Text Size

Study of Vitamin D in the Severely Mentally Ill

This study is currently recruiting participants.
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
History of Changes
  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:

U.S. FDA Resources

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

ClinicalTrials.gov processed this record on May 16, 2013