Study of Vitamin D in the Severely Mentally Ill

Bronx Psychiatric Center

Status and phase: Completed; Phase 4

Conditions: Schizophrenia; Schizoaffective Disorder

Treatments: Dietary Supplement: Vitamin D3

Study type: Interventional

Funder types: Other

Identifiers

NCT01169142

BPCIRB0804

Details and patient eligibility

About

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

Full 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.

Enrollment: 40 patients

Sex: All

Ages: 19 to 70 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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40 participants in 2 patient groups

Immediate Vitamin D3

Active Comparator group

Description:

Will start Vitamin D3 immediately

Treatment:

Dietary Supplement: Vitamin D3

Dietary Supplement: Vitamin D3

Three month delay

Active Comparator group

Description:

Half the subjects will be delayed three months (but evaluated) before getting Vitamin D3. (If the level is very low they will start immediately)

Treatment:

Dietary Supplement: Vitamin D3

Dietary Supplement: Vitamin D3