Study of Vitamin D in the Severely Mentally Ill

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

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.

Condition or disease	Intervention/treatment	Phase
Schizophrenia; Schizoaffective Disorder	Dietary Supplement: Vitamin D3	Phase 4

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 Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 40 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: A Pilot Study of Vitamin D Supplementation in Bronx Psychiatric Patients
• Study Start Date: January 2010
• Actual Primary Completion Date: June 2014
• Actual Study Completion Date: December 2015

Arms and Interventions

Arm	Intervention/treatment
Active Comparator: Immediate Vitamin D3; Will start Vitamin D3 immediately	Dietary Supplement: Vitamin D3; Vitamin D3 50,000 units weekly; Other Name: Cholecalciferol
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)	Dietary Supplement: Vitamin D3; 50,000 units of Vitamin D3 weekly; Other Name: Cholecalciferol

Outcome Measures

Primary Outcome Measures :

1. Psychopathology as measured by the PANSS [ Time Frame: 3 months ]
   PANSS is being done every month

Secondary Outcome Measures :

1. 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.
2. 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

Eligibility Criteria

• Ages Eligible for Study: 19 Years to 70 Years (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

United States, New York

Bronx Psychiatric Center

Bronx, New York, United States, 10461

Sponsors and Collaborators

Bronx Psychiatric Center

Investigators

• Principal Investigator: NIgel Bark, MD; Bronx Psychiatric Center

More Information

• Responsible Party: Nigel Bark MD, Director of Scizhophrenia Research, Bronx Psychiatric Center
• ClinicalTrials.gov Identifier: NCT01169142
• Other Study ID Numbers: BPCIRB0804
• First Posted: July 26, 2010
• Last Update Posted: July 19, 2018
• Last Verified: July 2018

Keywords provided by Nigel Bark MD, Bronx Psychiatric Center:

Vitamin D; Schizophrenia; Severely Mentally Ill

Additional relevant MeSH terms:

Schizophrenia; Psychotic Disorders; Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders; Vitamin D; Ergocalciferols; Cholecalciferol; Vitamins; Micronutrients; Physiological Effects of Drugs; Bone Density Conservation Agents; Calcium-Regulating Hormones and Agents