Abstract
Micronutrient Powder (MNP) is beneficial to control anemia, but some iron-related side-effects are common. A high level of iron in the groundwater used for drinking may exacerbate the side-effects among MNP users. We conducted a randomized controlled trial examining the effect of a low-dose iron MNP compared with the standard MNP in children aged 2–5 years residing in a high-groundwater-iron area in rural Bangladesh. We randomized 327 children, who were drinking from the “high-iron” wells (≥2 mg/L), to receive either standard (12.5 mg iron) or low-dose iron (5.0 mg iron) MNP, one sachet per day for two months. Iron parameters were measured both at baseline and end-point. The children were monitored weekly for morbidities. A generalized linear model was used to determine the treatment effect of the low-dose iron MNP. Poisson regressions were used to determine the incidence rate ratios of the morbidities. The trial was registered at ISRCTN60058115. Changes in the prevalence of anemia (defined as a hemoglobin level < 11.0 g/dL) were 5.4% (baseline) to 1.0% (end-point) in the standard MNP; and 5.8% (baseline) to 2.5% (end-point) in the low-dose iron MNP groups. The low-dose iron MNP was non-inferior to the standard MNP on hemoglobin outcome (β = −0.14, 95% CI: −0.30, 0.013; p = 0.07). It resulted in a lower incidence of diarrhea (IRR = 0.29, p = 0.01, 95% CI: 0.11–0.77), nausea (IRR = 0.24, p = 0.002, 95% CI: 0.09–0.59) and fever (IRR = 0.26, p < 0.001, 95% CI: 0.15–0.43) compared to the standard MNP. Low-dose iron MNP was non-inferior to the standard MNP in preventing anemia yet demonstrated an added advantage of lowering the key side-effects.
Highlights
Anemia is a major public health problem in the low- and middle-income countries [1]
It resulted in a lower incidence of diarrhea (IRR = 0.29, p = 0.01, 95% CI: 0.11–0.77), nausea (IRR = 0.24, p = 0.002, 95% CI: 0.09–0.59) and fever (IRR = 0.26, p < 0.001, 95% CI: 0.15–0.43) compared to the standard Micronutrient Powder (MNP)
To determine the non-inferiority margin, we considered an earlier trial examining the efficacy of the standard MNP on hemoglobin status in rural anemic children of Bangladesh, which demonstrated an increase in hemoglobin level by 1.61 g/dL following an 8-week-long intervention [38]
Summary
Anemia is a major public health problem in the low- and middle-income countries [1]. Anemia in children, defined as a hemoglobin level < 11.0 g/dL, is associated with impaired cognitive performance; increased mortality and morbidity; and poorer educational attainment in children [2]. The World Health Organization recommends Micronutrient Powder (MNP), a powdered formulation consisting of key micronutrients, including iron, as an intervention to prevent childhood anemia [4]. In the presence of a sufficient reserve of body iron or systemic inflammation, the intestinal uptake of iron may be limited due to hepcidin-mediated regulation [9,10]. The unabsorbed iron in the gut might affect the composition of the gut microbiome, leading to the side effects [11,12]. In this context, trials have been conducted assessing the efficacy of low-iron MNPs in African settings with a high infection burden
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