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Vitamin D Supplementation in Psychiatric Illnesses (VDSS)

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ClinicalTrials.gov Identifier: NCT01004354
Recruitment Status : Completed
First Posted : October 29, 2009
Results First Posted : February 10, 2012
Last Update Posted : November 6, 2017
Sponsor:
Information provided by (Responsible Party):
Benjamin U. Nwosu, University of Massachusetts, Worcester

Tracking Information
First Submitted Date  ICMJE October 28, 2009
First Posted Date  ICMJE October 29, 2009
Results First Submitted Date  ICMJE October 17, 2011
Results First Posted Date  ICMJE February 10, 2012
Last Update Posted Date November 6, 2017
Study Start Date  ICMJE June 2009
Actual Primary Completion Date June 2010   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 10, 2012)
Change in Weight [ Time Frame: Baseline and 8 weeks ]
Original Primary Outcome Measures  ICMJE
 (submitted: October 28, 2009)
Changes in waist circumference. [ Time Frame: 8 weeks ]
Change History Complete list of historical versions of study NCT01004354 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: November 1, 2017)
  • 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 ]
Original Secondary Outcome Measures  ICMJE
 (submitted: October 28, 2009)
  • 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 ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Vitamin D Supplementation in Psychiatric Illnesses
Official Title  ICMJE Effect of Vitamin D Supplementation on the Metabolic Abnormalities of Second Generation Antipsychotics in Children and Adolescents
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.
Detailed Description In this 8-week open label trial, we will enroll 10 subjects who fulfill the Inclusion Criteria.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Obesity
  • Vitamin D Deficiency
  • Psychosis
  • Schizophrenia
  • Schizoaffective Disorder
Intervention  ICMJE Drug: Ergocalciferols
2000 international units by mouth daily for 8 weeks.
Other Name: Drisdol
Study Arms  ICMJE Experimental: Vitamin D
Intervention: Drug: Ergocalciferols
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: January 10, 2012)
12
Original Estimated Enrollment  ICMJE
 (submitted: October 28, 2009)
10
Actual Study Completion Date  ICMJE June 2010
Actual Primary Completion Date June 2010   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 10 Years to 18 Years   (Child, Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01004354
Other Study ID Numbers  ICMJE Docket #13212
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Benjamin U. Nwosu, University of Massachusetts, Worcester
Study Sponsor  ICMJE University of Massachusetts, Worcester
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Benjamin U Nwosu, MD University of Massachusetts, Worcester
PRS Account University of Massachusetts, Worcester
Verification Date November 2017

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