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Study of Vitamin D in the Severely Mentally Ill

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.
 
ClinicalTrials.gov Identifier: NCT01169142
Recruitment Status : Completed
First Posted : July 26, 2010
Last Update Posted : July 19, 2018
Sponsor:
Information provided by (Responsible Party):
Nigel Bark MD, Bronx Psychiatric Center

Tracking Information
First Submitted Date  ICMJE July 21, 2010
First Posted Date  ICMJE July 26, 2010
Last Update Posted Date July 19, 2018
Study Start Date  ICMJE January 2010
Actual Primary Completion Date June 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 23, 2010)
Psychopathology as measured by the PANSS [ Time Frame: 3 months ]
PANSS is being done every month
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: July 23, 2010)
  • 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
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Study of Vitamin D in the Severely Mentally Ill
Official Title  ICMJE A Pilot Study of Vitamin D Supplementation in Bronx Psychiatric Patients
Brief Summary Supplementation of Vitamin D in those with low levels will increase the level and result in some improvement in health and psychopathology measures.
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Schizophrenia
  • Schizoaffective Disorder
Intervention  ICMJE
  • Dietary Supplement: Vitamin D3
    50,000 units of Vitamin D3 weekly
    Other Name: Cholecalciferol
  • Dietary Supplement: Vitamin D3
    Vitamin D3 50,000 units weekly
    Other Name: Cholecalciferol
Study Arms  ICMJE
  • Active Comparator: Immediate Vitamin D3
    Will start Vitamin D3 immediately
    Intervention: Dietary Supplement: Vitamin D3
  • 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)
    Intervention: Dietary Supplement: Vitamin D3
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: April 23, 2012)
40
Original Estimated Enrollment  ICMJE
 (submitted: July 23, 2010)
20
Actual Study Completion Date  ICMJE December 2015
Actual Primary Completion Date June 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 19 Years to 70 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01169142
Other Study ID Numbers  ICMJE BPCIRB0804
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Nigel Bark MD, Bronx Psychiatric Center
Study Sponsor  ICMJE Bronx Psychiatric Center
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: NIgel Bark, MD Bronx Psychiatric Center
PRS Account Bronx Psychiatric Center
Verification Date July 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP