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

Phase 3 Completed 47 enrolled Chadi A. Calarge Children's Miracle Network · collab National Institute of Mental Health (NIMH) · collab

RandomizedParallel-groupQuadruple-blindPrevention

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.

Timeline

Start: 2008-11
Primary completion: 2014-03
Completion: 2014-03

Publications

Calarge CA, Mills JA, Ziegler EE, Schlechte JA. Calcium and Vitamin D Supplementation in Boys with Risperidone-Induced Hyperprolactinemia: A Randomized, Placebo-Controlled Pilot Study. J Child Adolesc Psychopharmacol. 2018 Mar;28(2):145-150. doi: 10.1089/cap.2017.0104. Epub 2017 Nov 7.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Calcium carbonate	Other / unclassified	625 mg	Oral
Subject	Cholecalciferol	Other / unclassified	200 iu	Oral

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

Summary

Timeline

Publications

Drugs

Indications