Vitamin D supplementation compared to placebo in people presenting with their first episode of psychosis neuroprotection desig

Phase 2

Completed

• Conditions: Psychosis; Mental and Behavioural Disorders

• Registration Number: ISRCTN12424842
• Lead Sponsor: King's College London

Brief Summary

2020 Protocol article in https://www.ncbi.nlm.nih.gov/pubmed/31907006 protocol (added 08/01/2020) 2021 Results article in https://pubmed.ncbi.nlm.nih.gov/34962559/ (added 30/12/2021)

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2015-02-25
• Study Completion: 2019-12-20
• Last Update Posted: 10 January 2022

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 149

Inclusion Criteria

Current inclusion criteria as of 11/10/2017:
1. Aged between 18-65 years including women of child-bearing age
2. Diagnosis of functional psychosis defined according to ICD-10 criteria
3. Willing to refrain from taking multivitamins or non-study vitamin D supplements (including cod liver oil), that exceed 400IU/day of vitamin D throughout the study
4. Patients who are willing to give a vitamin D blood sample
5. Patients who are able to and have given written informed consent

Previous 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.

Exclusion Criteria

Current exclusion criteria as of 11/10/2017:
1. Known intolerance of Vitamin D2 or D3 or known allergy to any of the trial medications
2. Those who are currently taking vitamin D supplements at a dose exceeding 400IU/day.
3. Those who have taken cardiac glycosides; calcium channel blockers; or oral, intramuscular, or intravenous corticosteroids;, bendroflumethiazide; isoniazid, or rifampicin in the past one month
4. Known active tuberculosis, sarcoidosis, hypo or hyperparathyroidism, past or present nephrolithiasis (renal stones), suspected or diagnosed hepatic or renal dysfunction, any malignancy other than non-melanoma skin cancer not in remission for = 3 years, calcium disorders
5. Baseline corrected serum calcium > 2.6mmol/L
6. Patients with known history of hypercalcaemia
7. Pregnant or breast-feeding women and women planning a pregnancy
8. Patients lacking the capacity to provide written informed consent

Previous 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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<br> Current primary outcome measure as of 24/05/2021:<br> Psychosis symptom severity assessed using the total Positive and Negative Syndrome Scale (PANSS) at 6-month follow-up<br> _____<br><br> Previous primary outcome measure as of 11/10/2017:<br> PANSS is used at baseline, 3 and 6 months.<br><br> _____<br><br> Previous primary outcome measure:<br> PANSS; Timepoint(s): 6 months, 12 months<br>