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Zinc to Improve Bone Health in People With Thalassemia (The Think Zinc Study)
This study is ongoing, but not recruiting participants.
First Received: May 29, 2007   Last Updated: February 18, 2009   History of Changes
Sponsors and Collaborators: National Heart, Lung, and Blood Institute (NHLBI)
Children's Hospital & Research Center Oakland
Children's Hospital of Philadelphia
University of California, San Francisco
Information provided by: National Heart, Lung, and Blood Institute (NHLBI)
ClinicalTrials.gov Identifier: NCT00480415
  Purpose

Many people with the blood disorder thalassemia also have osteoporosis, possibly caused by low zinc levels. This study will evaluate the effectiveness of zinc supplements at improving bone health in individuals with thalassemia.


Condition Intervention Phase
Thalassemia
Dietary Supplement: Zinc Supplements
Phase II

Genetics Home Reference related topics: beta thalassemia
MedlinePlus related topics: Dietary Supplements Minerals Thalassemia
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator), Placebo Control, Parallel Assignment, Efficacy Study
Official Title: Zinc and Bone Metabolism in Thalassemia

Further study details as provided by National Heart, Lung, and Blood Institute (NHLBI):

Primary Outcome Measures:
  • Change in lumbar spine bone mineral density (BMD) and whole body bone mineral content (BMC) by dual-energy x-ray absorptiometry (DXA) [ Time Frame: Measured at Months 12 and 18 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Changes in specific markers of bone turnover [ Time Frame: Measured at Months 3, 6, 12 and 18 ] [ Designated as safety issue: No ]
  • Changes in growth parameters (for those who have not reached adult height) [ Time Frame: Measured at Months 3, 6, 12 and 18 ] [ Designated as safety issue: No ]
  • Changes in body composition by whole body DXA scans [ Time Frame: Measured at Months 12 and 18 ] [ Designated as safety issue: No ]

Estimated Enrollment: 60
Study Start Date: April 2006
Estimated Study Completion Date: December 2009
Estimated Primary Completion Date: September 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
I: Experimental
n/a
Dietary Supplement: Zinc Supplements
25 mg/day of zinc as zn sulfate

Detailed Description:

Thalassemia is an inherited blood disorder that causes mild to severe anemia. In people with thalassemia, an abnormal or missing gene impairs the body's ability to make hemoglobin, a red blood cell protein that carries oxygen. Many individuals with this disease also have osteoporosis, which is likely caused by a combination of factors, including disease state, hormones, and nutrition. The nutrient zinc plays an important role in bone strength and is often deficient in people with thalassemia. The most effective way to prevent osteoporosis is to build strong, dense bones early in life. Correcting low zinc levels at an early age may prevent the onset of osteoporosis in people with thalassemia. The purpose of this study is to evaluate the effectiveness of zinc supplements in improving bone health in young individuals with thalassemia.

This 18-month study will enroll children and young adults with thalassemia and low bone mass. Participants will be randomly assigned to receive either 25 mg of zinc or placebo daily. Study visits will occur at baseline and Months 3, 6, 12, and 18. Each visit will include height, weight, and body fat measurements; blood and urine collection; and a health questionnaire. At baseline and Months 12 and 18, bone density will be measured with x-rays, and a food frequency questionnaire will be completed. At the baseline study visit, participants less than 21 years of age will have x-ray images taken of their hand to assess bone age, which is the degree of maturation of their bones. Study staff will monitor medication adherence through pill counts.

  Eligibility

Ages Eligible for Study:   6 Years to 30 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Diagnosed with thalassemia
  • Bone mineral density Z-score less than -1.0 by DXA

Exclusion Criteria:

  • Bone marrow transplant recipient
  • Currently taking medication for low bone mass (e.g., bisphosphonates)
  • Currently taking zinc supplements and unable or unwilling to stop for the duration of the study
  • Currently participating in another clinical trial that is studying a medication known to affect BMD
  • Prolonged use of systemic corticosteroids
  • Growth hormone deficiency
  • Serum copper level less than 70 ug/dL at baseline
  • Serum 25-OH vitamin D level less than 11 ng/mL
  • Pregnant
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00480415

Locations
United States, California
Children's Hospital & Research Center Oakland
Oakland, California, United States, 94609
University of California, San Francisco
San Francisco, California, United States, 94143
United States, Pennsylvania
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, United States, 19104
Sponsors and Collaborators
Children's Hospital & Research Center Oakland
Children's Hospital of Philadelphia
University of California, San Francisco
Investigators
Principal Investigator: Ellen B. Fung, PhD, RD Children's Hospital & Research Center Oakland
Study Director: Elliott Vichinsky, MD Children's Hospital & Research Center Oakland
  More Information

No publications provided

Responsible Party: Children's Hospital & Research Center, Oakland ( Ellen Fung, PhD RD; Assistant Research Scientist )
Study ID Numbers: 484, K23 HL076468
Study First Received: May 29, 2007
Last Updated: February 18, 2009
ClinicalTrials.gov Identifier: NCT00480415     History of Changes
Health Authority: United States: Federal Government

Keywords provided by National Heart, Lung, and Blood Institute (NHLBI):
Zinc
Bone Mineral Density

Study placed in the following topic categories:
Anemia, Hemolytic, Congenital
Genetic Diseases, Inborn
Hematologic Diseases
Hemoglobinopathies
Zinc
Anemia
Anemia, Hemolytic
Trace Elements
Micronutrients
Hemoglobinopathy
Thalassemia

Additional relevant MeSH terms:
Hematologic Diseases
Growth Substances
Physiological Effects of Drugs
Anemia
Anemia, Hemolytic
Trace Elements
Thalassemia
Pharmacologic Actions
Anemia, Hemolytic, Congenital
Genetic Diseases, Inborn
Hemoglobinopathies
Zinc
Micronutrients

ClinicalTrials.gov processed this record on May 07, 2009