Study of Vitamin D in the Severely Mentally Ill

Schizophrenia Clinical Trial

Official title:

A Pilot Study of Vitamin D Supplementation in Bronx Psychiatric Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01169142
• Other study ID #: BPCIRB0804
• Status: Completed
• Phase: Phase 4
• Start date: January 2010
• Est. completion date: December 2015

Study information

• Verified date: July 2018
• Source: Bronx Psychiatric Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Supplementation of Vitamin D in those with low levels will increase the level and result in some improvement in health and psychopathology measures.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: December 2015
• Est. primary completion date: June 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Psychotic Disorders
• Schizoaffective Disorder
• Schizophrenia

Intervention

Dietary Supplement:
• Vitamin D3
50,000 units of Vitamin D3 weekly
• Vitamin D3
Vitamin D3 50,000 units weekly

Locations

Country	Name	City	State
United States	Bronx Psychiatric Center	Bronx	New York

Sponsors (1)

Lead Sponsor	Collaborator
Bronx Psychiatric Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Psychopathology as measured by the PANSS	PANSS is being done every month	3 months
Secondary	movement disorder	AIMS (for tardive dyskinesia), Simpson-Angus (for Parkinsonism) and Barnes (for Akathisia) movement disorder rating scales will be completed monthly.	three months
Secondary	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	three months