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Vitamin D Supplementation in Psychiatric Illnesses (VDSS)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01004354
First Posted: October 29, 2009
Last Update Posted: February 10, 2012
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Benjamin U. Nwosu, University of Massachusetts, Worcester
  Purpose
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.

Condition Intervention
Obesity Vitamin D Deficiency Psychosis Schizophrenia Schizoaffective Disorder Drug: Ergocalciferols

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Effect of Vitamin D Supplementation on the Metabolic Abnormalities of Second Generation Antipsychotics in Children and Adolescents

Resource links provided by NLM:


Further study details as provided by Benjamin U. Nwosu, University of Massachusetts, Worcester:

Primary Outcome Measures:
  • Change in Weight [ Time Frame: Baseline and 8 weeks ]

Secondary Outcome Measures:
  • Changes in the Baseline and Post-treatment Values of the Markers of the Metabolic Syndrome (Insulin, C-peptide, Fasting Blood Glucose, Homeostasis Model of Insulin Resistance (HOMA-IR), High Density Lipoprotein Cholesterol). [ Time Frame: 8 weeks ]
  • Changes in Serum Levels of Adiponectin, Leptin, and C-reactive Protein. [ Time Frame: 8 weeks ]

Enrollment: 12
Study Start Date: June 2009
Study Completion Date: June 2010
Primary Completion Date: June 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Vitamin D Drug: Ergocalciferols
2000 international units by mouth daily for 8 weeks.
Other Name: Drisdol

Detailed Description:
In this 8-week open label trial, we will enroll 10 subjects who fulfill the Inclusion Criteria.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   10 Years to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Males/females between the ages 10 through 18 years,
  2. 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,
  3. 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,
  4. All subjects will be able to take the prescribed vitamin D by mouth,
  5. All subjects will have a 25-hydroxyvitamin D level of < 32 ng/mL,
  6. All subjects must reside in an in-patient psychiatric facility.

Exclusion Criteria:

  1. Pregnant or lactating women,
  2. Patients with mental retardation (intelligence quotient < 50),
  3. Subjects with specific systemic diseases such as diabetes mellitus, liver and kidney diseases,
  4. Subjects with known history of parathyroid disorder,
  5. Subjects with acquired or congenital disorders of vitamin D metabolism,
  6. Subjects on calcium and vitamin D replacement therapy, such as calcium carbonate, or ergocalciferol, or cholecalciferol,
  7. Subjects taking any weight loss medications, such as orlistat, and sibutramine,
  8. Subjects on medications that might affect glucose levels, such as insulin or metformin.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01004354


Locations
United States, Massachusetts
University of Massachusetts Medical School
Worcester, Massachusetts, United States, 01655
Sponsors and Collaborators
University of Massachusetts, Worcester
Investigators
Principal Investigator: Benjamin U Nwosu, MD University of Massachusetts, Worcester
  More Information

Responsible Party: Benjamin U. Nwosu, Study Principal Investigator, University of Massachusetts, Worcester
ClinicalTrials.gov Identifier: NCT01004354     History of Changes
Other Study ID Numbers: Docket #13212
First Submitted: October 28, 2009
First Posted: October 29, 2009
Results First Submitted: October 17, 2011
Results First Posted: February 10, 2012
Last Update Posted: February 10, 2012
Last Verified: January 2012

Keywords provided by Benjamin U. Nwosu, University of Massachusetts, Worcester:
Psychiatric illnesses
Vitamin D deficiency
Obesity

Additional relevant MeSH terms:
Schizophrenia
Psychotic Disorders
Vitamin D Deficiency
Mental Disorders
Schizophrenia Spectrum and Other Psychotic Disorders
Avitaminosis
Deficiency Diseases
Malnutrition
Nutrition Disorders
Vitamins
Vitamin D
Ergocalciferols
Micronutrients
Growth Substances
Physiological Effects of Drugs
Bone Density Conservation Agents