This trial is active, not recruiting.

Conditions schizophrenia, schizoaffective disorder
Treatments vitamin d3
Sponsor Bronx Psychiatric Center
Start date January 2010
End date June 2014
Trial size 40 participants
Trial identifier NCT01169142, BPCIRB0804


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

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Intervention model parallel assignment
Masking open label
Primary purpose treatment
(Active Comparator)
Will start Vitamin D3 immediately
vitamin d3 Cholecalciferol
Vitamin D3 50,000 units weekly
(Active Comparator)
Half the subjects will be delayed three months (but evaluated) before getting Vitamin D3. (If the level is very low they will start immediately)
vitamin d3 Cholecalciferol
50,000 units of Vitamin D3 weekly

Primary Outcomes

Psychopathology as measured by the PANSS
time frame: 3 months

Secondary Outcomes

movement disorder
time frame: three months
General Health
time frame: three months

Eligibility Criteria

Male or female participants from 19 years up to 70 years old.

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

Additional Information

Official title A Pilot Study of Vitamin D Supplementation in Bronx Psychiatric Patients
Principal investigator NIgel Bark, MD
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.
Trial information was received from ClinicalTrials.gov and was last updated in July 2015.
Information provided to ClinicalTrials.gov by Bronx Psychiatric Center.