Status:
COMPLETED
Zinc & Bone Health in Thalassemia: The Think Zinc Study
Lead Sponsor:
UCSF Benioff Children's Hospital Oakland
Collaborating Sponsors:
National Heart, Lung, and Blood Institute (NHLBI)
Children's Hospital of Philadelphia
Conditions:
Thalassemia
Eligibility:
All Genders
6-30 years
Phase:
NA
Brief Summary
The purpose of this study is to test whether zinc can improve bone health in young patients with thalassemia.
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 w...
Eligibility Criteria
Inclusion
- 6 to 30 years of age
- thalassemia
- bone mineral density Z-score \< -1.0 (by DXA)
Exclusion
- 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
Key Trial Info
Start Date :
April 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2011
Estimated Enrollment :
45 Patients enrolled
Trial Details
Trial ID
NCT00459732
Start Date
April 1 2006
End Date
February 1 2011
Last Update
December 4 2020
Active Locations (3)
Enter a location and click search to find clinical trials sorted by distance.
1
Children's Hospital & Research Center, Oakland
Oakland, California, United States, 94609
2
University of California, San Francisco
San Francisco, California, United States, 94143
3
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, United States, 19104