ISRCTN12424842
Completed
Phase 2
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
Overview
- Phase
- Phase 2
- Intervention
- Not specified
- Conditions
- Psychosis
- Sponsor
- King's College London
- Enrollment
- 149
- Status
- Completed
- Last Updated
- 4 years ago
Overview
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)
Investigators
Eligibility Criteria
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
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:
Outcomes
Primary Outcomes
Not specified
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