Conditions: Risperidone-induced Hyperprolactinemia
Keywords: Risperidone hyperprolactinemia children adolescents antipsychotics prevention calcium vitamin D Risperidone-induced hyperprolactinemia
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 47
Healthy volunteers: no

Brief 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.

Detailed description:

Arms:
arm 1: Calcium carbonate 625mg and vitamin D 200IU will be administered, orally, twice a day for a nine-month period. arm 2: Placebo

Interventions: intervention 1: Calcium and Vitamin D intervention 2: Placebo
Intervention descriptions: intervention 1: Calcium carbonate 625mg and vitamin D 200IU will be administered, orally, twice a day for a nine-month period. intervention 2: None

Protocol document: