Project Number: 5450-51530-009-10
Project Type: Reimbursable

Start Date: Oct 01, 2007
End Date: Sep 30, 2008

Objective:
ARS will receive blood samples and measure blood biochemical indicators of iron, zinc, selenium nutritional status and indicators of inflammation of human volunteers. ARS will ship samples for vitamin A and retinol-binding protein to Pennington Research Center where USARIEM has a contract to run their blood chemistries. ARS will provide the results of analytical tests to US Army Research Institute of Environmental Medicine (USARIEM) co-investigators. USARIEM will recruit human volunteers, randomize volunteers to treatment groups, and provide supplements and placebo treatments. USARIEM will obtain, prepare and ship blood samples to ARS. USARIEM will recruit and train field research associates who will collect data on diarrhea incidence and symptoms. USARIEM collaborators will evaluate the effects of zinc supplementation on clinical assessments of diarrhea and some potential mediating factors. ARS and USARIEM jointly will participate in interpretation of findings and preparation of reports and manuscripts.

Approach:
The study will use a double-blind (observer blind and volunteer blind), randomized controlled design (randomization ratio 1:1) of supplemental zinc (20 mg/d) compared to placebo (maltodextrin) for five months. Randomization will include a total of 500 eligible adults matched by sex and age (18 to 55 years) and living in Western Kenya. This field research will be supervised and coordinated by investigators of the US Army Medical Research Unit ¿ Kenya (USAMRU-K) and the Kenya Medical Research Institute (KEMRI)/Walter Reed Project (WRP), and conducted at the Kombewa Clinical Research Center (KCRC) outside of Kisumu in Western Kenya. This study will test the hypothesis that zinc supplementation reduces the incidence and symptoms of diarrhea and decreases presence of bacterial vectors associated with diarrhea.