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Calcium and Vitamin D to Optimize Bone Mass in Boys With Risperidone-induced Hyperprolactinemia

NCT00799383 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 47

Last updated 2017-12-26

Study results available
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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.

Conditions

  • Risperidone-induced Hyperprolactinemia

Interventions

DRUG

Calcium and Vitamin D

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

OTHER

Placebo

Sponsors & Collaborators

  • National Institute of Mental Health (NIMH)

    collaborator NIH

  • Children's Miracle Network

    collaborator OTHER

  • Chadi A. Calarge

    lead OTHER

Principal Investigators

  • Chadi Calarge, M.D. · University of Iowa

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
5 Years
Max Age
17 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-11-30
Primary Completion
2014-03-31
Completion
2014-03-31
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00799383 on ClinicalTrials.gov