An Evaluation of Zinc Status Biomarkers
Testing Novel Biomarkers of Zinc Status for Use in Human Zinc Supplementation Trials
1 other identifier
interventional
18
1 country
1
Brief Summary
The purpose of this study is to determine the effect of a moderate decrease in dietary zinc on DNA strand breaks and other cellular zinc biomarkers.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Mar 2011
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2015
CompletedFirst Submitted
Initial submission to the registry
August 4, 2016
CompletedFirst Posted
Study publicly available on registry
August 10, 2016
CompletedNovember 24, 2020
November 1, 2020
2.9 years
August 4, 2016
November 20, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change in the percent of leukocytic DNA strand breaks
Baseline measurements were made upon entry into the study. Subsequent measurements were made after 2 weeks on a low zinc diet (6 mg/d), 4 weeks on a moderate zinc intake (10 mg/d) and after 3 weeks of consuming a 25 mg zinc supplement.
Change in DNA strand breaks measured at baseline, 2, 4, and 3 week intervals with changes in diet zinc
Secondary Outcomes (1)
Cellular zinc biomarkers
At baseline and at 3 time points during the 9 week study: after 2, 6, and 9 weeks.
Study Arms (1)
diet zinc
EXPERIMENTAL3 dietary zinc levels: 6 mg/d, 10 mg/d and 25 mg supplemental zinc/d
Interventions
4 mg zinc, as zinc sulfate, was added to a controlled diet; 25 mg supplemental zinc was given during the final recovery period when an ad lib diet was consumed
Eligibility Criteria
You may qualify if:
- willing to limit food and beverage intake to that provided by the study
- willing to discontinue consumption of alcoholic beverages during the study
- has an operative understanding of English
- no plans to move from the area during the study period
You may not qualify if:
- chronic or acute metabolic disease (i.e., diabetes or asthma)
- taking medications for a metabolic disorder
- evidence of alcohol abuse or use of illicit drugs
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Children's Hospital Oakland Research Institute
Oakland, California, 94609, United States
Related Publications (1)
Zyba SJ, Shenvi SV, Killilea DW, Holland TC, Kim E, Moy A, Sutherland B, Gildengorin V, Shigenaga MK, King JC. A moderate increase in dietary zinc reduces DNA strand breaks in leukocytes and alters plasma proteins without changing plasma zinc concentrations. Am J Clin Nutr. 2017 Feb;105(2):343-351. doi: 10.3945/ajcn.116.135327. Epub 2016 Dec 21.
PMID: 28003206DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Janet C King, Ph.D.
UCSF Benioff Children's Hospital Oakland
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- OTHER
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 4, 2016
First Posted
August 10, 2016
Study Start
March 1, 2011
Primary Completion
February 1, 2014
Study Completion
February 1, 2015
Last Updated
November 24, 2020
Record last verified: 2020-11
Data Sharing
- IPD Sharing
- Will not share