Skip to content

Study of Vitamin D in the Severely Mentally Ill

A Pilot Study of Vitamin D Supplementation in Bronx Psychiatric Patients

Status
Completed
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01169142
Enrollment
40
Registered
2010-07-26
Start date
2010-01-31
Completion date
2015-12-31
Last updated
2018-07-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Schizoaffective Disorder, Schizophrenia

Keywords

Vitamin D, Schizophrenia, Severely Mentally Ill

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.

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.

Interventions

DIETARY_SUPPLEMENTVitamin D3

50,000 units of Vitamin D3 weekly

Sponsors

Bronx Psychiatric Center
Lead SponsorOTHER_GOV

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
19 Years to 70 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Psychopathology as measured by the PANSS3 monthsPANSS is being done every month

Secondary

MeasureTime frameDescription
movement disorderthree monthsAIMS (for tardive dyskinesia), Simpson-Angus (for Parkinsonism) and Barnes (for Akathisia) movement disorder rating scales will be completed monthly.
General Healththree monthsMeasured by staff observation and reports, Labs for example glucose mg/dL, HgbA1c %A1c, Vitamin D ng/ml, calcium mg/dL, assessed monthly

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026