Impact of food supplements on hemoglobin, iron status, and inflammation in children with moderate acute malnutrition: a 2 × 2 × 3 factorial randomized trial in Burkina Faso

Abstract Child acute malnutrition (AM) is an important cause of child mortality. Accurately estimating its burden requires cumulative incidence data from longitudinal studies, which are rarely available in low-income settings. In the absence of such data, the AM burden is approximated using prevalence estimates from cross-sectional surveys and the incidence correction factor $K$, obtained from the few available cohorts that measured AM. We estimated $K$ factors for severe acute malnutrition (SAM) and moderate acute malnutrition (MAM) from AM incidence and prevalence using representative cross-sectional baseline and longitudinal data from 2 cluster-randomized controlled trials (Innovative Approaches for the Prevention of Childhood Malnutrition—PROMIS) conducted between 2014 and 2017 in Burkina Faso and Mali. We compared K estimates using complete (weight-for-length z score, mid-upper arm circumference (MUAC), and edema) and partial (MUAC, edema) definitions of SAM and MAM. $K$ estimates for SAM were 9.4 and 5.7 in Burkina Faso and in Mali, respectively; K estimates for MAM were 4.7 in Burkina Faso and 5.1 in Mali. The MUAC and edema–based definition of AM did not lead to different $K$ estimates. Our results suggest that $K$ can be reliably estimated when only MUAC and edema-based data are available. Additional studies, however, are required to confirm this finding in different settings.

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Comparing azithromycin to amoxicillin in the management of uncomplicated severe acute malnutrition in Burkina Faso: a pilot randomized trial

10.1101/2021.06.15.21258967 ◽

2021 ◽

Author(s):

Kieran S O'Brien ◽

Ali Sié ◽

Clarisse Dah ◽

Millogo Ourohire ◽

Moussa Ouédraogo ◽

...

Keyword(s):

Single Dose ◽

Weight Gain ◽

Adverse Events ◽

Burkina Faso ◽

Randomized Trial ◽

Severe Acute Malnutrition ◽

Acute Malnutrition ◽

World Health ◽

Promising Alternative

Introduction. Given the potential for asymptomatic infection in children with uncomplicated severe acute malnutrition (SAM), the World Health Organization recommends a broad-spectrum antibiotic like amoxicillin. Azithromycin is a promising alternative to amoxicillin as it can be administered as a single dose and has efficacy against several pathogens involved in the burden of infectious disease and mortality in this population. In this pilot study, we aimed to establish the feasibility of a larger randomized controlled trial and to provide preliminary evidence comparing the effect of azithromycin to amoxicillin on weight gain in children with uncomplicated SAM. Methods. This pilot randomized trial enrolled children 6-59 months old with uncomplicated SAM at 6 healthcare centers in Burkina Faso. Participants were randomized to a single dose of azithromycin or a 7-day course of amoxicillin. All participants received ready-to-use therapeutic food and were followed weekly until nutritional recovery and again at 8 weeks. The primary feasibility outcomes included enrollment potential, refusals, and loss to follow-up. The primary clinical outcome was weight gain (g/kg/day) over the 8-week period. Outcome assessors were masked. Results. Between June and October 2020, 312 children were screened, 301 were enrolled with 0 refusals, and 282 (93.6%) completed the 8-week visit. Average weight gain was 2.5 g/kg/day (SD 2.0) in the azithromycin group and 2.6 (SD) 1.7) in the amoxicillin group (Mean Difference -0.1, 95% CI -0.5 to 0.3, P = 0.63). Fewer adverse events were reported in the azithromycin group (Risk Ratio 0.50, 95% CI 0.31 to 0.82, P = 0.006). Conclusions. No differences were found in weight gain between groups. Given the ability to administer a single dose and the potential for fewer adverse events, azithromycin may be an alternative to amoxicillin for uncomplicated SAM. With strong enrollment and follow-up, a larger trial in this setting is feasible.

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