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Micronutrient powders for young children
Correspondence
Sajid Soofi and colleagues recently reported (July 6, p 29)1 that Pakistani children aged 6–18 months, who used micronutrient powders containing five micronutrients with or without zinc, had small increases in caregiverreported diarrhoea and chest indrawing. The investigators concluded that caution should be exercised until further safety studies of micronutrient powders are done. We believe these conclusions are far stronger than warranted by the results and raise four questions when interpreting these findings. First, what is the quality of evidence? This study1 was the largest clinical trial of micronutrient powders to date, following nearly 2000 children and measuring growth, micronutrient status, and morbidity. However, the trial had important design limitations, including the use of maternal recall of morbidity, and no placebo in the control group. Mothers in the micronutrient powders group might have over-reported morbidity because of changes in stool consistency known to occur with iron supplementation,2 or because of concerns about providing an unknown product to their children. Despite delivering a daily supply of micronutrient powders to households every 2 weeks, utilisation was only 50%, which could represent poor behaviour change; dose-response analyses would be helpful in validating the results. Second, are the findings generalisable? With 25% wasting and nearly five episodes of diarrhoea per year at baseline, interventions— including management of acute malnutrition and common childhood infections—are clearly needed in this population. Micronutrient powders do not contain protein or energy, and were never designed to be standalone interventions for malnourished children. Current programmatic guidance for micronutrient powders recommends implementation as part www.thelancet.com Vol 382 October 5, 2013
of infant and young child feeding interventions, which was not done in this study. Although smaller, other studies have shown reductions or no difference in diarrhoea and respiratory illness among children using micronutrient powders compared with placebo.3,4 Third, what mechanisms could explain the results obtained by Soofi and colleagues? 1 The increase in diarrhoea might reflect adaptation of gut microflora to increased iron intake. However, there was no increase in specific stool pathogens likely induced by iron, and no effect on severe diarrhoea or hospitalisation with diarrhoea.1 Reported side-effects of micronutrient powders are mild, consisting mainly of diarrhoea and darkening of stools in 10–15% of users.2 The increased rates of chest indrawing could be related to vitamin A restoring respiratory epithelium. The lack of improvements in diarrhoea and respiratory morbidity might partially be explained by failure to improve vitamin A or zinc status. Finally, there is a need to carefully weigh benefits and risks. Soofi and colleagues’ study 1 confirms the beneficial effect of micronutrient powders on iron deficiency anaemia and demonstrates significant, albeit small, improvements in linear growth. 1 Although there was a difference in diarrhoea and respiratory illness between the trial groups, the clinical significance of this difference is questionable. Micronutrient powder programmes have been implemented to scale in more than 40 countries globally and have been shown in programme evaluations to reduce iron deficiency anaemia. Distribution of micronutrient powders should be integrated with other health interventions and should adopt a standardised approach for monitoring and evaluation. More research is needed on the safety of iron interventions and micronutrient powder programmes;5 however, the findings from this single study1 should
not halt this effective global public health intervention. PSS receives salary support from the Centers for Disease Control and Prevention, and LMN is a member of the Home Fortification Technical Advisory Group.
Ton Koene/dpa/Corbis
Micronutrient powders for young children
*Parminder S Suchdev, Lynnette M Neufeld [email protected] Department of Pediatrics and Hubert Department of Global Health, Emory University, Atlanta, GA 30322, USA (PSS); and Micronutrient Initiative, Ottawa, ON, Canada (LMN) 1
2
3
4
5
Soofi S, Cousens S, Iqbal SP, et al. Effect of provision of daily zinc and iron with several micronutrients on growth and morbidity among young children in Pakistan: a clusterrandomised trial. Lancet 2013; 382: 29–40. Zlotkin S, Arthur P, Antwi KY, Yeung G. Treatment of anemia with microencapsulated ferrous fumarate plus ascorbic acid supplied as sprinkles to complementary (weaning) foods. Am J Clin Nutr 2001; 74: 791–95. Sharieff W, Bhutta Z, Schauer C, Tomlinson G, Zlotkin S. Micronutrients (including zinc) reduce diarrhoea in children: the Pakistan Sprinkles Diarrhoea Study. Arch Dis Child 2006; 91: 573–79. Lemaire M, Islam QS, Shen H, et al. Iron-containing micronutrient powder provided to children with moderate-to-severe malnutrition increases hemoglobin concentrations but not the risk of infectious morbidity: a randomized, double-blind, placebo-controlled, noninferiority safety trial. Am J Clin Nutr 2011; 94: 585–93. Prentice AM, Verhoef H, Cerami C. Iron fortification and malaria risk in children. JAMA 2013; 310: 914–15.
A cluster-randomised trial1 implemented in Pakistan provided crucial information for the use of multiple micronutrients in malnourished children. Sajid Soofi and colleagues1 reported excess morbidity compared with the small effect on growth from multiple micronutrients powders. They noted that an increase in diarrhoea might be attributable to iron supplementation as previously reported, but a question should be raised on the validity of the age-specific dose for the population. Moreover, as the duration of the intervention is long and the target age ranges from 6 to 18 months, we doubt whether it is appropriate to provide similar doses for young children at different ages. We agree that the assessment and monitoring of risks and benefits of current intervention strategies are
For the Programmatic Guidance Brief on use of micronutrient powders for home fortification see http://hftag.gainhealth.org/ resources/programmaticguidance-brief-usemicronutrient-powders-mnphome-fortification Submissions should be made via our electronic submission system at http://ees.elsevier.com/ thelancet/
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Sajid Soofi and colleagues recently reported (July 6, p 29)1 that Pakistani children aged 6–18 months, who used micronutrient powders containing five micronutrients with or without zinc, had small increases in caregiverreported diarrhoea and chest indrawing. The investigators concluded that caution should be exercised until further safety studies of micronutrient powders are done. We believe these conclusions are far stronger than warranted by the results and raise four questions when interpreting these findings. First, what is the quality of evidence? This study1 was the largest clinical trial of micronutrient powders to date, following nearly 2000 children and measuring growth, micronutrient status, and morbidity. However, the trial had important design limitations, including the use of maternal recall of morbidity, and no placebo in the control group. Mothers in the micronutrient powders group might have over-reported morbidity because of changes in stool consistency known to occur with iron supplementation,2 or because of concerns about providing an unknown product to their children. Despite delivering a daily supply of micronutrient powders to households every 2 weeks, utilisation was only 50%, which could represent poor behaviour change; dose-response analyses would be helpful in validating the results. Second, are the findings generalisable? With 25% wasting and nearly five episodes of diarrhoea per year at baseline, interventions— including management of acute malnutrition and common childhood infections—are clearly needed in this population. Micronutrient powders do not contain protein or energy, and were never designed to be standalone interventions for malnourished children. Current programmatic guidance for micronutrient powders recommends implementation as part www.thelancet.com Vol 382 October 5, 2013
of infant and young child feeding interventions, which was not done in this study. Although smaller, other studies have shown reductions or no difference in diarrhoea and respiratory illness among children using micronutrient powders compared with placebo.3,4 Third, what mechanisms could explain the results obtained by Soofi and colleagues? 1 The increase in diarrhoea might reflect adaptation of gut microflora to increased iron intake. However, there was no increase in specific stool pathogens likely induced by iron, and no effect on severe diarrhoea or hospitalisation with diarrhoea.1 Reported side-effects of micronutrient powders are mild, consisting mainly of diarrhoea and darkening of stools in 10–15% of users.2 The increased rates of chest indrawing could be related to vitamin A restoring respiratory epithelium. The lack of improvements in diarrhoea and respiratory morbidity might partially be explained by failure to improve vitamin A or zinc status. Finally, there is a need to carefully weigh benefits and risks. Soofi and colleagues’ study 1 confirms the beneficial effect of micronutrient powders on iron deficiency anaemia and demonstrates significant, albeit small, improvements in linear growth. 1 Although there was a difference in diarrhoea and respiratory illness between the trial groups, the clinical significance of this difference is questionable. Micronutrient powder programmes have been implemented to scale in more than 40 countries globally and have been shown in programme evaluations to reduce iron deficiency anaemia. Distribution of micronutrient powders should be integrated with other health interventions and should adopt a standardised approach for monitoring and evaluation. More research is needed on the safety of iron interventions and micronutrient powder programmes;5 however, the findings from this single study1 should
not halt this effective global public health intervention. PSS receives salary support from the Centers for Disease Control and Prevention, and LMN is a member of the Home Fortification Technical Advisory Group.
Ton Koene/dpa/Corbis
Micronutrient powders for young children
*Parminder S Suchdev, Lynnette M Neufeld [email protected] Department of Pediatrics and Hubert Department of Global Health, Emory University, Atlanta, GA 30322, USA (PSS); and Micronutrient Initiative, Ottawa, ON, Canada (LMN) 1
2
3
4
5
Soofi S, Cousens S, Iqbal SP, et al. Effect of provision of daily zinc and iron with several micronutrients on growth and morbidity among young children in Pakistan: a clusterrandomised trial. Lancet 2013; 382: 29–40. Zlotkin S, Arthur P, Antwi KY, Yeung G. Treatment of anemia with microencapsulated ferrous fumarate plus ascorbic acid supplied as sprinkles to complementary (weaning) foods. Am J Clin Nutr 2001; 74: 791–95. Sharieff W, Bhutta Z, Schauer C, Tomlinson G, Zlotkin S. Micronutrients (including zinc) reduce diarrhoea in children: the Pakistan Sprinkles Diarrhoea Study. Arch Dis Child 2006; 91: 573–79. Lemaire M, Islam QS, Shen H, et al. Iron-containing micronutrient powder provided to children with moderate-to-severe malnutrition increases hemoglobin concentrations but not the risk of infectious morbidity: a randomized, double-blind, placebo-controlled, noninferiority safety trial. Am J Clin Nutr 2011; 94: 585–93. Prentice AM, Verhoef H, Cerami C. Iron fortification and malaria risk in children. JAMA 2013; 310: 914–15.
A cluster-randomised trial1 implemented in Pakistan provided crucial information for the use of multiple micronutrients in malnourished children. Sajid Soofi and colleagues1 reported excess morbidity compared with the small effect on growth from multiple micronutrients powders. They noted that an increase in diarrhoea might be attributable to iron supplementation as previously reported, but a question should be raised on the validity of the age-specific dose for the population. Moreover, as the duration of the intervention is long and the target age ranges from 6 to 18 months, we doubt whether it is appropriate to provide similar doses for young children at different ages. We agree that the assessment and monitoring of risks and benefits of current intervention strategies are
For the Programmatic Guidance Brief on use of micronutrient powders for home fortification see http://hftag.gainhealth.org/ resources/programmaticguidance-brief-usemicronutrient-powders-mnphome-fortification Submissions should be made via our electronic submission system at http://ees.elsevier.com/ thelancet/
1171