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Sponsors and Collaborators: |
National Heart, Lung, and Blood Institute (NHLBI) Children's Hospital & Research Center Oakland Children's Hospital of Philadelphia University of California, San Francisco |
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Information provided by: | National Heart, Lung, and Blood Institute (NHLBI) |
ClinicalTrials.gov Identifier: | NCT00480415 |
Many people with the blood disorder thalassemia also have osteoporosis, possibly caused by low zinc levels. This study will evaluate the effectiveness of zinc supplements at improving bone health in individuals with thalassemia.
Condition | Intervention | Phase |
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Thalassemia |
Dietary Supplement: Zinc Supplements |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator), Placebo Control, Parallel Assignment, Efficacy Study |
Official Title: | Zinc and Bone Metabolism in Thalassemia |
Estimated Enrollment: | 60 |
Study Start Date: | April 2006 |
Estimated Study Completion Date: | December 2009 |
Estimated Primary Completion Date: | September 2009 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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I: Experimental
n/a
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Dietary Supplement: Zinc Supplements
25 mg/day of zinc as zn sulfate
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Thalassemia is an inherited blood disorder that causes mild to severe anemia. In people with thalassemia, an abnormal or missing gene impairs the body's ability to make hemoglobin, a red blood cell protein that carries oxygen. Many individuals with this disease also have osteoporosis, which is likely caused by a combination of factors, including disease state, hormones, and nutrition. The nutrient zinc plays an important role in bone strength and is often deficient in people with thalassemia. The most effective way to prevent osteoporosis is to build strong, dense bones early in life. Correcting low zinc levels at an early age may prevent the onset of osteoporosis in people with thalassemia. The purpose of this study is to evaluate the effectiveness of zinc supplements in improving bone health in young individuals with thalassemia.
This 18-month study will enroll children and young adults with thalassemia and low bone mass. Participants will be randomly assigned to receive either 25 mg of zinc or placebo daily. Study visits will occur at baseline and Months 3, 6, 12, and 18. Each visit will include height, weight, and body fat measurements; blood and urine collection; and a health questionnaire. At baseline and Months 12 and 18, bone density will be measured with x-rays, and a food frequency questionnaire will be completed. At the baseline study visit, participants less than 21 years of age will have x-ray images taken of their hand to assess bone age, which is the degree of maturation of their bones. Study staff will monitor medication adherence through pill counts.
Ages Eligible for Study: | 6 Years to 30 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
United States, California | |
Children's Hospital & Research Center Oakland | |
Oakland, California, United States, 94609 | |
University of California, San Francisco | |
San Francisco, California, United States, 94143 | |
United States, Pennsylvania | |
Children's Hospital of Philadelphia | |
Philadelphia, Pennsylvania, United States, 19104 |
Principal Investigator: | Ellen B. Fung, PhD, RD | Children's Hospital & Research Center Oakland |
Study Director: | Elliott Vichinsky, MD | Children's Hospital & Research Center Oakland |
Responsible Party: | Children's Hospital & Research Center, Oakland ( Ellen Fung, PhD RD; Assistant Research Scientist ) |
Study ID Numbers: | 484, K23 HL076468 |
Study First Received: | May 29, 2007 |
Last Updated: | February 18, 2009 |
ClinicalTrials.gov Identifier: | NCT00480415 History of Changes |
Health Authority: | United States: Federal Government |
Zinc Bone Mineral Density |
Anemia, Hemolytic, Congenital Genetic Diseases, Inborn Hematologic Diseases Hemoglobinopathies Zinc Anemia |
Anemia, Hemolytic Trace Elements Micronutrients Hemoglobinopathy Thalassemia |
Hematologic Diseases Growth Substances Physiological Effects of Drugs Anemia Anemia, Hemolytic Trace Elements Thalassemia |
Pharmacologic Actions Anemia, Hemolytic, Congenital Genetic Diseases, Inborn Hemoglobinopathies Zinc Micronutrients |