Zinc & Bone Health in Thalassemia: The Think Zinc Study (ThinkZn)
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Purpose
The purpose of this study is to test whether zinc can improve bone health in young patients with thalassemia.
| Condition | Intervention | Phase |
|---|---|---|
|
Thalassemia |
Dietary Supplement: Zinc Dietary Supplement: Placebo |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Treatment |
| Official Title: | Zinc and Bone Metabolism in Thalassemia |
- Change in Lumbar Spine Bone Mineral Density (BMD) by DXA (Baseline to 18 Months) [ Time Frame: 0 to 18 months ] [ Designated as safety issue: No ]Change in pa spine bone mineral density by DXA between baseline and 18 months
- Change in Whole Body Bone Mineral Content (BMC) by DXA (Baseline to 18 Months) [ Time Frame: Baseline to 18 months ] [ Designated as safety issue: No ]
- Osteocalcin, a Marker of Bone Formation [ Time Frame: Baseline to 18 months ] [ Designated as safety issue: No ]Absolute change in serum osteocalcin between 0 and 18 months, intention to treat analysis between the zinc and placebo groups
| Enrollment: | 45 |
| Study Start Date: | April 2006 |
| Study Completion Date: | February 2011 |
| Primary Completion Date: | October 2009 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Placebo Comparator: Placebo Capsule
placebo capsule, similar in size, shape and color to zinc capsule, taken once daily for 18 months
|
Dietary Supplement: Placebo
Placebo capsule, identical to the zn capsule in size, shape and color, taken once daily for 18 months
Other Name: "sugar" pill
|
|
Active Comparator: Zinc (25 mg/d)
25 mg of elemental Zinc as zinc sulphate taken once daily for 18 months
|
Dietary Supplement: Zinc
25 mg of elemental zinc as zinc sulphate take once daily for 18 months
Other Names:
|
Detailed Description:
The primary aim of this study is to determine if zinc supplementation improves bone health in young patients with thalassemia. Osteoporosis is a significant co-morbidity in patients with thalassemia which leads to decreased quality of life. The most effective way to prevent osteoporosis is to build strong, dense bones in the early years. A combination of disease, endocrine and nutritional factors likely contribute to the etiology of osteoporosis in this population. However, even well transfused patients with normal gonadal function who are supplemented with calcium have low bone mass. It is hypothesized that patients with thalassemia have low bone mass, in part, due to zinc deficiency. Sub-optimal zinc status has been identified in patients with thalassemia and zinc supplementation has been shown to improve linear growth. To test the primary hypothesis, an 18 month randomized placebo-controlled trial of zinc supplementation (25 mg Zn/day) vs. placebo will be conducted in 60 young patients (6-30 yrs) with thalassemia and low bone mass (spine BMD Z-score <-1.0). Bone health, as estimated from measurements of bone mass (by DXA and pQCT) and markers of bone formation and resorption will be the primary outcome variables. 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 the standard care of these young patients and improve overall health in children and adult patients with thalassemia
Eligibility| Ages Eligible for Study: | 6 Years to 30 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- 6 to 30 years of age
- thalassemia
- bone mineral density Z-score < -1.0 (by DXA)
Exclusion Criteria:
- Bone marrow transplant recipient
- Currently prescribed treatment for low bone mass other than calcium or vitamin D (e.g. calcitonin, bisphosphonates)
- Currently prescribed zinc supplementation who are unable or unwilling to stop during this trial
- Currently participating in another trial with a medication known to affect bone mineral density.
- Chronic use of systemic corticosteroids
- Untreated hypogonadism or growth hormone deficiency
- Baseline serum copper < 70 µg/dL
- Baseline vitamin D-25OH < 11 ng/mL
- Pregnant or lactating at study entry
Contacts and Locations| 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 |
More Information
No publications provided
| Responsible Party: | Children's Hospital & Research Center Oakland |
| ClinicalTrials.gov Identifier: | NCT00459732 History of Changes |
| Obsolete Identifiers: | NCT00480415 |
| Other Study ID Numbers: | 2004-106, K23HL076468 |
| Study First Received: | April 11, 2007 |
| Results First Received: | November 4, 2010 |
| Last Updated: | October 4, 2011 |
| Health Authority: | United States: Federal Government |
Keywords provided by Children's Hospital & Research Center Oakland:
|
zinc, thalassemia, bone mineral density |
Additional relevant MeSH terms:
|
Thalassemia Anemia, Hemolytic, Congenital Anemia, Hemolytic Anemia Hematologic Diseases Hemoglobinopathies Genetic Diseases, Inborn Zinc Zinc Sulfate |
Trace Elements Micronutrients Growth Substances Physiological Effects of Drugs Pharmacologic Actions Astringents Dermatologic Agents Therapeutic Uses |
ClinicalTrials.gov processed this record on May 16, 2013