Dataset Information

In-home fortification with 2.5 mg iron as NaFeEDTA does not reduce anaemia but increases weight gain: a randomised controlled trial in Kenyan infants.

ABSTRACT: In-home fortification of infants with micronutrient powders (MNPs) containing 12.5 mg iron may increase morbidity from infections; therefore, an efficacious low-dose iron-containing MNP might be advantageous. Effects of iron-containing MNPs on infant growth are unclear. We assessed the efficacy of a low-iron MNP on iron status and growth and monitored safety in a randomised, controlled, double-blind 1-year trial in 6-month-old infants (n = 287) consuming daily a maize porridge fortified with either a MNP including 2.5 mg iron as NaFeEDTA (MNP + Fe) or the same MNP without iron (MNP - Fe). At baseline, after 6 and 12 months, we determined haemoglobin (Hb), iron status [serum ferritin (SF), soluble transferrin receptor (sTfR) and zinc protoporphyrin (ZPP)], inflammation [C-reactive protein (CRP)] and anthropometrics. We investigated safety using weekly morbidity questionnaires asking for diarrhoea, cough, flu, bloody or mucus-containing stool and dyspnoea, and recorded any other illness. Furthermore, feeding history and compliance were assessed weekly. At baseline, 71% of the infants were anaemic and 22% iron deficient; prevalence of inflammation was high (31% had an elevated CRP). Over the 1 year, Hb increased and SF decreased in both groups, without significant treatment effects of the iron fortification. At end point, the weight of infants consuming MNP + Fe was greater than in the MNP - Fe group (9.9 vs. 9.5 kg, P = 0.038). Mothers of infants in the MNP + Fe group reported more infant days spent with cough (P = 0.003) and dyspnoea (P = 0.0002); there were no significant differences on any other of the weekly morbidity measures. In this study, low-dose iron-containing MNP did not improve infant's iron status or reduce anaemia prevalence, likely because absorption was inadequate due to the high prevalence of infections and the low-iron dose.

SUBMITTER: Barth-Jaeggi T

PROVIDER: S-EPMC6860217 | biostudies-literature | 2015 Dec

REPOSITORIES: biostudies-literature

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In-home fortification with 2.5 mg iron as NaFeEDTA does not reduce anaemia but increases weight gain: a randomised controlled trial in Kenyan infants.

Barth-Jaeggi Tanja T Moretti Diego D Kvalsvig Jane J Holding Penny A PA Njenga Jane J Mwangi Alice A Chhagan Meera K MK Lacroix Christophe C Zimmermann Michael B MB

Maternal & child nutrition 20151201

In-home fortification of infants with micronutrient powders (MNPs) containing 12.5 mg iron may increase morbidity from infections; therefore, an efficacious low-dose iron-containing MNP might be advantageous. Effects of iron-containing MNPs on infant growth are unclear. We assessed the efficacy of a low-iron MNP on iron status and growth and monitored safety in a randomised, controlled, double-blind 1-year trial in 6-month-old infants (n = 287) consuming daily a maize porridge fortified with eit ...[more]

PMID: 25420455

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Project description:BackgroundWe aimed to show the non-inferiority of home fortification with a daily dose of 3 mg iron in the form of iron as ferric sodium ethylenediaminetetraacetate (NaFeEDTA) compared with 12.5 mg iron as encapsulated ferrous fumarate in Kenyan children aged 12-36 months. In addition, we updated a recent meta-analysis to assess the efficacy of home fortification with iron-containing powders, with a view to examining diversity in trial results.MethodsWe gave chemoprevention by dihydroartemisinin-piperaquine, albendazole and praziquantel to 338 afebrile children with haemoglobin concentration ≥70 g/L. We randomly allocated them to daily home fortification for 30 days with either placebo, 3 mg iron as NaFeEDTA or 12.5 mg iron as encapsulated ferrous fumarate. We assessed haemoglobin concentration (primary outcome), plasma iron markers, plasma inflammation markers and Plasmodium infection in samples collected at baseline and after 30 days of intervention. We conducted a meta-analysis of randomised controlled trials in pre-school children to assess the effect of home fortification with iron-containing powders on anaemia and haemoglobin concentration at end of intervention.ResultsA total of 315 children completed the 30-day intervention period. At baseline, 66.9% of children had inflammation (plasma C-reactive protein concentration >5 mg/L or plasma α 1-acid glycoprotein concentration >1.0 g/L); in those without inflammation, 42.5% were iron deficient. There was no evidence, either in per protocol analysis or intention-to-treat analysis, that home fortification with either of the iron interventions improved haemoglobin concentration, plasma ferritin concentration, plasma transferrin receptor concentration or erythrocyte zinc protoporphyrin-haem ratio. We also found no evidence of effect modification by iron status, anaemia status and inflammation status at baseline. In the meta-analysis, the effect on haemoglobin concentration was highly heterogeneous between trials (I 2: 84.1%; p value for test of heterogeneity: <0.0001).ConclusionsIn this population, home fortification with either 3 mg iron as NaFeEDTA or 12.5 mg iron as encapsulated ferrous fumarate was insufficiently efficacious to assess non-inferiority of 3 mg iron as NaFeEDTA compared to 12.5 mg iron as encapsulated ferrous fumarate. Our finding of heterogeneity between trial results should stimulate subgroup analysis or meta-regression to identify population-specific factors that determine efficacy.Trial registrationThe trial was registered with ClinicalTrials.gov ( NCT02073149 ) on 25 February 2014.

Project description:BackgroundThe efficacy of home fortification with iron-containing micronutrient powders varies between trials, perhaps in part due to population differences in adherence. We aimed to assess to what extent adherence measured by sachet count or self-reporting forms is in agreement with adherence measured by electronic device. In addition, we explored how each method of adherence assessment (electronic device, sachet count, self-reporting forms) is associated with haemoglobin concentration measured at the end of intervention; and to what extent baseline factors were associated with adherence as measured by electronic device.MethodsThree hundred thirty-eight rural Kenyan children aged 12-36 months were randomly allocated to three treatment arms (home fortification with two different iron formulations or placebo). Home fortificants were administered daily by parents or guardians over a 30 day-intervention period. We assessed adherence using an electronic device that stores and provides information of the time and day of opening of the container that was used to store the fortificants sachets in each child's residence. In addition, we assessed adherence by self-reporting and sachet counts. We also measured haemoglobin concentration at the end of intervention.ResultsAdherence, defined as having received at least 24 sachets (≥ 80%), during the 30-day intervention period was attained by only 60.6% of children as assessed by the electronic device. The corresponding values were higher when adherence was assessed by self-report (83.9%; difference: 23.3%, 95% CI: 18.8% to 27.8%) or sachet count (86.3%; difference: 25.7%, 95% CI: 21.0% to 30.4%). Among children who received iron, each 10 openings of the electronic cap of the sachet storage container were associated with an increase in haemoglobin concentration at the end of intervention by 1.2 g/L (95% CI: 0.0 to 1.9 g/L). Adherence was associated with the age of the parent but not with intervention group; with age, sex or anthropometric indices of the child; or with age or sex of the parent or guardian.ConclusionsThe use of self -reporting and sachet count may lead to overestimates of adherence to home fortification.Trial registrationThe trial was registered with ClinicalTrials.gov ( NCT02073149 ) on 25 February 2014.

Project description:BackgroundThe micronutrient home fortification programs contribute to the prevention of childhood anemia. WHO suggested applying culturally appropriate strategies to implement the micronutrient home fortification programs in various communities. However, there is little knowledge on evidence-based effective diffusion strategies of the micronutrient home fortification programs in multi-ethnic populations. This study aims to examine the diffusion of a micronutrient home fortification program with micronutrient powder (MNP) in a multi-ethnic population by investigating factors associated with being an 'early' or a 'later' adopter of MNP.MethodsWe conducted a cross-sectional study in rural western China. Multistage sampling was used to select children's caregivers in Han, Tibetan, and Yi ethnic communities (N = 570). The diffusion of innovations theory informed the data collection on caregivers' decision process and was applied to classify participants into the MNP adopter categories of 'leaders', 'followers', 'loungers', and 'laggards'. The ordered logistic regression model estimated the factors associated with the MNP adopter categories.ResultsCaregivers from the Yi ethnic subgroup were likely to adopt MNP relatively late (AOR = 1.67; 95%CI = 1.09, 2.54) compared with Han and Tibetan ethnic subgroups. Caregivers with more knowledge regarding the MNP feeding method (AOR = 0.71; 95%CI = 0.52, 0.97) and those with stronger self-efficacy in adopting MNP (AOR = 0.85; 95%CI = 0.76, 0.96) were more likely to adopt MNP earlier than others. The following messages and channels also tend to make caregivers adopt MNP earlier: hearing that 'MNP was free' from villagers (AOR = 0.45; 95%CI = 0.20, 0.98), and learning 'MNP feeding method' from township doctors (AOR = 0.16; 95%CI = 0.06, 0.48).ConclusionsDisparities in adopting MNP existing among different ethnic groups require more effective diffusion strategies in disadvantaged minority ethnic groups. Enhancing self-efficacy in adopting MNP and knowledge on feeding method of MNP have the potential to make caregivers adopt MNP earlier. Peer networks and township doctors can be effective agencies to facilitate the diffusion and adoption of MNP.

Project description:BackgroundThe WHO recommends daily use of micronutrient powder for infants and toddlers at risk of micronutrient deficiencies in low-and-middle-income countries. China has established a micronutrient powder distribution program in many rural townships and villages, yet adherence to micronutrient powder remains suboptimal; a little is known about the behavioral inputs that may influence adherence. This study examines direct and indirect behavioral inputs in micronutrient powder adherence among caregivers in rural western China following the Integrated Behavioral Model (IBM) framework.MethodsCross-sectional data were collected from April to May 2019 among 958 caregivers of children aged 6 to 24 months in six counties. Data were collected on micronutrient powder adherence behavior, direct behavioral inputs (knowledge and skills, intention, salience, environmental constraints, and habits), and indirect behavioral inputs (attitudes, perceived social norms, and personal agency). Structural equation modeling (SEM) adjusted for sociodemographic covariates was used to evaluate the IBM framework.ResultsMean micronutrient powder adherence in the previous seven days was 53.02%, and only 22.86% of caregivers consistently fed micronutrient powder from the start of micronutrient powder distribution at six months of age. The SEM model revealed small- to medium-sized effects of salience (β = 0.440, P < 0.001), intention (β = 0.374, P < 0.001), knowledge and skills (β = 0.214, P < 0.001), personal agency (st. effect = 0.172, P < 0.001), environmental constraints (β=-0.142, P < 0.001), and caregiver generation (β = 0.119, P < 0.05) on micronutrient powder adherence. Overall, 54.7% of the variance in micronutrient powder adherence was explained by the IBM framework. Salience had the largest impact on micronutrient powder adherence (Cohen's f 2 = 0.227). Compared to parent caregivers, grandparents had a higher degree of micronutrient powder adherence on average (P < 0.001), and behavioral inputs were consistent among both parent and grandparent caregivers.ConclusionThere is a need to improve micronutrient powder adherence among rural caregivers. The IBM framework showed a high degree of explanatory power in predicting micronutrient powder adherence behavior. The findings suggest that increased reminders from doctors regarding micronutrient powder and coaching to improve personal agency in micronutrient powder feeding may increase adherence.

Project description:CONTEXT:Pneumonia is the leading cause of childhood death in sub-Saharan Africa. Comparative estimates of the contribution of causative pathogens to the burden of disease are essential for targeted vaccine development. OBJECTIVE:To determine the viral etiology of severe pneumonia among infants and children at a rural Kenyan hospital using comprehensive and sensitive molecular diagnostic techniques. DESIGN, SETTING, AND PARTICIPANTS:Prospective observational and case-control study during 2007 in a rural Kenyan district hospital. Participants were children aged 1 day to 12 years, residing in a systematically enumerated catchment area, and who either were admitted to Kilifi District Hospital meeting World Health Organization clinical criteria for severe pneumonia or very severe pneumonia; (2) presented with mild upper respiratory tract infection but were not admitted; or (3) were well infants and children attending for immunization. MAIN OUTCOME MEASURES:The presence of respiratory viruses and the odds ratio for admission with severe disease. RESULTS:Of 922 eligible admitted patients, 759 were sampled (82% [median age, 9 months]). One or more respiratory viruses were detected in 425 of the 759 sampled (56% [95% confidence interval {CI}, 52%-60%]). Respiratory syncytial virus (RSV) was detected in 260 participants (34% [95% CI, 31%-38%]) and other respiratory viruses were detected in 219 participants (29%; 95% CI, 26%-32%), the most common being Human coronavirus 229E (n = 51 [6.7%]), influenza type A (n = 44 [5.8%]), Parainfluenza type 3 (n = 29 [3.8%]), Human adenovirus (n = 29 [3.8%]), and Human metapneumovirus (n = 23 [3.0%]). Compared with well control participants, detection of RSV was associated with severe disease (5% [corrected] in control participants; adjusted odds ratio, 6.11 [95% CI, 1.65-22.6]) while collectively, other respiratory viruses were not associated with severe disease (23% in control participants; adjusted odds ratio, 1.27 [95% CI, 0.64-2.52]). CONCLUSION:In a sample of Kenyan infants and children admitted with severe pneumonia to a rural hospital, RSV was the predominant viral pathogen.

Dataset Information

In-home fortification with 2.5 mg iron as NaFeEDTA does not reduce anaemia but increases weight gain: a randomised controlled trial in Kenyan infants.

Publications

In-home fortification with 2.5 mg iron as NaFeEDTA does not reduce anaemia but increases weight gain: a randomised controlled trial in Kenyan infants.

Similar Datasets

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