Psychosis Mental and Behavioural Disorders
Conditions
Interventions
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 120,000 IU of vitamin D3, using the widely u
Sponsors
King's College London
Eligibility
Sex/Gender
All
Inclusion 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 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
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
Design outcomes
Secondary
| Measure | Time frame |
|---|---|
| Current secondary outcome measures as of 24/05/2021: 1. Psychosis symptom severity assessed using the total Positive and Negative Syndrome Scale (PANSS) at 6-month follow-up 2. Positive symptom severity assessed using the PANSS Positive Scale subscore at 3 and 6 months 3. Negative symptom severity assessed using the PANSS Negative Scale subscore at 3 and 6 months 4. Cognitive symptom severity assessed using the PANSS General Psychopathology Scale subscore at 3 and 6 months 5. Ability to function assessed using Global Assessment of Function (GAF) at 6 months 6. Depression assessed using the Calgary Depression Scale (CDS) at 6 months 7. Waist circumference (cm) at 6 months 8. Body mass index (BMI) (kg/m2) at 6 months 9. HbA1c (mmol/mol) at 6 months 10. Total cholesterol (mmol/l) at 6 months 11. C-reactive protein (CRP)(mg/l) at 6 months 12. Vitamin D (25(OH)D) concentrations at 6 months _____ Previous secondary outcome measures as of 11/10/2017: 1. Calgary Depression Scale is used at baseline and 6 months 2. GAF scale is used at baseline and six months Previous secondary outcome measures: 1. Calgary Depression Scale; Timepoint(s): 6, 12 months 2. GAF scale; Timepoint(s): 6, 12 months | — |
Primary
| Measure | Time frame |
|---|---|
| Current primary outcome measure as of 24/05/2021: Psychosis symptom severity assessed using the total Positive and Negative Syndrome Scale (PANSS) at 6-month follow-up _____ Previous primary outcome measure as of 11/10/2017: PANSS is used at baseline, 3 and 6 months. _____ Previous primary outcome measure: PANSS; Timepoint(s): 6 months, 12 months | — |
Countries
England, United Kingdom
Contacts
Public ContactGabriella Wojewodka
Outcome results
None listed