Study of Vitamin D in the Severely Mentally Ill

July 17, 2018 updated by: Nigel Bark MD, Bronx Psychiatric Center

A Pilot Study of Vitamin D Supplementation in Bronx Psychiatric Patients

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

40

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New York
      • Bronx, New York, United States, 10461
        • Bronx Psychiatric Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

19 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Immediate Vitamin D3
Will start Vitamin D3 immediately
Dietary supplement: Vitamin D3
50,000 units of Vitamin D3 weekly
Other Names:
  • Cholecalciferol
Dietary supplement: Vitamin D3
Vitamin D3 50,000 units weekly
Other Names:
  • 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 Names:
  • Cholecalciferol
Dietary supplement: Vitamin D3
Vitamin D3 50,000 units weekly
Other Names:
  • Cholecalciferol

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Psychopathology as measured by the PANSS
Time Frame: 3 months
PANSS is being done every month
3 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
three months
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
three months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Bronx Psychiatric Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2010

Primary Completion (Actual)

June 1, 2014

Study Completion (Actual)

December 1, 2015

Study Registration Dates

First Submitted

July 21, 2010

First Submitted That Met QC Criteria

July 23, 2010

First Posted (Estimate)

July 26, 2010

Study Record Updates

Last Update Posted (Actual)

July 19, 2018

Last Update Submitted That Met QC Criteria

July 17, 2018

Last Verified

July 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BPCIRB0804

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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