University of Massachusetts Medical School
Worcester, Massachusetts, 01655, United States
NCT Number: NCT01004354
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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Notify Me10 year–18 year
All sexes
Interventional
Not applicable
Worcester, Massachusetts, 01655, United States
In this 8-week open label trial, we will enroll 10 subjects who fulfill the Inclusion Criteria.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
2000 international units by mouth daily for 8 weeks.
Other names: Drisdol
Time frame: Baseline and 8 weeks
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
Time frame: Baseline and 8 weeks
Time frame: Baseline and 8 weeks
Time frame: Baseline and 8 weeks
Time frame: Baseline and 8 weeks
Time frame: Baseline and 8 weeks
Time frame: Baseline and 8 weeks
Time frame: Baseline and 8 weeks
University of Massachusetts, Worcester
Other
Effect of Vitamin D Supplementation on the Metabolic Abnormalities of Second Generation Antipsychotics in Children and Adolescents
Acronym: VDSS
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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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