- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03101319
Role of Vitamin D Supplementation in Schizophrenia
February 10, 2024 updated by: Dr Varun S Mehta, Central Institute of Psychiatry, Ranchi, India
Role of Vitamin D Supplementation in First Episode Schizophrenia: A Double Blind Controlled Study
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
Patients diagnosed with schizophrenia as their first episode (<7 years' duration of illness) and receiving treatment from the Central Institute of Psychiatry, Ranchi will be invited for the study.
The patients will be explained about the study and the patients giving the consent for the study will be screened for vitamin D3 insufficiency/deficiency.
The patient would be selected for the study if 25 (OH) D is below 30 ng/ml and fulfils the clinical inclusion criteria.
The patient would be recalled for enrolment in the study and the socio-demographic details will be collected along with the baseline evaluation.
The patients will be randomized to either vitamin D3 or B-Complex group in a 1:1 proportion.
Both the groups would be matched for age and gender as these may affect clinical outcome of schizophrenia and will balance the unknown confounding factors.
The randomization scheme will utilize computer-generated random numbers that will be available with the PI who will supervise the dispensing the medication, the research assistant will be blind to the randomization numbers.
This scheme will be stored in a password-protected computer and password-protected file.
Only PI will have access to this file.
The file will be opened only if a participant reports serious side effects.
The double-blind design will be continued through the study period.
The medications will be stored at room temperature and the investigators will supervise the dispensing of the study medication to subjects and/or their caregivers.
Patients randomized to vitamin D3 arm will receive 4 tablets (containing 60,000 IU vitamin D3) on the first day of visit and after the fourth week (visit 3) respectively to be taken by mouth on fixed days every week.
This dose is the recommended regimen by International Endrocrinological Society.
The subjects will receive either vitamin D3 or B Complex weekly for 08 weeks along with the antipsychotic medications as determined by the treating team.
The treating team will be encouraged to maintain stable doses if feasible.
After the duration of 08 weeks, the dosage of vitamin D3 will be continued as per the serum levels and the recommendation guidelines whereas the antipsychotic medications will be continued as per the clinical response and decision of the treating team.
Study Type
Interventional
Enrollment (Actual)
73
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Jharkhand
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Ranchi, Jharkhand, India, 834006
- Central Institute of Psychiatry
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
16 years to 48 years (Adult)
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Antipsychotic and Vitamin D3
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
|
As mentioned in the description of the study arm
|
Placebo Comparator: Antipsychotic and B Complex
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
|
As mentioned in the description of the study arm
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in the symptom dimensions of schizophrenia
Time Frame: 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.
|
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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Clinical Improvement
Time Frame: The assessment would be done at the end of 4 weeks and 8 weeks respectively after receiving the study medication.
|
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.
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Side effects
Time Frame: 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.
|
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.
|
Blood levels of serum 25 (OH) D, calcium & phosphorous
Time Frame: The blood would be drawn for assessment at the end of 8 weeks after receiving the study medications
|
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
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Varun S Mehta, MD, Central Institute of Psychiatry
- Study Chair: 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 record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
April 8, 2019
Primary Completion (Actual)
May 22, 2021
Study Completion (Actual)
June 22, 2021
Study Registration Dates
First Submitted
March 29, 2017
First Submitted That Met QC Criteria
March 29, 2017
First Posted (Actual)
April 5, 2017
Study Record Updates
Last Update Posted (Actual)
February 13, 2024
Last Update Submitted That Met QC Criteria
February 10, 2024
Last Verified
February 1, 2024
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 1D43TW009114 (U.S. NIH Grant/Contract)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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