Effect of Zinc on Barrett's Metaplasia
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|ClinicalTrials.gov Identifier: NCT01984580|
Recruitment Status : Unknown
Verified November 2013 by James M. Mullin, Ph.D., Main Line Health.
Recruitment status was: Recruiting
First Posted : November 14, 2013
Last Update Posted : November 14, 2013
Using orally administered zinc to patients already diagnosed with the pre-cancerous condition, Barrett's Esophagus, this study is asking two questions:
- can this zinc administration cause molecular-level changes in the Barrett's tissue?
- are the changes measured indicative of chemopreventive action by zinc regarding cancer progression?
|Condition or disease||Intervention/treatment||Phase|
|Barrett's Metaplasia||Drug: zinc gluconate||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||120 participants|
|Intervention Model:||Parallel Assignment|
|Official Title:||Effect of Zinc on Barrett's Metaplasia|
|Study Start Date :||April 2011|
|Estimated Primary Completion Date :||March 2015|
|Estimated Study Completion Date :||December 2015|
Drug: zinc gluconate
26.6 mg zinc BID (as zinc gluconate)
|Placebo Comparator: sodium|
- Changes in zinc-regulated cellular proteins within Barrett's tissue [ Time Frame: in biopsy tissue after 14 days of Zn exposure ]
- Changes in cellular microRNA profile; changes in protein cancer biomarkers [ Time Frame: in biopsy tissue after 14 days of Zn exposure ]
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 ClinicalTrials.gov identifier (NCT number): NCT01984580
|Contact: James M Mullin, Ph.D.||firstname.lastname@example.org|
|United States, Pennsylvania|
|Lankenau Institute for Medical Research||Recruiting|
|Wynnewood, Pennsylvania, United States, 19096|