Skip to main content
MedPath Trial logoMedPath TrialMedPath Trial Home
Clinical Trials/NCT01169142
NCT01169142CompletedPhase 4

A Pilot Study of Vitamin D Supplementation in Bronx Psychiatric Patients

Bronx Psychiatric Center1 site in 1 country40 target enrollmentStarted: January 1, 2010Last updated:
Share to TwitterShare to FacebookShare to LinkedInShare to Reddit
Conditions
Interventions

Trial Snapshot

Phase
Phase 4
Status
Completed
Enrollment
40
Locations
1
Primary Endpoint
Psychopathology as measured by the PANSS
Study OverviewStudy DesignEligibility CriteriaArms & InterventionsOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
None

Eligibility Criteria

Ages
19 Years to 70 Years (Adult, Older Adult)
Sex
All
Accepts 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

Arms & Interventions

Immediate Vitamin D3

Active Comparator

Will start Vitamin D3 immediately

Intervention: Vitamin D3 (Dietary Supplement)

Three month delay

Active Comparator

Half the subjects will be delayed three months (but evaluated) before getting Vitamin D3. (If the level is very low they will start immediately)

Intervention: Vitamin D3 (Dietary Supplement)

Outcomes

Primary Outcomes

Psychopathology as measured by the PANSS

Time Frame: 3 months

PANSS is being done every month

Secondary Outcomes

  • movement disorder(three months)
  • General Health(three months)

Investigators

Sponsor Class
Other Gov
Responsible Party
Principal Investigator
Principal Investigator

Nigel Bark MD

Director of Scizhophrenia Research

Bronx Psychiatric Center

Study Sites (1)

Loading locations...

Similar Trials

Completed
Not Applicable
Vitamin D Supplementation for Bipolar DepressionBipolar DepressionBipolar Disorder
NCT01884844University of Massachusetts, Worcester33
Completed
Phase 4
Vitamin D Supplementation and Regulatory FoxP3+ T Cells in the GUTImmune Tolerance
NCT01538485Medical University of Graz16
Completed
Not Applicable
The Effect of Vitamin D Administration to Premature Infants on Vitamin D Status and Respiratory MorbidityOther Preterm InfantsBronchiolitisVitamin D DeficiencyPneumoniaAsthma
NCT02404623Soroka University Medical Center50
Unknown
Not Applicable
Vitamin D Supplementation in the Armed ForcesInjuryStress Fracture
NCT03963128University of Surrey4,450
Completed
Not Applicable
Effectiveness of High Dose Vitamin D Supplementation in Stage III Colorectal CancerRectal CancerColon Cancer
NCT02603757Legacy Health System70