Role of Vitamin D Supplementation in Schizophrenia

NCT03101319 | Completed DMC

• 1 other identifier: 1D43TW009114
• Study Type: interventional
• Target: 73
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (1)

• Change in the symptom dimensions of schizophrenia

  The outcome would be assessed as a change in the positive symptoms, negative symptoms and cognitive symptoms of schizophrenia. The Positive and Negative Syndrome Scale (PANSS) would be used to evaluate the change in the positive symptoms and the negative symptoms. The Computerized Neurocognitive Battery (CNB) would be used to assess the change in the cognitive symptoms of schizophrenia

  Both the assessments (PANSS & CNB) would be done at baseline (at study entry) and repeated at the end of 4 weeks and 8 weeks respectively after receiving the study medication.

Secondary Outcomes (1)

• Clinical Improvement

  The assessment would be done at the end of 4 weeks and 8 weeks respectively after receiving the study medication.

Other Outcomes (2)

• Side effects

  Both the assessments would be done at baseline (at study entry) and repeated at the end of 4 weeks and 8 weeks respectively after receiving the study medication.

• Blood levels of serum 25 (OH) D, calcium & phosphorous

  The blood would be drawn for assessment at the end of 8 weeks after receiving the study medications

Study Arms (2)

Antipsychotic and Vitamin D3

EXPERIMENTAL

Subjects randomised to vitamin D3 arm will receive a tablet containing 60,000 IU vitamin D3 starting from the first day of visit and then be taken by mouth on fixed days every week amounting to a total duration of 08 weeks. The subjects will continue to receive antipsychotics as per the decision of the treating team

Drug: Vitamin D3 cholecalciferol

Antipsychotic and B Complex

PLACEBO COMPARATOR

Subjects randomised to the B Complex arm will receive a tablet of identical size, shape, colour and weight starting from the first day of visit and then be taken by mouth on fixed days every week amounting to a total duration of 08 weeks. The subjects will continue to receive antipsychotics as per the decision of the treating team

Drug: B Complex Oral Tablet

Interventions

Vitamin D3 cholecalciferol DRUG

As mentioned in the description of the study arm

Antipsychotic and Vitamin D3

B Complex Oral Tablet DRUG

As mentioned in the description of the study arm

Antipsychotic and B Complex

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Written informed consent
• Either sex between 19-50 years
• First episode schizophrenia with illness (\< 7 years) receiving inpatient treatment
• Serum (25) OH D below 30 ng/ml

You may not qualify if:

• Presence of co-morbid psychiatric disorder
• History of substance use meeting dependence criteria excluding caffeine
• 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
• Patients already on Vitamin D supplementation
• Patients with BMI more than 30kg/m² \& women who have reached menopause as they have higher dietary requirements

Sponsors & Collaborators

• Central Institute of Psychiatry, Ranchi, India: lead
• University of Pittsburgh: collaborator
• Dr. Ram Manohar Lohia Hospital: collaborator

Study Sites (1)

Central Institute of Psychiatry

Ranchi, Jharkhand, 834006, India

Location

MeSH Terms

Conditions

Schizophrenia

Interventions

Cholecalciferol; Hydroquinones

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Cholestenes; Cholestanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Sterols; Vitamin D; Secosteroids; Membrane Lipids; Lipids; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals

Study Officials

• Varun S Mehta, MD

  Central Institute of Psychiatry

  PRINCIPAL INVESTIGATOR

• D Ram, MD

  Central Institute of Psychiatry

  STUDY CHAIR

• Smita Deshpande, MD

  Dr. Ram Manohar Lohia Hospital, and Post Graduate Institute of Medical Education and Research

  STUDY CHAIR

• Triptish Bhatia, PhD

  Dr. Ram Manohar Lohia Hospital, and Post Graduate Institute of Medical Education and Research

  STUDY CHAIR

• Vishwajit L Nimgaonkar, MD

  University of Pittsburgh

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Psychiatry

Study Record Dates

• First Submitted: March 29, 2017
• First Posted: April 5, 2017
• Study Start: April 8, 2019
• Primary Completion: May 22, 2021
• Study Completion: June 22, 2021
• Last Updated: February 13, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share

Locations

IN (1)