NCT00459732

Zinc & Bone Health in Thalassemia: The Think Zinc Study

Zinc and Bone Metabolism in Thalassemia

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 45 (actual)
• Sponsor: UCSF Benioff Children's Hospital Oakland · Academic / Other
• Sex: All
• Age: 6 Years – 30 Years
• Healthy volunteers: Not accepted

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 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

Conditions

• Thalassemia

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	Zinc	25 mg of elemental zinc as zinc sulphate take 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

Timeline

• Start date: 2006-04-01
• Primary completion: 2009-10-01
• Completion: 2011-02-01
• First posted: 2007-04-12
• Last updated: 2020-12-04
• Results posted: 2011-09-30

Locations

3 sites across 1 country: United States