CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 47 enrolled
Drug / intervention
Calcium and Vitamin D +1 moredrug
Likely dose
Calcium and Vitamin D 625mgfrom 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/NCT00799383
NCT00799383Phase 3Completed
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Counteracting Risperidone-Induced Hyperprolactinemia in Youths

Chadi A. Calarge·interventional·Posted Nov 27, 2008·Updated Dec 26, 2017

In Brief

A Phase 3 clinical trial evaluating Calcium and Vitamin D and Placebo for Risperidone-induced Hyperprolactinemia. Completed, enrolled 47 participants across 1 site.

Detailed Summary

The purpose of this study is to determine whether calcium and vitamin D supplementation, over a nine-month period, optimizes bone mineralization in boys with risperidone-induced hyperprolactinemia. We hypothesize that, by the end of the stuy, children in the supplementation group will have higher bone mineral density compared to those in the placebo group.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsRisperidone-induced Hyperprolactinemia
CountriesUnited States
CollaboratorsNational Institute of Mental Health (NIMH), Children's Miracle Network

Timeline

Phase 3CompletedFinished
200920102011201220132014201520162017201820192020202120222023202420252026
First PostedNov 27, 2008
Enrollment StartNov 1, 2008
Primary CompletionMar 1, 2014
TodayJul 2, 2026
Enrollment to primary: 5.3 yearsPosted 17.6 years ago

Interventions

Calcium and Vitamin Ddrug

Calcium carbonate 625mg and vitamin D 200IU will be administered, orally, twice a day for a nine-month period.

Placeboother