Zinc & Bone Health in Thalassemia: The Think Zinc Study (ThinkZn)

UCSF Benioff Children's Hospital Oakland

Status

Completed

Conditions

Thalassemia

Treatments

Dietary Supplement: Zinc

Dietary Supplement: Placebo

Study type

Interventional

Funder types

Other

NIH

Identifiers

NCT00459732

2004-106

K23HL076468 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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

Full 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

Enrollment

45 patients

Sex

All

Ages

6 to 30 years old

Volunteers

No Healthy Volunteers

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