Role of Vitamin D Supplementation in Schizophrenia

• Status: Active, not recruiting
• Trial end date: 2021-12-31
• Target enrollment: 0
• Participant gender: All

Summary

The treatment of schizophrenia is challenging as the existing medications improve only the positive symptoms with the limited benefit on cognitive and negative symptoms which have a large bearing on the functional outcome. Recent research has suggested the association of low level of vitamin D with schizophrenia but studies are few and marred by mixed results. Thus, we propose to evaluate the effect of weekly vitamin D3 supplementation in patients with first-episode schizophrenia through a randomised doubled blind placebo controlled design.Fifty-six participants of either sex (19 - 50 years) with schizophrenia having vitamin D insufficiency/deficiency (< 30 ng/ml) will be randomly supplemented with Vitamin D3 or placebo for 8 weeks in 1:1 pattern. The clinical treatment i.e., antipsychotic medications will be continued as usual within the two groups. Participants in both the groups will be assessed at study entry, at the end of the 04 and 08 weeks (after completing supplementation) on the Positive and Negative Syndrome Scale (PANSS), Computerized Neurocognitive Battery (CNB) & Clinical Global Improvement (CGI) subscale (CGI-I). Raters will be blind to the group assigned to participants. Side effects will be monitored at every visit. The serum levels of vitamin D will be measured at baseline and at the end of 08 weeks.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Central Institute of Psychiatry, Ranchi, India
• Collaborators: Dr. Ram Manohar Lohia Hospital; University of Pittsburgh
• Treatments: Antipsychotic Agents; Cholecalciferol; Ergocalciferols; Vitamin D; Vitamins

Criteria

Inclusion Criteria:

1. Written informed consent

2. Either sex between 19-50 years

3. First episode schizophrenia with illness (< 7 years) receiving inpatient treatment

4. Serum (25) OH D below 30 ng/ml

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