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Study of Vitamin D in the Severely Mentally Ill

This study is ongoing, but not recruiting participants.
Information provided by (Responsible Party):
Nigel Bark MD, Bronx Psychiatric Center Identifier:
First received: July 21, 2010
Last updated: July 20, 2015
Last verified: July 2015
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
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 ]
    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.

Ages Eligible for Study:   19 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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
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Please refer to this study by its identifier: NCT01169142

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

Responsible Party: Nigel Bark MD, Director of Scizhophrenia Research, Bronx Psychiatric Center Identifier: NCT01169142     History of Changes
Other Study ID Numbers: BPCIRB0804
Study First Received: July 21, 2010
Last Updated: July 20, 2015

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

Additional relevant MeSH terms:
Psychotic Disorders
Schizophrenia Spectrum and Other Psychotic Disorders
Mental Disorders
Vitamin D
Growth Substances
Physiological Effects of Drugs
Bone Density Conservation Agents processed this record on April 21, 2017