Study of Vitamin D in the Severely Mentally Ill

Bronx Psychiatric Center40 enrolled

Overview

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

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Schizophrenia Schizoaffective Disorder

Interventions

Vitamin D3DIETARY_SUPPLEMENT

50,000 units of Vitamin D3 weekly

Vitamin D3DIETARY_SUPPLEMENT

Vitamin D3 50,000 units weekly

Eligibility

Sex: ALLMin age: 19 YearsMax age: 70 Years

Medical Language ↔ Plain English

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

Locations (1)

Bronx Psychiatric Center

The Bronx, New York, United States

Outcomes

Primary Outcomes

Psychopathology as measured by the PANSS

PANSS is being done every month

Time frame: 3 months

Secondary Outcomes

movement disorder

AIMS (for tardive dyskinesia), Simpson-Angus (for Parkinsonism) and Barnes (for Akathisia) movement disorder rating scales will be completed monthly.

Time frame: three months

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

Time frame: three months

Data from ClinicalTrials.gov

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