Condition category
Mental and Behavioural Disorders
Date applied
Date assigned
Last edited
Prospectively registered
Overall trial status
Recruitment status

Plain English Summary

Background and study aims
Vitamin D is commonly known as the “sunshine hormone” – if your skin is regularly exposed to sunlight, it makes enough vitamin D to keep your body healthy. However, people living in the UK commonly have low vitamin D, because of our lack of strong sunshine. While vitamin D is known to be important for bone health, there is growing evidence that it may also help people recover from various brain diseases. In other words, having enough vitamin D may protect the brain (i.e. it could be ‘neuroprotective’). At this stage, there is a lack of evidence to clarify if adding vitamin D to the standard treatment of people recovering from their first episode of a psychotic disorder can help recovery. The best way to examine this question is with a Randomized Controlled Trial (RCT). To do this we need to compare vitamin D supplements to placebo. A computer program decides which group you are allocated to, so there is an equal chance (50:50) that you will be allocated to either of the two groups. The results are compared to see if one is better. In a ‘blind trial’ you will not know which treatment group you are in. This trial is ‘double blind trial‘, meaning that neither you nor the study team will know in which treatment group you are. If adding vitamin D supplements to standard treatment can help people make a better recovery, then in the future we will be able to provide this type of treatment routinely The Vitamin D (or placebo) supplement will be given to you once a month by a clinician, alongside the regular treatment that you receive from your mental health team. The aim of this study is to explore if the addition of a vitamin D supplement to standard treatments (which may include medications, general support and talking therapies) can help people recover after having their first episode of a psychotic disorder. To do this, we will compare a group of people who are receiving a vitamin D supplement as well as their standard treatment versus those who receive a placebo supplement (dummy supplement that contains no vitamin D) and standard treatment alone.

What does the study involve
Study participants are recruited from Early Intervention in Psychosis Services. Participation in the study is entirely voluntary. Half of the participants who join the study are randomly allocated to receiving the vitamin D supplement while half receive a ‘placebo’ treatment (an identical looking treatment but without vitamin D). Each participant is asked to take six drops (just over one teaspoon) of the vitamin D supplement (or placebo) once a month for a total of 12 months.. During their participation in the study (1 year), we ask each participant that they do not use other vitamin D supplements, either alone or as part of a multivitamin preparation. During the study, the participants take part in a number of assessments. A trained research phlebotomist takes a small sample of blood (the equivalent of a few tablespoons) from each . The purpose of the blood test is to have a measure of what each participants vitamin D levels were when they entered the study and again at the 6 and 12 month assessment points.. At the end of the study, with their permission, we will provide clinical team of each participant with their most recent Vitamin D level. From the same blood sample we will also check on each participants general blood chemistry, including calcium levels and hormones that are linked to vitamin D. Participants are also asked if they would give another blood sample for genetic testing (in many cases, genes can alter vitamin D levels). Each participant is also asked various questions about symptoms, mood, plus any side effects caused by the treatments. To monitor their physical health we ask each participants permission to measure their weight, height, waist and blood pressure measurements. We will repeat questionnaires administered at the start of the study at 6 and 12 months and will review each participants clinical notes to investigate changes over time. At 3 and 9 months we perform a blood test to check each participants calcium and hormone levels.

What are the possible benefits and risks of participating?
It is hoped that the participants will benefit from the treatment by having closer contact with the clinic. If they also receive the Vitamin D supplement then this may be good for bone and muscle health.

Where is the study run from?
South London and Maudsley NHS Foundation Trust (UK)

When is the study starting and how long is it expected to run for?
April 2015 to April 2017

Who is funding the study?
Stanley Medical Research Institute (USA)

Who is the main contact?
Ms Poonam Sood

Trial website

Contact information



Primary contact

Ms Poonam Sood


Contact details

King's College London
Institute Of Psychiatry
16 De Crespigny Park
United Kingdom

Additional identifiers

EudraCT number

2014-002639-32 number

Protocol/serial number


Study information

Scientific title

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



Study hypothesis

The aim of this study is to investigate the effects of vitamin D supplementation in people presenting with their first episode of psychosis.

Ethics approval


Study design

Randomised; Interventional; Design type: Treatment

Primary study design


Secondary study design

Randomised controlled trial

Trial setting


Trial type


Patient information sheet

Not available in web format, please use contact details to request a patient information sheet


Topic: Mental Health; Subtopic: Psychosis; Disease: Psychosis


Vitamin D3: We will use a safe and convenient monthly treatment regimen in the DFEND trial. Under the direct supervision of trial staff, we will administer 120,000IU of vitamin D3, using the widely used oral Vigantol oil preparation. This potent form of vitamin D has been used often in clinical trials, and comparable strategies are currently underway in large population based randomised controlled trials in the USA, New Zealand, Australia and the United Kingdom (total samples approx. 90,000 individuals).
Follow Up Length: 12 months
Study Entry : Single Randomisation only

Intervention type



Phase IV

Drug names

Primary outcome measures

PANSS; Timepoint(s): 6 months, 12 months

Secondary outcome measures

1. Calgary Depression Scale; Timepoint(s): 6, 12 months
2. GAF scale; Timepoint(s): 6, 12 months

Overall trial start date


Overall trial end date


Reason abandoned


Participant inclusion criteria

1. Patients experiencing their first episode of psychosis (or FEP, defined as first presentation in the last six months)
2. Attending clinical services run in the South London and Maudsley Hospital NHS Foundation Trust.
3. Aged 18-45 years
4. Must have capacity to provide written informed consent and have sufficient English language skills to complete the study
5. Subjects must agree to refrain from taking multivitamin or non-study vitamin D supplements throughout the study
6. Must be willing to provide a vitamin D blood sample at baseline

Psychosis will be defined according to ICD-10 criteria for psychosis (codes F20-29 and F3033) and confirmed with an OPCRIT (OPerational CRITeria) diagnosis.

Participant type


Age group




Target number of participants

Planned Sample Size: 240; UK Sample Size: 240; Description: 120 (50%) will be randomized to the Active Treatment arm (120,000 IU monthly of vitamin D) and 50% (n=120) to the placebo arm.

Participant exclusion criteria

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

Recruitment start date


Recruitment end date



Countries of recruitment

United Kingdom

Trial participating centre

King's College London
Institute Of Psychiatry 16 De Crespigny Park
United Kingdom

Sponsor information


King's College London

Sponsor details

Room 1.8
Hodgkin Building
Guy's Campus
United Kingdom

Sponsor type

Hospital/treatment centre



Funder type

Research organisation

Funder name

Stanley Medical Research Institute

Alternative name(s)


Funding Body Type

private sector organisation

Funding Body Subtype

other non-profit


United States of America

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes