N/A Completed N=40 Randomized Double-blind Treatment

Zinc & Bone Health in Thalassemia: The Think Zinc Study

Source: ClinicalTrials.gov NCT00459732 ↗

Enrolled (actual)

Serious AEs

2.5%

Results posted

Sep 2011

Primary outcomePrimary: Change in Lumbar Spine Bone Mineral Density (BMD) by DXA (Baseline to 18 Months) — 5.9; 1.5 Percent Change — p=0.13

Summary

The purpose of this study is to test whether zinc can improve bone health in young patients with thalassemia.

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

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

View full record on ClinicalTrials.gov →

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. Informational only — not medical advice.