Role of Vitamin D Supplementation in Schizophrenia

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.

Conditions

• Schizophrenia

Interventions

DRUG

Vitamin D3 cholecalciferol

As mentioned in the description of the study arm

DRUG

B Complex Oral Tablet

As mentioned in the description of the study arm

Sponsors & Collaborators

• University of Pittsburgh

  collaborator OTHER

• Dr. Ram Manohar Lohia Hospital

  collaborator OTHER_GOV

• Central Institute of Psychiatry, Ranchi, India

  lead OTHER

Principal Investigators

• Varun S Mehta, MD · Central Institute of Psychiatry

• D Ram, MD · Central Institute of Psychiatry

• Smita Deshpande, MD · Dr. Ram Manohar Lohia Hospital, and Post Graduate Institute of Medical Education and Research

• Triptish Bhatia, PhD · Dr. Ram Manohar Lohia Hospital, and Post Graduate Institute of Medical Education and Research

• Vishwajit L Nimgaonkar, MD · University of Pittsburgh

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

50 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2019-04-08

Primary Completion

2021-05-22

Completion

2021-06-22

Countries

• India

Study Locations