Health Condition 1: null- Diagnosed with schizophrenia as first episode
Conditions
Interventions
Intervention1: Vitamin D3: Patients randomized to vitamin D3 arm will
receive a single capsule(containing 60,000 IU vitamin D3) on the first day of visit and then every week to be taken by mouth on fi
Sponsors
Dr Varun S Mehta
Eligibility
Inclusion criteria
Inclusion criteria: 1. Written informed consent 2. First episode schizophrenia with illness ( years) receiving inpatient treatment 3.Serum (25) OH D below 30 ng/ml
Exclusion criteria
Exclusion criteria: 1. Presence of co-morbid psychiatric disorder 2. History of substance use meeting dependence criteria excluding caffeine 3. Co-morbid medical illness or medications known to affect vitamin D e.g. Hypothyroidism, Arthritis, Osteoporosis, Rickets, End Stage Renal Disease, Malabsorption Syndromes, Corticosteroid therapy 4. Patients already on Vitamin D supplementation 5. Patients with BMI more than 30kg/m² & women who have reached menopause as they have higher dietary requirements
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Change in the positive & negative symptoms of schizophrenia using the Positive and Negative Syndrome Scale (PANSS) 2. Change in the cognitive symptoms of schizophrenia using the Computerized Neurocognitive Battery (CNB)Timepoint: Both the assessments would be done at baseline followed by repeat assessments at the end of four weeks and eight weeks respectively | — |
Secondary
| Measure | Time frame |
|---|---|
| Clinical Improvement using the Clinical Global Impression - Improvement subdomainTimepoint: The assessment would be done at the end of 4 weeks and 8 weeks respectively;Vitamin D levels, Serum Calcium and phosphorusTimepoint: Since the supplementation would be continued for eight weeks, a venipuncture would be done at baseline and at the end of eight weeks to assess the levels of vitamin D, calcium and phosphorus;Side effects due to the administration of vitamin D and antipsychotic. The side effects due to Vitamin D supplementation would be measured using the Vitamin D side effect checklist and due to the antipsychotics would be measured using the Liverpool University Neuroleptic Side Effect Rating ScaleTimepoint: The assessments for the side effects would be done at baseline followed by repeat assessments at the end of four weeks and eight weeks respectively | — |
Countries
India
Contacts
Public ContactDr Varun S Mehta
Central Institute of Psychiatry
Outcome results
None listed