N/A
N=40
Zinc & Bone Health in Thalassemia: The Think Zinc Study
Thalassemia
Bottom Line
View on ClinicalTrials.gov: NCT00459732 ↗Enrolled (actual)
40
Serious AEs
2.5%
Results posted
Sep 2011
Primary outcome: Primary: Change in Lumbar Spine Bone Mineral Density (BMD) by DXA (Baseline to 18 Months) — 5.9; 1.5 Percent Change — p=0.13
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Zinc (Dietary_supplement); Placebo (Dietary_supplement)
- Age
- Pediatric, Adult · 6+ yrs
- Sex
- All
- Sponsor
- UCSF Benioff Children's Hospital Oakland
- Primary completion
- Oct 2009
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Lumbar Spine Bone Mineral Density (BMD) by DXA (Baseline to 18 Months) |
5.9; 1.5 | 0.13 |
| PRIMARY Change in Whole Body Bone Mineral Content (BMC) by DXA (Baseline to 18 Months) |
6.1; 2.2 | 0.44 |
| SECONDARY Osteocalcin, a Marker of Bone Formation |
8.8; -4.3 | 0.16 |
Summary
The purpose of this study is to test whether zinc can improve bone health in young patients with thalassemia.
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT00459732). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.