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A Novel Bio-marker of Zinc Status

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01062347
Recruitment Status : Completed
First Posted : February 4, 2010
Last Update Posted : June 7, 2017
University of California, Davis
Information provided by:
International Centre for Diarrhoeal Disease Research, Bangladesh

Brief Summary:
Zinc deficiency is a widespread public health problem in developing countries. The true prevalence of this condition remains uncertain because of lack of a specific, sensitive and reliable biomarker for assessment of human zinc status. The most widely used indicator for measuring zinc status is serum zinc level, which, however, is homeostatically regulated and influenced by stress and infection. To explore the possibility of using mRNA levels of zinc responsive genes as an indicator of zinc status, Cao and Cousins suggested metallothionein (MT) mRNA level in monocytes and peripheral blood mononuclear cells as an indicator of recent zinc uptake. However, the usefulness of MT mRNA is also limited because its level is influenced by other metals, such as copper, cadmium and cobalt and it is also affected by stress. Several authors have proposed that expression of zinc transporter genes might be useful markers of Zn status. Evidence shows reduction in dietary zinc content produces a marked increase in intestinal absorption and decrease in intestinal zinc losses. As zinc homeostasis is regulated in the intestine, study of the zinc transporters in this organ may provide indication of recent zinc uptake. Recently, a few studies have begun to investigate the applicability of using white blood cell zinc transporter expression as an indicator of zinc status and found that some of the transporters are zinc responsive. The primary objective of this study is to explore whether the expression of zinc responsive genes, such as zinc transporters in human intestinal mucosal cells, can be used as indicators of zinc status. The specific aims are to compare gene expression in: a) intestinal mucosal cells obtained by duodenal biopsy, b) sloughed intestinal mucosal cells isolated from feces, and c) peripheral blood mononuclear cells (PBMC) in fasting individuals who are receiving their usual diet + placebo or their usual diet + supplemental zinc (20 mg/d for 7 days). Gene expression values from intestinal mucosal cells (biopsy) will be compared between the placebo and zinc supplemented groups. Similar comparison will be done in the cells isolated from stool and PBMCs. This study will also provide an opportunity to compare the relative responsiveness of gene expression and serum zinc concentration following supplementation and to explore the kinetics of any changes in serum zinc concentration. Thus, blood samples will be obtained for measuring serum zinc concentration on two occasions prior to the interventions and at specified intervals during and after the intervention.

Condition or disease Intervention/treatment Phase
Zinc Deficiency Biological: Zinc Phase 1

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Study Type : Interventional  (Clinical Trial)
Official Title: Exploring the Possibility of Using Intestinal mRNA Levels of Zinc Transporter Genes, and Changes in Their Expression Levels in Response to Zinc Supplementation as a Bio-marker for Zinc Status
Actual Study Start Date : July 1, 2007
Actual Primary Completion Date : December 31, 2010
Actual Study Completion Date : December 31, 2010

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: zinc supplementation (20 mg/d, for 7 d) Biological: Zinc

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 35 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

  • Healthy, non-smoking

Exclusion Criteria:

  • Suffering from diarrhea

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01062347

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Dhaka, Bangladesh
Sponsors and Collaborators
International Centre for Diarrhoeal Disease Research, Bangladesh
University of California, Davis

Additional Information:
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Responsible Party: Mohammad Bakhtiar Hossain, ICDDR,B Identifier: NCT01062347     History of Changes
Other Study ID Numbers: 2006-004
First Posted: February 4, 2010    Key Record Dates
Last Update Posted: June 7, 2017
Last Verified: February 2010
Keywords provided by International Centre for Diarrhoeal Disease Research, Bangladesh:
To identify a new bio-marker for zinc status
Additional relevant MeSH terms:
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Trace Elements
Growth Substances
Physiological Effects of Drugs