The purpose of this study is to determine if zinc supplementation improves bone health in young patients with thalassemia. Osteoporosis (weak bones) is a significant problem in patients with thalassemia which leads to decreased quality of life. The most effective way to prevent osteoporosis is to build strong, dense bones during youth. A combination of disease, endocrine issues, and nutritional factors likely contribute to the etiology of osteoporosis in patients with thalassemia. However, even patients who are well transfused, have normal reproductive function, and are supplemented with calcium are at risk for osteoporosis.
It is theorized that patients with thalassemia have weak bones, in part, due to zinc deficiency. Poor zinc status has been identified in patients with thalassemia, and zinc supplementation has been shown to improve growth. To test this theory, an 18-month study will be conducted in 60 patients (age 6 to 30) with thalassemia who have low bone mass. The study will be placebo-controlled, meaning that one group of patients will be given zinc supplementation (25 mg zinc per day), while the other patients will undergo their usual therapy without zinc supplementation.
This will be the first study to examine the effects of zinc supplementation on bone health in patients with thalassemia. If zinc supplementation is found to have a clinically important effect, this simple, safe, non-invasive therapy could quickly become a part of standard thalassemia care and will improve overall health in children and adult patients with thalassemia.
Who can participate?
- Patients with thalassemia (including transfusion dependent beta-thalassemia, non-transfusion dependent beta-thalassemia, and E/beta-thalassemia)
- Patients 6 to 30 years of age
- Patients with low bone mass (defined as a bone mineral density Z-score by DXA < -1.0 performed within the previous two years)
- Patients who are pregnant
- Patients currently taking a bisphosphonate medication for osteoporosis
- Patients who have had a bone marrow transplant
Length of Study: 1½ years (18 months)
Sites of Recruitment: Children’s Hospital & Research Center, Oakland;
What does the study involve?
University of California San Francisco, Stanford, Children’s Hospital of Central California, Children’s Hospital of Philadelphia
- Patients will be asked to consume a zinc supplement or placebo capsule daily for 1½ years.
- Five times during the study (beginning, 3 months, 6 months, 1 year, and 1.5 years), patients will be asked to come to the pediatric clinical research center to do the following:
- measure height, weight and other body segments
- complete a questionnaire on dietary habits
- have blood drawn and provide a urine sample
- pick up new pills and return used bottles
- Three times during the study (beginning, 1 year and 1½ years), patients will be asked to come to the HEDCO Health Science building to undergo bone density testing.
Benefits of participating in the study:
- Complete dietary assessment and information on bone health at the beginning of the study
- Free bone density assessments
- Reimbursement for parking, meals, time, and effort related to study participation
For more information, please contact Ellen Fung, PhD, RD at Children's Hospital & Research Center at Oakland, 510-428-3885, ext. 4939 or ask your clinical care provider.
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