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OpenTrials
Completed

NCT Number: NCT01004354

Vitamin D Supplementation in Psychiatric Illnesses

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.

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Key information

Age range

10 year–18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Massachusetts Medical School

Worcester, Massachusetts, 01655, United States

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Males/females between the ages 10 through 18 years,
  • 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,
  • 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.

Exclusion criteria

  • 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.

Treatment and study plan

Ergocalciferols

Drug

2000 international units by mouth daily for 8 weeks.

Other names: Drisdol

Primary outcomes

  1. Change in Weight

    Time frame: Baseline and 8 weeks

Secondary outcomes

  1. 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

  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

Sponsors and collaborators

Lead sponsor

University of Massachusetts, Worcester

Other

Registry information

Official study title

Effect of Vitamin D Supplementation on the Metabolic Abnormalities of Second Generation Antipsychotics in Children and Adolescents

Acronym: VDSS

Important dates

Study start
2009
Primary completion
2010
Study completion
2010
First posted
Oct 29, 2009
Registry last updated
Nov 6, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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