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NCT01166815 · ClinicalTrials.gov registry record · Phase 2
Zinc Supplementation to Reduce Diarrhea Rates in Adults in Western Kenya.
A Phase 2 study, sponsored by United States Army Research Institute of Environmental Medicine.
- Completed
- Registry status
- Phase 2
- Development phase
- 500
- Enrollment target
NCT01166815 is a Phase 2 study that has completed, run by United States Army Research Institute of Environmental Medicine. The registered enrollment target is 500 participants.
The verdict
NCT01166815, a Phase 2 study, has completed, sponsored by United States Army Research Institute of Environmental Medicine.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 500 participants
- Enrollment target
Study Summary
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.
Interventions
- OTHER Placebo
- DIETARY_SUPPLEMENT Zinc sulphate
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 500 participants |
| Start Date | 2007-07 |
| Est. Completion | 2008-01 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01166815
The ClinicalTrials.gov registry entry for NCT01166815 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 500 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is United States Army Research Institute of Environmental Medicine, which has 59 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT01166815 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01166815 about?
NCT01166815 is a clinical study titled "Zinc Supplementation to Reduce Diarrhea Rates in Adults in Western Kenya.". 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 ob...
What is the current status of trial NCT01166815?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 500 participants. The study started on 2007-07. Estimated completion is 2008-01.
What interventions are being tested in trial NCT01166815?
The interventions under investigation include: Placebo (OTHER), Zinc sulphate (DIETARY_SUPPLEMENT).
Who is sponsoring clinical trial NCT01166815?
This trial is sponsored by United States Army Research Institute of Environmental Medicine, which has 59 total clinical trials registered on ClinicalTrials.gov.
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