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Sponsors and Collaborators: |
University of Iowa National Institutes of Health (NIH) Children's Miracle Network |
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Information provided by: | University of Iowa |
ClinicalTrials.gov Identifier: | NCT00799383 |
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 |
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Hyperprolactinemia |
Dietary Supplement: Calcium and Vitamin D |
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 |
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 |
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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.
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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.
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Ages Eligible for Study: | 5 Years to 17 Years |
Genders Eligible for Study: | Male |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Amy Librant | 319-335-7349 | amy-librant@uiowa.edu |
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 |
Principal Investigator: | Chadi Calarge, M.D. | The University of Iowa |
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 |
Risperidone hyperprolactinemia children adolescents antipsychotics |
prevention calcium vitamin D Risperidone-induced hyperprolactinemia |
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 |
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 |