Role of Vitamin D Supplementation in Schizophrenia
Status:
Active, not recruiting
Trial end date:
2021-12-31
Target enrollment:
Participant gender:
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
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