NCT01169142

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for phase_4 schizophrenia

Timeline
Completed

Started Jan 2010

Longer than P75 for phase_4 schizophrenia

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2010

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

July 21, 2010

Completed
5 days until next milestone

First Posted

Study publicly available on registry

July 26, 2010

Completed
3.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2014

Completed
1.5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2015

Completed
Last Updated

July 19, 2018

Status Verified

July 1, 2018

Enrollment Period

4.4 years

First QC Date

July 21, 2010

Last Update Submit

July 17, 2018

Conditions

SchizophreniaSchizoaffective Disorder

Keywords

Vitamin DSchizophreniaSeverely Mentally Ill

Outcome Measures

Primary Outcomes (1)

  • Psychopathology as measured by the PANSS

    PANSS is being done every month

    3 months

Secondary Outcomes (2)

  • movement disorder

    three months

  • General Health

    three months

Study Arms (2)

Immediate Vitamin D3

ACTIVE COMPARATOR

Will start Vitamin D3 immediately

Dietary Supplement: Vitamin D3

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)

Dietary Supplement: Vitamin D3

Interventions

Vitamin D3DIETARY_SUPPLEMENT

50,000 units of Vitamin D3 weekly

Also known as: Cholecalciferol
Three month delay

Eligibility Criteria

Age19 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age 19-70,
  • Schizophrenia or Schizoaffective disorder
  • stabilized but not expecting to be discharged soon
  • capacity to give informed consent

You may not qualify if:

  • acutely psychotic
  • acutely medically ill
  • renal insufficiency
  • hypercalcemia
  • hyperparathyroidism

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Bronx Psychiatric Center

The Bronx, New York, 10461, United States

Location

MeSH Terms

Conditions

SchizophreniaPsychotic Disorders

Interventions

Cholecalciferol

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic DisordersMental Disorders

Intervention Hierarchy (Ancestors)

CholestenesCholestanesSteroidsFused-Ring CompoundsPolycyclic CompoundsSterolsVitamin DSecosteroidsMembrane LipidsLipids

Study Officials

  • NIgel Bark, MD

    Bronx Psychiatric Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director of Scizhophrenia Research

Study Record Dates

First Submitted

July 21, 2010

First Posted

July 26, 2010

Study Start

January 1, 2010

Primary Completion

June 1, 2014

Study Completion

December 1, 2015

Last Updated

July 19, 2018

Record last verified: 2018-07

Locations

US(1)