Status:
COMPLETED
Zinc Supplementation to Reduce Diarrhea Rates in Adults in Western Kenya.
Lead Sponsor:
United States Army Research Institute of Environmental Medicine
Collaborating Sponsors:
Walter Reed Army Institute of Research (WRAIR)
Conditions:
Diarrhea
Malaria
Eligibility:
All Genders
18-55 years
Phase:
PHASE2
PHASE3
Brief 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, des...
Detailed Description
Diarrhea has been a major cause of morbidity, hospitalization, and loss of duty days for military personnel for centuries. In fact, diarrheal illness is the most common medical problem for U.S. troops...
Eligibility Criteria
Inclusion
- Male or female between 18 and 55 years of age
- Written informed consent obtained from the volunteer in Dholuo, Kiswahili or English.
- Available to participate for the study duration (approximately five months)
- Negative pregnancy test at screening and study start
- Not taking any vitamin/mineral supplements for the last 2 months prior to onset of the study.
Exclusion
- Profound clinical evidence of current immunosuppression or evidence of active AIDS defining illness
- A family history of congenital or hereditary immunodeficiency
- History of allergic reactions to zinc
- History of any neurologic disorders or seizures
- Acute or chronic, clinically significant pulmonary, cardiovascular, hepatic, renal functional abnormality, as determined by physical examination or laboratory screening tests
- ALT above normal range: \>60 U/L Male; \>40 U/L Female
- Creatinine above normal range: \>1.5 mg/dL
- Hemoglobin below normal range: \<11.0 g/dL Male; \<9.5 g/dL Female
- Total White Cell Count below normal range \<3.0 x 103/uL Male; \<2.5 x 103/uL Female
- Absolute lymphocyte count \< 1.0 x 103/uL
- Platelet count below normal range \<100 x 103/uL
- Pregnant female (positive pregnancy test) at time of screening or study start
- History of chronic alcohol consumption and/or drug abuse
- Use of any investigational or non-registered drugs or vaccines within 30 days preceding the first dose of the study, or planned use during the study period
- Any chronic drug therapy to be continued during the study period
- Simultaneous participation in any other clinical trial
- Planning to start or unable to discontinue vitamin/mineral supplements other than those supplied by the study
- HIV positive with current Aids defining illness or CD4 count less than 250 cells/mm3
- Any other findings that the investigator feels would increase the risk of having an adverse outcome from participation in the trial
- Persons having diarrhea at the time of enrollment.
Key Trial Info
Start Date :
July 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2008
Estimated Enrollment :
500 Patients enrolled
Trial Details
Trial ID
NCT01166815
Start Date
July 1 2007
End Date
January 1 2008
Last Update
July 22 2010
Active Locations (3)
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1
U.S. Army Research Institute of Environmental Medicine (USARIEM)
Natick, Massachusetts, United States, 01760
2
U.S. Department of Agriculture, Agricultural Research Service, Grand Forks Human Nutrition Center
Grand Forks, North Dakota, United States, 56721
3
Kombewa Clinical Research Center
Kombewa, Kisumu West, Kenya