Study of Vitamin D in the Severely Mentally Ill

Phase 4

Completed

• Conditions: Schizophrenia; Schizoaffective Disorder
• Interventions: Dietary Supplement: Vitamin D3

• 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

Arm && Interventions

Group	Intervention	Description
Three month delay	Vitamin D3	Half the subjects will be delayed three months (but evaluated) before getting Vitamin D3. (If the level is very low they will start immediately)
Immediate Vitamin D3	Vitamin D3	Will start Vitamin D3 immediately

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