Try our beta test site
IMPORTANT: Listing of a study on this site does not reflect endorsement by the National Institutes of Health. Talk with a trusted healthcare professional before volunteering for a study. Read more...

Zinc and Diabetes in Patients With Thalassemia: a Pilot Study

This study has been completed.
Information provided by (Responsible Party):
Ellen B. Fung, Children's Hospital & Research Center Oakland Identifier:
First received: January 17, 2013
Last updated: November 25, 2015
Last verified: November 2015
The primary aim of this study is to measure zinc status and related proteins in patients with Thalassemia who have or do not have diabetes. The secondary aim will be to explore the effect of zinc supplementation on glucose metabolism in patients with thalassemia.

Condition Intervention Phase
Dietary Supplement: Zinc Supplementation
Phase 1

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Official Title: Zinc and Diabetes in Patients With Thalassemia: a Pilot Study

Resource links provided by NLM:

Further study details as provided by Ellen B. Fung, Children's Hospital & Research Center Oakland:

Primary Outcome Measures:
  • Oral glucose Tolerance Test [ Time Frame: 3 months ]
    Effect of 3 months of zinc supplementation on oral glucose tolerance test results

Secondary Outcome Measures:
  • Fructosamine [ Time Frame: 3 months ]
    Determine the effect of 3 months of zinc supplementation on fructosamine levels

Enrollment: 40
Study Start Date: November 2012
Study Completion Date: May 2015
Primary Completion Date: January 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Zinc Supplementation
25 mg elemental Zinc as Zn sulfate in capsule form taken daily for 3 months
Dietary Supplement: Zinc Supplementation
25 mg elemental zinc taken as zinc sulfate in capsule form taken daily for 3 months

Detailed Description:

Patients with Thalassemia major (Thal) require frequent blood transfusions and are at risk for iron overload. High tissue iron increases the risk of various endocrinopathies, including diabetes, as well as cardiovascular disease, and infections due to the formation of free radicals. This systemic condition of oxidative stress elicits an antioxidant response to reduce tissue damage. Zinc is an important component of that response because it can compete with iron for multiple cellular binding sites and, therefore, reduce the redox-cycling of iron and minimize iron-mediated oxidation of lipids, proteins, and DNA.

In Thal patients with chronic hepatic iron overload, tissue zinc redistribution is likely to be persistent. This could create an unbalanced tissue zinc distribution with excessive amounts in the liver and deficient levels in other tissues altering zinc-dependent functions, such as growth, skeletal development, immunity, and glucose regulation. There is a rich body of literature focused on the 'diabetogenic effects' of altered zinc status which will be reviewed herein. Our group has recently shown that supplementation with 25 mg/d of zinc can improve bone density in patients with Thal. This provides evidence for a functional zinc deficiency, which may also affect other whole body zinc functions, such as insulin secretion and glucose homeostasis.

Our hypothesis is that hepatic iron overload induces a sub-clinical inflammatory response that alters the expression of MT and zinc-transport proteins leading to hepatic zinc sequestration, and an associated zinc-depletion in other tissues. Marginal zinc depletion in turn leads to increased oxidative stress, cellular apoptosis and altered glucose homeostasis and insulin secretion. This proposal will focus on cross-sectional differences in markers of glucose homeostasis and zinc status in diabetic and non-diabetic Thal patients, combined with a short- term zinc supplementation to explore the effect on glucose and insulin homeostasis.


Ages Eligible for Study:   12 Years and older   (Child, Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

  • patients diagnosed with transfusion dependent thalassemia
  • > 12 years of age

Exclusion Criteria (for both cross-sectional and interventional studies)

  • patients who are pregnant
  • patients who are on growth hormone therapy

Exclusion criteria (for intervention study only)

  • patients who currently have diabetes (therefore cannot have an oral glucose tolerance test)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01772680

United States, California
Children's Hospital & Research Center Oakland
Oakland, California, United States, 94609
Sponsors and Collaborators
Children's Hospital & Research Center Oakland
Principal Investigator: Ellen B Fung, PhD RD Children's Hospital & Research Center Oakland
  More Information

Responsible Party: Ellen B. Fung, Associate Research Scientist, Children's Hospital & Research Center Oakland Identifier: NCT01772680     History of Changes
Other Study ID Numbers: 2012-071
Study First Received: January 17, 2013
Last Updated: November 25, 2015

Keywords provided by Ellen B. Fung, Children's Hospital & Research Center Oakland:

Additional relevant MeSH terms:
Anemia, Hemolytic, Congenital
Anemia, Hemolytic
Hematologic Diseases
Genetic Diseases, Inborn
Trace Elements
Growth Substances
Physiological Effects of Drugs processed this record on May 25, 2017