Background: The necessity of iodine supplementation in lactating mothers residing in countries with sustained salt iodization programs for iodine sufficiency of breast-fed infants remains unclear. The aims of this study were to investigate the effect of iodine supplementation on iodine status and growth parameters of lactating mothers and breast-fed infants and to compare these data with that of formula-feeding mothers and their infants during the first year of infancy.
Methods: In this multicenter, double-blinded, randomized clinical trial conducted in four healthcare centers in Tehran (Iran), healthy lactating mothers and their term newborns aged 3-5 days were randomly assigned to treatment groups: placebo, 150 μg/day iodine, or 300 μg/day iodine. They were followed up for 12 months. Formula-fed infants aged 30-45 days and their mothers were randomly selected from the same centers. The primary outcomes were maternal and infant urinary iodine concentrations (UICs), breast-milk iodine concentrations (BMICs), and infant growth parameters, measured at 1, 2, 4, 6, 9, and 12 months during routine health visits. The formula-fed group was assessed at 2, 4, 6, 9, and 12 months of age. Analysis was by per protocol principle using mixed-effects models.
Results: Mother-newborn pairs (n = 180) in treatment groups and partially/exclusively formula-feeding mother-infant pairs (n = 60) participated between October 2014 and January 2016. Median baseline UICs in the treatment groups were 84 μg/L (interquartile range [IQR] 41-143 μg/L) in mothers and 208 μg/L (IQR 91-310 μg/L) in their infants. The values in the formula-fed group were 76 μg/L (IQR 40-144 μg/L) in mothers and 121 μg/L (IQR 66-243 μg/L) in infants. The 300 μg/day iodine group showed significantly higher UICs and BMICs than did the other treatment groups; infant UICs in the 150 μg/day iodine, placebo, and formula-fed groups were similar. Infants in all groups showed iodine sufficiency (median UIC ≥100 μg/L) throughout the study period. Anthropometric measurements were similar between the treatment and formula-fed groups over the study period, except at the last follow-up visit at 12 months.
Conclusion: Supplementation of breast-feeding mothers with either 300 or 150 μg/day iodine improved their iodine status. However, the iodine status of infants in all groups studied indicated iodine sufficiency during the first year of infancy, demonstrating that in countries with effective salt iodization program, iodine supplementation for lactating mothers is unnecessary.
Keywords: breast-fed infants; formula-fed infants; iodine deficiency disorder; lactating mothers; salt iodization program.