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Calcium and Vitamin D to Optimize Bone Mass in Boys With Risperidone-Induced Hyperprolactinemia
This study is currently recruiting participants.
Verified by University of Iowa, November 2008
Sponsors and Collaborators: University of Iowa
National Institutes of Health (NIH)
Children's Miracle Network
Information provided by: University of Iowa
ClinicalTrials.gov Identifier: NCT00799383
  Purpose

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.


Condition Intervention
Hyperprolactinemia
Dietary Supplement: Calcium and Vitamin D

MedlinePlus related topics: Calcium Minerals
Drug Information available for: Risperidone Calcium gluconate Vitamin D Ergocalciferol Calcium carbonate
U.S. FDA Resources
Study Type: Interventional
Study Design: Prevention, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Efficacy Study
Official Title: Counteracting Risperidone-Induced Hyperprolactinemia in Youths

Further study details as provided by University of Iowa:

Primary Outcome Measures:
  • Trabecular bone mineral density in the ultradistal radius [ Time Frame: 9 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • total body bone mineral content [ Time Frame: 9 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 50
Study Start Date: November 2008
Estimated Primary Completion Date: June 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Calcium+VitD: Experimental Dietary Supplement: Calcium and Vitamin D
Calcium carbonate 625mg and vitamin D 200IU will be administered, orally, twice a day for a nine-month period.
Placebo: Placebo Comparator Dietary Supplement: Calcium and Vitamin D
Calcium carbonate 625mg and vitamin D 200IU will be administered, orally, twice a day for a nine-month period.

  Eligibility

Ages Eligible for Study:   5 Years to 17 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  1. 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.
  2. Participants receiving calcium or multivitamins in the previous three months.
  3. 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).
  4. Laboratory values outside the normal range, except for prolactin, unless the deviations were not clinically significant (e.g. TSH < 10 μIU/ml (76)).
  5. Inability to cooperate with the BMD measurements.
  6. Bilateral wrist or forearm fractures.
  7. Eating disorders.
  8. Non-compliance with the prescribed psychiatric treatment as reflected by an undetectable combined risperidone and 9-hydroxy risperidone blood concentration.
  9. Plans to move out of State within the next 9 months.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00799383

Contacts
Contact: Amy Librant 319-335-7349 amy-librant@uiowa.edu

Locations
United States, Iowa
The University of Iowa Recruiting
Iowa City, Iowa, United States, 52242
Contact: Jennifer Lassner     319-335-2123     jennifer-lassner@uiowa.edu    
Principal Investigator: Chadi A Calarge, MD            
Sponsors and Collaborators
University of Iowa
Children's Miracle Network
Investigators
Principal Investigator: Chadi Calarge, M.D. The University of Iowa
  More Information

Responsible Party: The University of Iowa ( Chadi Calarge )
Study ID Numbers: K23-MH085005
Study First Received: November 25, 2008
Last Updated: November 26, 2008
ClinicalTrials.gov Identifier: NCT00799383  
Health Authority: United States: Food and Drug Administration

Keywords provided by University of Iowa:
Risperidone
hyperprolactinemia
children
adolescents
antipsychotics
prevention
calcium
vitamin D
Risperidone-induced hyperprolactinemia

Study placed in the following topic categories:
Hypothalamic Diseases
Pituitary Diseases
Ergocalciferols
Risperidone
Central Nervous System Diseases
Endocrine System Diseases
Calcium Carbonate
Brain Diseases
Serotonin
Calcium, Dietary
Dopamine
Vitamin D
Galactorrhoea-Hyperprolactinaemia
Hyperprolactinemia
Endocrinopathy

Additional relevant MeSH terms:
Neurotransmitter Agents
Tranquilizing Agents
Molecular Mechanisms of Pharmacological Action
Growth Substances
Nervous System Diseases
Physiological Effects of Drugs
Psychotropic Drugs
Central Nervous System Depressants
Dopamine Antagonists
Bone Density Conservation Agents
Antipsychotic Agents
Pharmacologic Actions
Serotonin Antagonists
Hyperpituitarism
Serotonin Agents
Therapeutic Uses
Vitamins
Dopamine Agents
Micronutrients
Central Nervous System Agents

ClinicalTrials.gov processed this record on January 16, 2009