Back to resultsStudy of Vitamin D in the Severely Mentally Ill
Primary Purpose
Schizophrenia, Schizoaffective Disorder
Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Vitamin D3
Vitamin D3
Sponsored by
About this trial
This is an interventional treatment trial for Schizophrenia focused on measuring Vitamin D, Schizophrenia, Severely Mentally Ill
Eligibility 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
Sites / Locations
- Bronx Psychiatric Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Immediate Vitamin D3
Three month delay
Arm Description
Will start Vitamin D3 immediately
Half the subjects will be delayed three months (but evaluated) before getting Vitamin D3. (If the level is very low they will start immediately)
Outcomes
Primary Outcome Measures
Psychopathology as measured by the PANSS
PANSS is being done every month
Secondary Outcome Measures
movement disorder
AIMS (for tardive dyskinesia), Simpson-Angus (for Parkinsonism) and Barnes (for Akathisia) movement disorder rating scales will be completed monthly.
General Health
Measured by staff observation and reports, Labs for example glucose mg/dL, HgbA1c %A1c, Vitamin D ng/ml, calcium mg/dL, assessed monthly
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01169142
Brief Title
Study of Vitamin D in the Severely Mentally Ill
Official Title
A Pilot Study of Vitamin D Supplementation in Bronx Psychiatric Patients
Study Type
Interventional
2. Study Status
Record Verification Date
July 2018
Overall Recruitment Status
Completed
Study Start Date
January 2010 (undefined)
Primary Completion Date
June 2014 (Actual)
Study Completion Date
December 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Bronx Psychiatric Center
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Schizophrenia, Schizoaffective Disorder
Keywords
Vitamin D, Schizophrenia, Severely Mentally Ill
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
40 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Immediate Vitamin D3
Arm Type
Active Comparator
Arm Description
Will start Vitamin D3 immediately
Arm Title
Three month delay
Arm Type
Active Comparator
Arm Description
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 Type
Dietary Supplement
Intervention Name(s)
Vitamin D3
Other Intervention Name(s)
Cholecalciferol
Intervention Description
50,000 units of Vitamin D3 weekly
Intervention Type
Dietary Supplement
Intervention Name(s)
Vitamin D3
Other Intervention Name(s)
Cholecalciferol
Intervention Description
Vitamin D3 50,000 units weekly
Primary Outcome Measure Information:
Title
Psychopathology as measured by the PANSS
Description
PANSS is being done every month
Time Frame
3 months
Secondary Outcome Measure Information:
Title
movement disorder
Description
AIMS (for tardive dyskinesia), Simpson-Angus (for Parkinsonism) and Barnes (for Akathisia) movement disorder rating scales will be completed monthly.
Time Frame
three months
Title
General Health
Description
Measured by staff observation and reports, Labs for example glucose mg/dL, HgbA1c %A1c, Vitamin D ng/ml, calcium mg/dL, assessed monthly
Time Frame
three months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
19 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
NIgel Bark, MD
Organizational Affiliation
Bronx Psychiatric Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Bronx Psychiatric Center
City
Bronx
State/Province
New York
ZIP/Postal Code
10461
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Study of Vitamin D in the Severely Mentally Ill
We'll reach out to this number within 24 hrs