement tests such as your height, weight, and blood pressure

These will be repeated at the beginning of the study, and at 6 and 12 month follow up appointments.

 

Inclusion Criteria:

  • Aged between 18-45 years old including women of child-bearing age

  • Diagnosis of functional psychosis defined according to ICD-10 criteria

  • Willing to refrain from taking multivitamins or non-study Vitamin D supplements including cod liver oil

 

Exclusion Criteria:

  • Known intolerance of Vitamin D2 or D3 or known allergy to any the trial medication

 

To refer potential participants or to request further information, please contact the research team: 

Email: Marek.Czeladzki@southernhealth.nhs.uk 

Tel: 023 8047 5943