Abstract
ObjectiveTo examine whether daily zinc and/or multivitamin supplementation reduce biomarkers of environmental enteric dysfunction (EED), systemic inflammation, or markers of growth in a sample of infants from Dar es Salaam, Tanzania.Study designSubgroup analysis of infants participating in a randomized, double-blind, placebo-controlled trial received daily oral supplementation of zinc, multivitamins, zinc + multivitamins, or placebo for 18 months starting at 6 weeks of age. EED (anti-flagellin and anti-lipopolysaccharide immunoglobulins), systemic inflammation (C-reactive protein and alpha-1-acid glycoprotein), and growth biomarkers (insulin-like growth factor-1 and insulin-like growth factor binding protein-3) were measured via enzyme-linked immunosorbent assay in a subsample of 590 infants at 6 weeks and 6 months of age. EED biomarkers also were measured in 162 infants at 12 months of age.ResultsWith the exception of anti-lipopolysaccharide IgG concentrations, which were significantly greater in infants who received multivitamins compared with those who did not (1.41 ± 0.61 vs 1.26 ± 0.65, P = .006), and insulin-like growth factor binding protein-3 concentrations, which were significantly lower in children who received zinc compared with those who did not (981.13 ± 297.59 vs 1019.10 ± 333.01, P = .03), at 6 months of age, we did not observe any significant treatment effects of zinc or multivitamins on EED, systemic inflammation, or growth biomarkers.ConclusionsNeither zinc nor multivitamin supplementation ameliorated markers of EED or systemic inflammation during infancy. Other interventions should be prioritized for future trials.Trial registrationClinicaltrials.gov: NCT00421668.
Highlights
Systemic inflammation is thought to be both a cause and consequence of environmental enteric dysfunction (EED), a disorder of the small intestine characterized by alterations in the structure and function of the gut, mucosal inflammation, villous blunting, altered barrier integrity, and reduced absorptive capacity, due to exposure to unhygienic conditions.[6,7,8]
Both EED and systemic inflammation biomarkers have been linked to poor child
With the exception of insulin-like growth factor binding protein-3 (IGFBP-3) concentrations at 6 months of age we did not observe any significant differences in biomarker concentrations of EED, systemic inflammation, or growth in infants who received zinc compared with infants who did not receive zinc at any of the assessed time points (P 3 .05 for all)
Summary
Infants in this study were participants in a double-blind, placebo-controlled trial (NCT00421668) with a 2 by 2 factorial design (n = 2400) that was conducted between August 2007 and May 2011 in peri-urban Dar es Salaam, Tanzania. The primary objective of the parent trial was to determine whether the daily administration of zinc and/or multivitamins reduced the risk of infectious morbidity compared with a placebo. For purposes of randomization into the parent trial, a biostatistician in Boston prepared a list from 1 to 2400 that used blocks of 20 and was stratified by study clinic. Infants of multiple births and with congenital anomalies that would interfere with the study procedures were excluded from the parent trial. Mothers and infants enrolled in the parent trial were followed for 18 months from randomization or until death or loss to follow-up
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