Status:
COMPLETED
Calcium and Vitamin D to Optimize Bone Mass in Boys With Risperidone-induced Hyperprolactinemia
Lead Sponsor:
Chadi A. Calarge
Collaborating Sponsors:
National Institute of Mental Health (NIMH)
Children's Miracle Network
Conditions:
Risperidone-induced Hyperprolactinemia
Eligibility:
MALE
5-17 years
Phase:
PHASE3
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...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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.
Key Trial Info
Start Date :
November 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2014
Estimated Enrollment :
47 Patients enrolled
Trial Details
Trial ID
NCT00799383
Start Date
November 1 2008
End Date
March 1 2014
Last Update
December 26 2017
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
The University of Iowa
Iowa City, Iowa, United States, 52242