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

Completed · Phase 3 · Has a placebo group

Conditions studied: Risperidone-induced Hyperprolactinemia

In brief

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.

Key facts

Study ID

NCT00799383

Run by

Chadi A. Calarge

People needed

47

Starts

2008-11-01

Expected to finish

2014-03-01

Last updated by the study team

2017-12-26

Who can join

Age: 5 and older, up to 17. Sex: male. Healthy volunteers: not accepted.

You may qualify if…

• Males (age range: 5-17yo; inclusive), in treatment with risperidone for ≥ one year.
• The participants must have two measurements of prolactin ≥ 18.4 ng/ml, obtained within a week.
• IQ > 35-40 (≥ Moderate intellectual disability).
• An adult parent/guardian must be available to provide consent and dispense study medication.

You may not qualify if…

• Chronic disorders involving a vital organ (heart, lung, liver, kidney, brain), metabolic diseases (e.g., diabetes, hypo- or hyperparathyroidism, hypo- or hyperthyroidism, growth hormone deficiency), other skeletal diseases (e.g., Paget's disease, osteogenesis imperfecta, rheumatoid arthritis), chronic use of drugs affecting bone metabolism (e.g., corticosteroids), and malnutrition conditions (e.g., chronic diarrhea, inflammatory bowel disease), congenital disorders, or lead poisoning.
• Participants receiving calcium or multivitamins in the previous three months.
• A history of renal calculi and fasting random urine calcium/creatinine ratio > 0.2 or any other medical disorder that contraindicates the use of calcium or vitamin D (e.g., hypercalcemic states, hypercoagulability disorders, vitamin D toxicity, malabsorption syndrome, or hypersensitivity to vitamin D products).
• Laboratory values outside the normal range, except for prolactin, unless the deviations were not clinically significant (e.g. TSH < 10 μIU/ml (76)).
• Inability to cooperate with the BMD measurements.
• Bilateral wrist or forearm fractures.
• Eating disorders.
• Non-compliance with the prescribed psychiatric treatment as reflected by an undetectable combined risperidone and 9-hydroxy risperidone blood concentration.
• Plans to move out of State within the next 9 months.

Where it is running

• The University of Iowa — Iowa City, Iowa, United States

Full record on ClinicalTrials.gov

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