SchizophreniaNCT03101319
Role of Vitamin D Supplementation in Schizophrenia
A study testing Vitamin D3 cholecalciferol and B Complex Oral Tablet in people with Schizophrenia, run by Central Institute of Psychiatry, Ranchi, India at 1 site in India.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 50 years
- Conditions the study is for
- Schizophrenia
- What is being tested?
- Vitamin D3 cholecalciferol and B Complex Oral Tablet
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 73 participants
- Where
- 1 siteIndia
- Study dates
- 8 Apr 2019to 22 Jun 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Schizophrenia
- Being tested
- Vitamin D3 cholecalciferol, B Complex Oral Tablet
- Medical subject headings
- Schizophrenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vitamin D3 cholecalciferolDrug
As mentioned in the description of the study arm
B Complex Oral TabletDrug
As mentioned in the description of the study arm
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 Receives: Drug: B Complex Oral Tablet |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
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.
Measured: The assessment would be done at the end of 4 weeks and 8 weeks respectively after receiving the study medication.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Apr 2017
- Study start8 Apr 2019
- Primary completion22 May 2021
- Study completion22 Jun 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SchizophreniaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 73 participants (actual)
Sponsor and investigators
- Lead sponsor
- Central Institute of Psychiatry, Ranchi, India
- Sponsor type
- University, hospital or other
- Collaborators
- University of Pittsburgh, Dr. Ram Manohar Lohia Hospital
- Responsible party
- Principal investigator, Dr Varun S Mehta, Central Institute of Psychiatry, Ranchi, India
- Investigators
- Varun S Mehta, MD, Principal investigator, Central Institute of PsychiatryD Ram, MD, Study chair, Central Institute of PsychiatrySmita Deshpande, MD, Study chair, Dr. Ram Manohar Lohia Hospital, and Post Graduate Institute of Medical Education and ResearchTriptish Bhatia, PhD, Study chair, Dr. Ram Manohar Lohia Hospital, and Post Graduate Institute of Medical Education and ResearchVishwajit L Nimgaonkar, MD, Study chair, University of Pittsburgh
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03101319
- Sponsor's protocol ID
- 1D43TW009114
- Status last verified
- Feb 2024
- First submitted
- 29 Mar 2017
- Last updated
- 13 Feb 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Role of Vitamin D Supplementation in First Episode Schizophrenia: A Double Blind Controlled Study
- ClinicalTrials.gov ID
- NCT03101319
- Acronym / sponsor ID
- 1D43TW009114
- Conditions
- Schizophrenia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 73 participants (actual)
- Lead sponsor
- Central Institute of Psychiatry, Ranchi, IndiaUniversity, hospital or other
- Collaborators
- University of Pittsburgh, Dr. Ram Manohar Lohia Hospital
- Study start
- 8 Apr 2019 (actual)
- Primary completion
- 22 May 2021 (actual)
- Study completion
- 22 Jun 2021 (actual)
- First posted
- 5 Apr 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Antipsychotic and Vitamin D3 | Experimental | Drug: Vitamin D3 cholecalciferolSubjects 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 |
| Antipsychotic and B Complex | Placebo comparator | Drug: B Complex Oral TabletSubjects 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 |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Vitamin D3 cholecalciferolAs mentioned in the description of the study arm | Drug | Antipsychotic and Vitamin D3 |
| B Complex Oral TabletAs mentioned in the description of the study arm | Drug | Antipsychotic and B Complex |
Primary outcome
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
1 secondary outcome
Clinical Improvement
Time frame: The assessment would be done at the end of 4 weeks and 8 weeks respectively after receiving the study medication.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Feb 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Varun S Mehta, MD principal investigator
Central Institute of Psychiatry
D Ram, MD study chair
Central Institute of Psychiatry
Smita Deshpande, MD study chair
Dr. Ram Manohar Lohia Hospital, and Post Graduate Institute of Medical Education and Research
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Vitamin D3 cholecalciferol and B Complex Oral Tablet in people with Schizophrenia, run by Central Institute of Psychiatry, Ranchi, India at 1 site in India.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in India. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Feb 2024; AzTrials last refreshed its copy on 7 Nov 2026.