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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 History of Changes |
Health Authority: | United States: Food and Drug Administration |
Risperidone hyperprolactinemia children adolescents antipsychotics |
prevention calcium vitamin D Risperidone-induced hyperprolactinemia |
Neurotransmitter Agents Psychotropic Drugs Bone Density Conservation Agents Calcium Carbonate Brain Diseases Dopamine Vitamins Hyperprolactinemia Micronutrients Hypothalamic Diseases Tranquilizing Agents Pituitary Diseases Ergocalciferol Risperidone |
Ergocalciferols Endocrine System Diseases Central Nervous System Diseases Central Nervous System Depressants Trace Elements Antipsychotic Agents Serotonin Calcium, Dietary Vitamin D Vitamin D2 Galactorrhoea-Hyperprolactinaemia Dopamine Agents Calciferol Endocrinopathy |
Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Physiological Effects of Drugs Psychotropic Drugs Bone Density Conservation Agents Brain Diseases Serotonin Antagonists Hyperpituitarism Therapeutic Uses Vitamins Hyperprolactinemia Micronutrients Hypothalamic Diseases Tranquilizing Agents Pituitary Diseases |
Growth Substances Nervous System Diseases Risperidone Ergocalciferols Endocrine System Diseases Central Nervous System Diseases Central Nervous System Depressants Dopamine Antagonists Antipsychotic Agents Pharmacologic Actions Vitamin D Serotonin Agents Dopamine Agents Central Nervous System Agents |