Vitamin D Supplementation in Psychiatric Illnesses (VDSS)
This study has been completed.
Information provided by (Responsible Party):
Benjamin U. Nwosu, University of Massachusetts, Worcester
First received: October 28, 2009
Last updated: January 10, 2012
Last verified: January 2012
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.
Vitamin D Deficiency
||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
||Effect of Vitamin D Supplementation on the Metabolic Abnormalities of Second Generation Antipsychotics in Children and Adolescents
Primary Outcome Measures:
- Change in Weight [ Time Frame: Baseline and 8 weeks ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: No ]
- Changes in Serum Levels of Adiponectin, Leptin, and C-reactive Protein. [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
| Study Start Date:
| Study Completion Date:
| Primary Completion Date:
||June 2010 (Final data collection date for primary outcome measure)
Experimental: Vitamin D
2000 international units by mouth daily for 8 weeks.
Other Name: Drisdol
In this 8-week open label trial, we will enroll 10 subjects who fulfill the Inclusion Criteria.
|Ages Eligible for Study:
||10 Years to 18 Years
|Genders Eligible for Study:
|Accepts Healthy Volunteers:
- Males/females between the ages 10 through 18 years,
- Subjects with Diagnostic and Statistical Manual of Mental Disorders-Fourth Edition (DSM-IV) 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.
- 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.
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01004354
|University of Massachusetts Medical School
|Worcester, Massachusetts, United States, 01655 |
University of Massachusetts, Worcester
||Benjamin U Nwosu, MD
||University of Massachusetts, Worcester
No publications provided
||Benjamin U. Nwosu, Study Principal Investigator, University of Massachusetts, Worcester
History of Changes
|Other Study ID Numbers:
|Study First Received:
||October 28, 2009
|Results First Received:
||October 17, 2011
||January 10, 2012
||United States: Institutional Review Board
Keywords provided by University of Massachusetts, Worcester:
Vitamin D deficiency
Additional relevant MeSH terms:
ClinicalTrials.gov processed this record on October 07, 2015
Vitamin D Deficiency
Schizophrenia and Disorders with Psychotic Features
Bone Density Conservation Agents
Physiological Effects of Drugs