Zinc & Bone Health in Thalassemia: The Think Zinc Study

Thalassemia Clinical Trial

— ThinkZn  

Official title:

Zinc and Bone Metabolism in Thalassemia

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00459732
• Other study ID #: 2004-106
• Secondary ID: K23HL076468
• Status: Completed
• Phase: N/A
• Start date: April 2006
• Est. completion date: February 2011

Study information

• Verified date: December 2020
• Source: UCSF Benioff Children's Hospital Oakland
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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

Other known NCT identifiers

• NCT00480415

Recruitment information / eligibility

• Status: Completed
• Enrollment: 45
• Est. completion date: February 2011
• Est. primary completion date: October 2009
• Accepts healthy volunteers: No
• Gender: All
• Age group: 6 Years to 30 Years

Eligibility

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

Related Conditions & MeSH terms

• Thalassemia

Intervention

Dietary Supplement:
• Zinc
25 mg of elemental zinc as zinc sulphate take once daily for 18 months
• Placebo
Placebo capsule, identical to the zn capsule in size, shape and color, taken once daily for 18 months

Locations

Country	Name	City	State
United States	Children's Hospital & Research Center, Oakland	Oakland	California
United States	Children's Hospital of Philadelphia	Philadelphia	Pennsylvania
United States	University of California, San Francisco	San Francisco	California

Sponsors (4)

Lead Sponsor	Collaborator
UCSF Benioff Children's Hospital Oakland	Children's Hospital of Philadelphia, National Heart, Lung, and Blood Institute (NHLBI), University of California, San Francisco

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Lumbar Spine Bone Mineral Density (BMD) by DXA (Baseline to 18 Months)	Change in pa spine bone mineral density by DXA between baseline and 18 months	0 to 18 months
Primary	Change in Whole Body Bone Mineral Content (BMC) by DXA (Baseline to 18 Months)		Baseline to 18 months
Secondary	Osteocalcin, a Marker of Bone Formation	Absolute change in serum osteocalcin between 0 and 18 months, intention to treat analysis between the zinc and placebo groups	Baseline to 18 months