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Trial record 48 of 3313 for:    schizophrenia

Role of Vitamin D Supplementation in Schizophrenia

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ClinicalTrials.gov Identifier: NCT03101319
Recruitment Status : Not yet recruiting
First Posted : April 5, 2017
Last Update Posted : October 3, 2017
Sponsor:
Collaborators:
University of Pittsburgh
Dr. Ram Manohar Lohia Hospital
Information provided by (Responsible Party):
Dr Varun S Mehta, Central Institute of Psychiatry, Ranchi, India

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.

Condition or disease Intervention/treatment Phase
Schizophrenia Drug: Vitamin D3 cholecalciferol Drug: Placebo Oral Tablet Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 56 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Role of Vitamin D Supplementation in First Episode Schizophrenia: A Double Blind Placebo Controlled Study
Estimated Study Start Date : December 2017
Estimated Primary Completion Date : December 2019
Estimated Study Completion Date : December 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Antipsychotic and Vitamin D3
Subjects randomised to vitamin D3 arm will receive a capsule 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
As mentioned in the description of the study arm
Other Name: NeuroD3K

Placebo Comparator: Antipsychotic and Placebo
Subjects randomised to the placebo arm will receive a capsule 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: Placebo Oral Tablet
As mentioned in the description of the study arm
Other Name: Placebo for Vitamin D3




Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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.


Other Outcome Measures:
  1. 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

  2. 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.



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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03101319


Contacts
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Contact: Varun S Mehta, MD (+91)9204858189 vs_mehta@yahoo.co.in

Sponsors and Collaborators
Central Institute of Psychiatry, Ranchi, India
University of Pittsburgh
Dr. Ram Manohar Lohia Hospital
Investigators
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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

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Responsible Party: Dr Varun S Mehta, Assistant Professor of Psychiatry, Central Institute of Psychiatry, Ranchi, India
ClinicalTrials.gov Identifier: NCT03101319     History of Changes
Other Study ID Numbers: 1D43TW009114 ( U.S. NIH Grant/Contract )
First Posted: April 5, 2017    Key Record Dates
Last Update Posted: October 3, 2017
Last Verified: September 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Schizophrenia
Schizophrenia Spectrum and Other Psychotic Disorders
Mental Disorders
Vitamin D
Ergocalciferols
Cholecalciferol
Vitamins
Antipsychotic Agents
Micronutrients
Nutrients
Growth Substances
Physiological Effects of Drugs
Bone Density Conservation Agents
Calcium-Regulating Hormones and Agents
Tranquilizing Agents
Central Nervous System Depressants
Psychotropic Drugs