Zinc & Bone Health in Thalassemia: The Think Zinc Study

Not Applicable

Completed

Conditions: Thalassemia

Interventions: Dietary Supplement: Placebo
Dietary Supplement: Zinc

Registration Number: NCT00459732

Lead Sponsor: UCSF Benioff Children's Hospital Oakland

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 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

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 45

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

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo Capsule	Placebo	placebo capsule, similar in size, shape and color to zinc capsule, taken once daily for 18 months
Zinc (25 mg/d)	Zinc	25 mg of elemental Zinc as zinc sulphate taken once daily for 18 months

Primary Outcome Measures

Name	Time	Method
Change in Lumbar Spine Bone Mineral Density (BMD) by DXA (Baseline to 18 Months)	0 to 18 months	Change in pa spine bone mineral density by DXA between baseline and 18 months
Change in Whole Body Bone Mineral Content (BMC) by DXA (Baseline to 18 Months)	Baseline to 18 months

Secondary Outcome Measures

Name	Time	Method
Osteocalcin, a Marker of Bone Formation	Baseline to 18 months	Absolute change in serum osteocalcin between 0 and 18 months, intention to treat analysis between the zinc and placebo groups

Trial Locations

Locations (3): Children's Hospital & Research Center, Oakland
🇺🇸
Oakland, California, United States
University of California, San Francisco
🇺🇸
San Francisco, California, United States
Children's Hospital of Philadelphia
🇺🇸
Philadelphia, Pennsylvania, United States