None listed
Conditions
Brief summary
The project is evaluating the impact of vitamin A and zinc supplementation on the on the epidemiology and clinical history of bacterial, parasitic and viral diarrheal pathogen infections among children living in marginalized communities of Mexico City. The study hypothesis is that these two micronutrient supplements will have distinct and contrasting effects on pathogen infections compared to children in the placebo group. The project was randomized, double-blind, placebo-controlled trial that was carried out among 800 children 6-15 mo. of age in peri-urban areas of Mexico City from 2000 to 2003. Enrolled children were assigned to either a group receiving vitamin A every two months, a group receiving a daily zinc supplement, a group receiving both the zinc and vitamin A supplements, or a placebo group. Stools collected once a month and following diarrheal episodes from children in the 12 month follow-up are being screened for diarrheal E. coli, enteric viral pathogens and helminthes and gut protozoa. Pathogen-specific diarrhoeal rates among children in the different treatment arms and placebo group are now being compared in the 707 children who remained in the study.
Interventions
Children were assigned to 1 of 4 groups: 1) a vitamin A group that received 20 000 IU retinol every 2 mo for children aged <1 y or 45 000 IU for children aged >1 y, 2) a group that received a daily dose equivalent to 20 mg elemental Zn as zinc methionine, 3) a group that received both the zinc supplement and the vitamin A supplement as above, and 4) a placebo group and followed for 12 months. The vitamin A, zinc, and vitamin A - zinc supplements were prepared by personnel at the National Instit
Children were assigned to 1 of 4 groups: 1) a vitamin A group that received 20 000 IU retinol every 2 mo for children aged <1 y or 45 000 IU for children aged >1 y, 2) a group that received a daily dose equivalent to 20 mg elemental Zn as zinc methionine, 3) a group that received both the zinc supplement and the vitamin A supplement as above, and 4) a placebo group and followed for 12 months. The vitamin A, zinc, and vitamin A - zinc supplements were prepared by personnel at the National Institute of Nutrition in 5-mL solutions that contained the supplements were similar in taste and appearance. Children in the placebo or control (sham) group received the same solution without any supplement. These solutions were packaged in consecutively numbered, color-coded, opaque plastic droplet bottles. During the 12-mo follow-up period, field personnel administered the solution containing the respective supplements twice a week to all children in the 3 treatment arms and placebo group and left bottles for the remaining days of the week with instructions on how to administer the solution.
Sponsors
University of Queensland
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Prevention
Masking
Blinded (masking used)
Eligibility
Sex/Gender
All
Age
6 Months to 15 Months
Healthy volunteers
Yes
Inclusion criteria
Children 6-15 months of age living in peri-urban communities of Mexico City
Exclusion criteria
Children with immuno-suppression or any congenital or acquried alteration of the digestive tract that could alter the absorption of micronutrients were excluded. Children were also excluded when they had received a vitamin A supplement from a source outside the project.
Outcome results
None listed