Role of Vitamin D Supplementation in Schizophrenia
Condition: Schizophrenia
MeSH terms: Schizophrenia
Study type: Interventional

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.
    

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.
    

Intervention name(s): Vitamin D3 cholecalciferol; B Complex Oral Tablet
Intervention type(s): Drug; Drug
Intervention description(s): As mentioned in the description of the study arm; As mentioned in the description of the study arm
Intervention MeSH terms: Vitamin D; Cholecalciferol
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment