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Completed

NCT Number: NCT01169142

Study of Vitamin D in the Severely Mentally Ill

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

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Key information

Conditions

Schizophrenia Mental Disorders Psychotic Disorders Schizoaffective Disorder Schizophrenia Spectrum and Other Psychotic Disorders

Age range

19 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Bronx Psychiatric Center

The Bronx, New York, 10461, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Vitamin D3

Dietary Supplement

50,000 units of Vitamin D3 weekly

Other names: Cholecalciferol

Primary outcomes

  1. Psychopathology as measured by the PANSS

    Time frame: 3 months

    PANSS is being done every month

Secondary outcomes

  1. 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.

  2. 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

Sponsors and collaborators

Lead sponsor

Bronx Psychiatric Center

Other Gov

Registry information

Official study title

A Pilot Study of Vitamin D Supplementation in Bronx Psychiatric Patients

Important dates

Study start
2010
Primary completion
2014
Study completion
2015
First posted
Jul 26, 2010
Registry last updated
Jul 19, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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