Ready-to-use therapeutic food with elevated n-3 polyunsaturated fatty acid content, with or without fish oil, to treat severe acute malnutrition: a randomized controlled trial

Abstract Background Given the high risk of infectious mortality among children with severe acute malnutrition (SAM), the World Health Organization recommends routine administration of a broad-spectrum antibiotic like amoxicillin as part of the management of uncomplicated SAM. However, evidence for the efficacy of amoxicillin to improve nutritional recovery or reduce mortality has been mixed. With a long half-life and evidence of efficacy to reduce mortality in high-risk populations, azithromycin is a potential alternative to amoxicillin in the management of SAM. In this pilot study, we aim to compare the efficacy of azithromycin to amoxicillin to improve nutritional outcomes in children with uncomplicated SAM. Methods This pilot randomized controlled trial will enroll 300 children with uncomplicated SAM from 6 Centre de Santé et de Promotion Sociale in the Boromo health district in Burkina Faso. Eligible children are randomized to receive a single directly observed dose of oral azithromycin or a 7-day course of oral amoxicillin in addition to the standard package of care for uncomplicated SAM. Enrolled children are followed weekly until nutritional recovery, and all children return for a final study visit at 8 weeks after enrollment. Anthropometric indicators, vital status, and clinical outcomes are monitored at each visit and compared by arm. Primary feasibility outcomes include enrollment potential, refusals, loss to follow-up, and completeness of data collection. The primary clinical outcome is weight gain (g/kg/day) over the 8-week study period. Discussion This pilot trial will establish the feasibility of conducting a full-scale randomized controlled trial to evaluate alternative antibiotics in this setting and provide preliminary evidence for the efficacy of azithromycin compared to amoxicillin to improve outcomes for children with SAM. Trial registration This trial was first registered on clinicaltrials.gov on 26 June 2018 (NCT03568643).

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Randomized controlled trial evaluating probiotics in children with severe acute malnutrition

Indian Pediatrics ◽

10.1007/s13312-017-1053-y ◽

2017 ◽

Vol 54 (6) ◽

pp. 489-493

Author(s):

Joseph L. Mathew ◽

Praveen Kumar ◽

Rohan Malik

Keyword(s):

Randomized Controlled Trial ◽

Severe Acute Malnutrition ◽

Controlled Trial ◽

Acute Malnutrition ◽

Randomized Controlled

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Effectiveness of a Locally Produced, Fish-Based Food Product on Weight Gain among Cambodian Children in the Treatment of Acute Malnutrition: A Randomized Controlled Trial

Nutrients ◽

10.3390/nu10070909 ◽

2018 ◽

Vol 10 (7) ◽

pp. 909 ◽

Cited By ~ 8

Author(s):

Sanne Sigh ◽

Nanna Roos ◽

Chhoun Chamnan ◽

Arnaud Laillou ◽

Sophanneary Prak ◽

...

Keyword(s):

Randomized Controlled Trial ◽

Weight Gain ◽

Controlled Trial ◽

Food Product ◽

Acute Malnutrition ◽

Nutrition Interventions ◽

Randomized Controlled ◽

High Prevalence ◽

Lower Weight Gain ◽

Therapeutic Food

Cambodia continues to have a high prevalence of acute malnutrition. Low acceptability has been found for standard ready-to-use-therapeutic-food (RUTF) products. Therefore, NumTrey, a locally-produced fish-based RUTF, was developed. The objective was to evaluate the effectiveness of NumTrey compared to an imported milk-based RUTF for weight gain among children aged 6–59 months in the home-treatment for acute malnutrition. Effectiveness was tested in a single-blinded randomized controlled trial with weight gain as the primary outcome. Anthropometry was assessed at baseline and bi-weekly follow-ups until endline at Week 8. In total, 121 patients were randomized into BP-100TM (n = 61) or NumTrey (n = 60). There was no statistical difference in mean weight gain between the groups (1.06 g/kg/day; 95% CI (0.72, 1.41) and 1.08 g/kg/day; 95% CI (0.75, 1.41) for BP-100™ and NumTrey, respectively). In addition, no statistically significant differences in secondary outcomes were found. Although the ability to draw conclusions was limited by lower weight gain than the desired 4 g/kg/day in both groups, no superiority was found for eitherRUTF. A locally produced RUTF is highly relevant to improve nutrition interventions in Cambodia. A locally produced fish-based RUTF is a relevant alternative to imported milk-based RUTF for the treatment of SAM in Cambodia.

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