Study of Vitamin D in the Severely Mentally Ill

Phase 4

Completed

• Conditions: Schizophrenia; Schizoaffective Disorder

• Registration Number: NCT01169142
• Lead Sponsor: Bronx Psychiatric Center

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 Timeline

• Study Start: 2010-01
• Study First Submitted: 2010-07-21
• Study First Submitted QC: 2010-07-23
• Study First Posted: 2010-07-26
• Primary Completion: 2014-06
• Study Completion: 2015-12
• Status Verified: 2018-07
• Last Update Submitted: 2018-07-17
• Last Update Posted: 2018-07-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Psychopathology as measured by the PANSS	3 months	PANSS is being done every month

Secondary Outcome Measures

Name	Time	Method
movement disorder	three months	AIMS (for tardive dyskinesia), Simpson-Angus (for Parkinsonism) and Barnes (for Akathisia) movement disorder rating scales will be completed monthly.
General Health	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

Trial Locations

Locations (1)

Bronx Psychiatric Center; 🇺🇸 Bronx, New York, United States