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Study of Vitamin D in the Severely Mentally Ill

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified July 2015 by Nigel Bark MD, Bronx Psychiatric Center.
Recruitment status was:  Active, not recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT01169142
First Posted: July 26, 2010
Last Update Posted: July 21, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Nigel Bark MD, Bronx Psychiatric Center
  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: None (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 Nigel Bark MD, Bronx Psychiatric Center:

Primary Outcome Measures:
  • Psychopathology as measured by the PANSS [ Time Frame: 3 months ]
    PANSS is being done every month


Secondary Outcome Measures:
  • movement disorder [ Time Frame: three months ]
    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 ]
    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 2015
Primary Completion Date: June 2014 (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

Information from the National Library of Medicine

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Ages Eligible for Study:   19 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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
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): NCT01169142


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

Responsible Party: Nigel Bark MD, Director of Scizhophrenia Research, Bronx Psychiatric Center
ClinicalTrials.gov Identifier: NCT01169142     History of Changes
Other Study ID Numbers: BPCIRB0804
First Submitted: July 21, 2010
First Posted: July 26, 2010
Last Update Posted: July 21, 2015
Last Verified: July 2015

Keywords provided by Nigel Bark MD, Bronx Psychiatric Center:
Vitamin D
Schizophrenia
Severely Mentally Ill

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