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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: November 6, 2017
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
October 28, 2009
October 29, 2009
October 17, 2011
February 10, 2012
November 6, 2017
June 2009
June 2010   (Final data collection date for primary outcome measure)
Change in Weight [ Time Frame: Baseline and 8 weeks ]
Changes in waist circumference. [ Time Frame: 8 weeks ]
Complete list of historical versions of study NCT01004354 on ClinicalTrials.gov Archive Site
  • Insulin Resistance as Measured by HOMA-IR at Baseline and Post-treatment [ Time Frame: Baseline and 8 weeks ]

    HOMA-IR:

    It is calculated multiplying fasting plasma insulin (FPI) by fasting plasma glucose (FPG), then dividing by the constant 22.5, i.e. HOMA-IR = (FPI×FPG)/22.5

  • Changes in Serum Levels of C-reactive Protein. [ Time Frame: Baseline and 8 weeks ]
  • HDL-cholesterol at Baseline and Post-treatment [ Time Frame: Baseline and 8 weeks ]
  • LDL-cholesterol at Baseline and Post-treatment [ Time Frame: Baseline and 8 weeks ]
  • Total Cholesterol at Baseline and Post-treatment [ Time Frame: Baseline and 8 weeks ]
  • Triglycerides at Baseline and Post-treatment [ Time Frame: Baseline and 8 weeks ]
  • Adiponectin at Baseline and Post-treatment [ Time Frame: Baseline and 8 weeks ]
  • Leptin at Baseline and Post-treatment [ Time Frame: Baseline and 8 weeks ]
  • 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 ]
Not Provided
Not Provided
 
Vitamin D Supplementation in Psychiatric Illnesses
Effect of Vitamin D Supplementation on the Metabolic Abnormalities of Second Generation Antipsychotics in Children and Adolescents
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.
In this 8-week open label trial, we will enroll 10 subjects who fulfill the Inclusion Criteria.
Interventional
Not Provided
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
  • Obesity
  • Vitamin D Deficiency
  • Psychosis
  • Schizophrenia
  • Schizoaffective Disorder
Drug: Ergocalciferols
2000 international units by mouth daily for 8 weeks.
Other Name: Drisdol
Experimental: Vitamin D
Intervention: Drug: Ergocalciferols
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
12
June 2010
June 2010   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: All
10 Years to 18 Years   (Child, Adult)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT01004354
Docket #13212
No
Not Provided
Not Provided
Benjamin U. Nwosu, University of Massachusetts, Worcester
University of Massachusetts, Worcester
Not Provided
Principal Investigator: Benjamin U Nwosu, MD University of Massachusetts, Worcester
University of Massachusetts, Worcester
November 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP