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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
Information provided by (Responsible Party):
Benjamin U. Nwosu, University of Massachusetts, Worcester

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.

Condition or disease Intervention/treatment
Obesity Vitamin D Deficiency Psychosis Schizophrenia Schizoaffective Disorder Drug: Ergocalciferols

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

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 12 participants
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
Study Start Date : June 2009
Primary Completion Date : June 2010
Study Completion Date : June 2010

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Experimental: Vitamin D Drug: Ergocalciferols
2000 international units by mouth daily for 8 weeks.
Other Name: Drisdol

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

Secondary Outcome Measures :
  1. Insulin Resistance as Measured by HOMA-IR at Baseline and Post-treatment [ Time Frame: Baseline and 8 weeks ]


    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

  2. Changes in Serum Levels of C-reactive Protein. [ Time Frame: Baseline and 8 weeks ]
  3. HDL-cholesterol at Baseline and Post-treatment [ Time Frame: Baseline and 8 weeks ]
  4. LDL-cholesterol at Baseline and Post-treatment [ Time Frame: Baseline and 8 weeks ]
  5. Total Cholesterol at Baseline and Post-treatment [ Time Frame: Baseline and 8 weeks ]
  6. Triglycerides at Baseline and Post-treatment [ Time Frame: Baseline and 8 weeks ]
  7. Adiponectin at Baseline and Post-treatment [ Time Frame: Baseline and 8 weeks ]
  8. Leptin at Baseline and Post-treatment [ Time Frame: Baseline and 8 weeks ]

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

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.

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

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

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 Posted: October 29, 2009    Key Record Dates
Results First Posted: February 10, 2012
Last Update Posted: November 6, 2017
Last Verified: November 2017

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

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