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Study of Vitamin D in the Severely Mentally Ill

This study is currently recruiting participants. (see Contacts and Locations)
Verified February 2013 by Bronx Psychiatric Center
Sponsor:
Information provided by (Responsible Party):
Nigel Bark MD, Bronx Psychiatric Center
ClinicalTrials.gov Identifier:
NCT01169142
First received: July 21, 2010
Last updated: February 5, 2013
Last verified: February 2013
  Purpose

Supplementation of Vitamin D in those with low levels will increase the level and result in some improvement in health and psychopathology measures.


Condition Intervention
Schizophrenia
Schizoaffective Disorder
Dietary Supplement: Vitamin D3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Pilot Study of Vitamin D Supplementation in Bronx Psychiatric Patients

Resource links provided by NLM:


Further study details as provided by Bronx Psychiatric Center:

Primary Outcome Measures:
  • Psychopathology as measured by the PANSS [ Time Frame: 3 months ] [ Designated as safety issue: No ]
    PANSS is being done every month


Secondary Outcome Measures:
  • movement disorder [ Time Frame: three months ] [ Designated as safety issue: No ]
    AIMS (for tardive dyskinesia), Simpson-Angus (for Parkinsonism) and Barnes (for Akathisia) movement disorder rating scales will be completed monthly.

  • General Health [ Time Frame: three months ] [ Designated as safety issue: Yes ]
    Measured by staff observation and reports, Labs for example glucose mg/dL, HgbA1c %A1c, Vitamin D ng/ml, calcium mg/dL, assessed monthly


Estimated Enrollment: 40
Study Start Date: January 2010
Estimated Study Completion Date: December 2013
Estimated Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Immediate Vitamin D3
Will start Vitamin D3 immediately
Dietary Supplement: Vitamin D3
Vitamin D3 50,000 units weekly
Other Name: Cholecalciferol
Active Comparator: Three month delay
Half the subjects will be delayed three months (but evaluated) before getting Vitamin D3. (If the level is very low they will start immediately)
Dietary Supplement: Vitamin D3
50,000 units of Vitamin D3 weekly
Other Name: Cholecalciferol

Detailed Description:

Subjects with levels of Vitamin D between 7ng/ml and 30ng/ml will, after signing consent forms, be randomly assigned to either start immediately on Vitamin D for three months or to start after a delay of three months. Those with levels below 7gn/ml will start immediately. All will be evaluated monthly with blood tests, PANSS, movement disorder ratings and information on health and progress from the clinical chart.

  Eligibility

Ages Eligible for Study:   19 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Age 19-70,
  • Schizophrenia or Schizoaffective disorder
  • stabilized but not expecting to be discharged soon
  • capacity to give informed consent

Exclusion Criteria:

  • acutely psychotic
  • acutely medically ill
  • renal insufficiency
  • hypercalcemia
  • hyperparathyroidism
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01169142

Contacts
Contact: Nigel Bark, MD 7188625429 Nigel.Bark@omh.ny.gov

Locations
United States, New York
Bronx Psychiatric Center Recruiting
Bronx, New York, United States, 10461
Principal Investigator: Nigel Bark, MD         
Sponsors and Collaborators
Bronx Psychiatric Center
Investigators
Principal Investigator: NIgel Bark, MD Bronx Psychiatric Center
  More Information

No publications provided

Responsible Party: Nigel Bark MD, Director of Scizhophrenia Research, Bronx Psychiatric Center
ClinicalTrials.gov Identifier: NCT01169142     History of Changes
Other Study ID Numbers: BPCIRB0804
Study First Received: July 21, 2010
Last Updated: February 5, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Bronx Psychiatric Center:
Vitamin D
Schizophrenia
Severely Mentally Ill

Additional relevant MeSH terms:
Psychotic Disorders
Schizophrenia
Mental Disorders
Schizophrenia and Disorders with Psychotic Features
Cholecalciferol
Ergocalciferols
Vitamin D
Vitamins
Bone Density Conservation Agents
Growth Substances
Micronutrients
Pharmacologic Actions
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on November 20, 2014