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Clinical trialNCT01166815CompletedPhase 2/PHASE3Interventional

Zinc Supplementation to Reduce Diarrhea Rates in Adults in Western Kenya.

SponsorUnited States Army Research Institute of Environmental MedicineEnrollment500DiarrheaMalaria
View the registry record on ClinicalTrials.gov

Summary

The lay summary the sponsor registered on ClinicalTrials.gov.

Zinc deficiency is prevalent in children in developing countries. Zinc-supplementation is proven to reduce the duration and severity of childhood diarrhea in randomized controlled trials. However, despite this evidence, its efficacy to reduce diarrhea morbidity in adults remains unknown. The main objective of this study is to determine the efficacy of Zn-supplementation on diarrhea incidences in a vulnerable adult population. The study will be carried out in Kombewa division, Kisumu District and will involve 500 adults aged 18-55 years. They will be randomly assigned to receive Zn supplement (or placebo) on a daily basis over a 3 month period. Morbidity information will be collected daily for 4 months, while anthropometric measures and laboratory data will be obtained at study onset, end of supplementation and study conclusion. In addition, HIV and malaria tests will be carried out during the study as they are important confounders. The significant differences in diarrhea incidence between the Zn-group and the placebo-group will be determined using SPSS. The results are expected to provide the scientific basis and common pathway for development of an anti-diarrheal supplement for vulnerable populations such as environmental refugees, deprived and displaced persons, and troops prior to deployment.

Investigators

The overall officials registered on this study. Names that resolve to a findmyKOL profile link to it; the rest are shown as registered.

  • Lucas Otieno, MB.ChB

    Kenya Medical Research Institute (KEMRI)/Walter Reed Project (WRP), Kisumu, Kenya

    Principal Investigator
  • Maria E Bovill, Dr.PH

    U.S. Army Medical Research Unit - Kenya (USAMRU-K), Kisumu, Kenya

    Principal Investigator
  • Mark E Polhemus, MD

    U.S. Army Medical Research Unit - Kenya (USAMRU-K), Kisumu, Kenya

    Principal Investigator
  • Stella K Apollo, BSN

    Walter Reed Project (WRP), Kisumu, Kenya

    Study Director

A profile link is shown only when the registered name resolves to a person record with a confident, namesake-checked match; ambiguous names stay unlinked.

Sites

3 registered facilities, with the per-site recruitment status where the registry publishes one. ClinicalTrials.gov does not publish per-site enrollment counts.

Kenya
  • Kombewa Clinical Research Center

    Kombewa, Kisumu West, Kenya

United States
  • U.S. Army Research Institute of Environmental Medicine (usariem)

    Natick, Massachusetts, United States

  • U.S. Department of Agriculture, Agricultural Research Service, Grand Forks Human Nutrition Center

    Grand Forks, North Dakota, United States

Site investigator names are published by ClinicalTrials.gov only while a study recruits, so completed studies list sites without them.

Drugs studied

No drug or biological interventions are in our data for this study. It may test a procedure, device or behavioral intervention, or the intervention list isn't in our current snapshot. See the registry record ↗. Why? →

Registration & key dates

Registry attributes as recorded on the ClinicalTrials.gov study record.

Start
31 Jul 2007
Primary completion
31 Jan 2008
Completion
31 Jan 2008
Last update posted
22 Jul 2010
Registered enrollment
500
Registry id
NCT01166815

Source: ClinicalTrials.gov, via the CTTI AACT database, data as of 24 Aug 2026. Registry facts are shown as registered by the study sponsor; findmyKOL does not interpret them.