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

Completed · Phase 2/Phase 3 · Has a placebo group

Conditions studied: Diarrhea, Malaria

In brief

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.

Key facts

Study ID

NCT01166815

Run by

United States Army Research Institute of Environmental Medicine

People needed

500

Starts

2007-07-01

Expected to finish

2008-01-01

Last updated by the study team

2010-07-22

Who can join

Age: 18 and older, up to 55. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• 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
• Kombewa Clinical Research Center — Kombewa, Kisumu West, Kenya

Full record on ClinicalTrials.gov

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