Schizophrenia Clinical Trial
Official title:
Role of Vitamin D Supplementation in First Episode Schizophrenia: A Double Blind Controlled Study
Verified date | February 2024 |
Source | Central Institute of Psychiatry, Ranchi, India |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 73 |
Est. completion date | June 22, 2021 |
Est. primary completion date | May 22, 2021 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 50 Years |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
India | Central Institute of Psychiatry | Ranchi | Jharkhand |
Lead Sponsor | Collaborator |
---|---|
Central Institute of Psychiatry, Ranchi, India | Dr. Ram Manohar Lohia Hospital, University of Pittsburgh |
India,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Side effects | The Vitamin D side effect check list will be administered to assess the adverse effects associated with vitamin D supplementation. The Liverpool University Neuroleptic Side Effect Rating Scale (LUNSERS) will be used to measure the severity of the neuroleptic 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. | |
Other | Blood levels of serum 25 (OH) D, calcium & phosphorous | Blood sample will be collected early in the morning before breakfast by venipunture in a vacutainer (approx. 05 ml) for the assessments. | The blood would be drawn for assessment at the end of 8 weeks after receiving the study medications | |
Primary | 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 | Clinical Improvement | Clinical Global Impression - Improvement (CGI - I) sub domain of the scale will be used to assess the patient's global functioning after initiating the study medication. | The assessment would be done at the end of 4 weeks and 8 weeks respectively after receiving the study medication. |
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