Study of Vitamin D in the Severely Mentally Ill

NCT ID: NCT01169142

Last Updated: 2018-07-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-01-31

Study Completion Date

2015-12-31

Brief Summary

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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

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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.

Conditions

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Schizophrenia Schizoaffective Disorder

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Immediate Vitamin D3

Will start Vitamin D3 immediately

Group Type ACTIVE_COMPARATOR

Vitamin D3

Intervention Type DIETARY_SUPPLEMENT

Vitamin D3 50,000 units weekly

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)

Group Type ACTIVE_COMPARATOR

Vitamin D3

Intervention Type DIETARY_SUPPLEMENT

50,000 units of Vitamin D3 weekly

Interventions

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Vitamin D3

50,000 units of Vitamin D3 weekly

Intervention Type DIETARY_SUPPLEMENT

Vitamin D3

Vitamin D3 50,000 units weekly

Intervention Type DIETARY_SUPPLEMENT

Other Intervention Names

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Cholecalciferol Cholecalciferol

Eligibility Criteria

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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
Minimum Eligible Age

19 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Bronx Psychiatric Center

OTHER_GOV

Sponsor Role lead

Responsible Party

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Nigel Bark MD

Director of Scizhophrenia Research

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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NIgel Bark, MD

Role: PRINCIPAL_INVESTIGATOR

Bronx Psychiatric Center

Locations

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Bronx Psychiatric Center

The Bronx, New York, United States

Site Status

Countries

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United States

Other Identifiers

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BPCIRB0804

Identifier Type: -

Identifier Source: org_study_id

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