CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 12 enrolled
Drug / intervention
Ergocalciferolsdrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01004354
NCT01004354N/ACompleted
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Effect of Vitamin D Supplementation on the Metabolic Abnormalities of Second Generation Antipsychotics in Children and Adolescents

University of Massachusetts, Worcester·interventional·Posted Oct 29, 2009·Updated Nov 6, 2017

In Brief

A clinical study evaluating Ergocalciferols for Obesity and 4 related conditions. Completed, enrolled 12 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsObesity, Vitamin D Deficiency, Psychosis, Schizophrenia, Schizoaffective Disorder
CountriesUnited States
Collaborators--

Timeline

N/ACompletedFinished
200920102011201220132014201520162017201820192020202120222023202420252026
First PostedOct 29, 2009
Enrollment StartJun 1, 2009
Primary CompletionJun 1, 2010
TodayJul 2, 2026
Enrollment to primary: 1 yearPosted 16.7 years ago

Interventions

Ergocalciferolsdrug

2000 international units by mouth daily for 8 weeks.