NCT01004354

Brief Summary

Children and adolescents with psychiatric illnesses who are treated with medications called second generation antipsychotic agents (SGA) often gain excessive weight during their treatment with these medications. This weight gain may result in the development of features of the metabolic syndrome or frank diabetes mellitus. There is no consensus on the best way to prevent these complications. The investigators' hypothesis is that daily vitamin D supplementation in these patients will result in decreased levels of the markers of metabolic syndrome with associated reduction in waist circumference.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
12

participants targeted

Target at below P25 for not_applicable obesity

Timeline
Completed

Started Jun 2009

Shorter than P25 for not_applicable obesity

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

June 1, 2009

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

October 28, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 29, 2009

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2010

Completed
1.7 years until next milestone

Results Posted

Study results publicly available

February 10, 2012

Completed
Last Updated

November 6, 2017

Status Verified

November 1, 2017

Enrollment Period

1 year

First QC Date

October 28, 2009

Results QC Date

October 17, 2011

Last Update Submit

November 1, 2017

Conditions

ObesityVitamin D DeficiencyPsychosisSchizophreniaSchizoaffective Disorder

Keywords

Psychiatric illnessesVitamin D deficiencyObesity

Outcome Measures

Primary Outcomes (1)

  • Change in Weight

    Baseline and 8 weeks

Secondary Outcomes (8)

  • Insulin Resistance as Measured by HOMA-IR at Baseline and Post-treatment

    Baseline and 8 weeks

  • Changes in Serum Levels of C-reactive Protein.

    Baseline and 8 weeks

  • HDL-cholesterol at Baseline and Post-treatment

    Baseline and 8 weeks

  • LDL-cholesterol at Baseline and Post-treatment

    Baseline and 8 weeks

  • Total Cholesterol at Baseline and Post-treatment

    Baseline and 8 weeks

  • +3 more secondary outcomes

Study Arms (1)

Vitamin D

EXPERIMENTAL
Drug: Ergocalciferols

Interventions

ErgocalciferolsDRUG

2000 international units by mouth daily for 8 weeks.

Also known as: Drisdol
Vitamin D

Eligibility Criteria

Age10 Years - 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Males/females between the ages 10 through 18 years,
  • Subjects with Diagnostic and Statistical Manual of Mental Disorders-Fourth Edition (DSM-IV)\[62\] Axis 1 diagnosis who are on treatment with SGA. These conditions include schizophrenia, schizo-affective disorder, and psychosis,
  • Subjects who have gained 10% of their pre-drug body weight while receiving the following SGAs: risperidone, aripiprazole, clozapine, quetiapine and olanzapine. Subjects could be taking other psychotropic agents, but only one SGA,
  • All subjects will be able to take the prescribed vitamin D by mouth,
  • All subjects will have a 25-hydroxyvitamin D level of \< 32 ng/mL,
  • All subjects must reside in an in-patient psychiatric facility.

You may not qualify if:

  • Pregnant or lactating women,
  • Patients with mental retardation (intelligence quotient \< 50),
  • Subjects with specific systemic diseases such as diabetes mellitus, liver and kidney diseases,
  • Subjects with known history of parathyroid disorder,
  • Subjects with acquired or congenital disorders of vitamin D metabolism,
  • Subjects on calcium and vitamin D replacement therapy, such as calcium carbonate, or ergocalciferol, or cholecalciferol,
  • Subjects taking any weight loss medications, such as orlistat, and sibutramine,
  • Subjects on medications that might affect glucose levels, such as insulin or metformin.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Massachusetts Medical School

Worcester, Massachusetts, 01655, United States

Location

MeSH Terms

Conditions

ObesityVitamin D DeficiencyPsychotic DisordersSchizophreniaMental Disorders

Interventions

Ergocalciferols

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsAvitaminosisDeficiency DiseasesMalnutritionSchizophrenia Spectrum and Other Psychotic Disorders

Intervention Hierarchy (Ancestors)

CholestenesCholestanesSteroidsFused-Ring CompoundsPolycyclic CompoundsSterolsVitamin DSecosteroidsMembrane LipidsLipids

Results Point of Contact

Title
Benjamin U Nwosu, MD
Organization
University of Massachusetts Medical School
benjamin.nwosu@umassmemorial.org
5083347872

Study Officials

  • Benjamin U Nwosu, MD

    University of Massachusetts, Worcester

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Study Principal Investigator

Study Record Dates

First Submitted

October 28, 2009

First Posted

October 29, 2009

Study Start

June 1, 2009

Primary Completion

June 1, 2010

Study Completion

June 1, 2010

Last Updated

November 6, 2017

Results First Posted

February 10, 2012

Record last verified: 2017-11

Locations

US(1)