Location: Immunity and Disease Prevention Research
Project Number: 2032-53000-001-13-T
Project Type: Trust Fund Cooperative Agreement
Start Date: Jun 1, 2014
End Date: Mar 31, 2019
This is a zinc intervention trial in infants at risk of zinc deficiency. The principal objective is to determine if daily zinc supplementation improves immune function relative to no supplementation or periodic supplementation as a therapeutic treatment for diarrhea. There are two specific aims: (1) determine if the concentration of cytokine produced by cultures of peripheral blood white blood cells (WBC) differs by group at baseline and at one time point near the end of the intervention; and (2) determine if the concentrations of naïve (CD45RA+) and memory (CD45RO+) CD4 and CD8 T-cells and regulatory (Treg) T-cells (CD25+CD127low) and compare among the groups.
A four-group zinc intervention trial in 3,400 children (850 per group) 6-23 months of age at enrollment will be conducted in Laos with collaborators from the University of California, Davis, Khon Kaen University in Thailand, and the Laos Ministry of Health. The four groups will be: (1) daily preventive zinc tablets (7 mg zinc/d) + placebo tablets and ORS for diarrhea; (2) daily placebo tablets + zinc tablets (20 mg zinc/d X 10 d) and ORS for diarrhea; (3) daily MMN powder containing 10 mg zinc + placebo tablets and ORS for diarrhea; and (4) daily placebo MMN powder + placebo tablets and ORS for diarrhea. The enrollment and sample collection/processing period will be two years. Blood will be collected at the beginning and end of the nine-month zinc intervention period and will be processed by technicians near the field site in Laos and at Khon Kaen University. Samples will be sent to Davis for analysis of cytokine levels.