Short Malnourished Children and Fat Accumulation With Food Supplementation.

BACKGROUND: In moderate acute malnutrition programs, it is common practice to not measure mid-upper arm circumference (MUAC) of children whose length is .5). CONCLUSIONS: Short children with low MUAC do not gain excessive fat during supplementation. With these data, we support a recommendation for policy change to include all children ≥6 months with low MUAC in supplementary feeding programs, regardless of length. The use of length as a criterion for measuring MUAC to determine treatment eligibility should be discontinued in policy and practice

Effectiveness of food supplements in increasing fat-free tissue accretion in children with moderate acute malnutrition: A randomised 2 × 2 × 3 factorial trial in Burkina Faso.

BACKGROUND: Children with moderate acute malnutrition (MAM) are treated with lipid-based nutrient supplement (LNS) or corn-soy blend (CSB). We assessed the effectiveness of (a) matrix, i.e., LNS or CSB, (b) soy quality, i.e., soy isolate (SI) or dehulled soy (DS), and (c) percentage of total protein from dry skimmed milk, i.e., 0%, 20%, or 50%, in increasing fat-free tissue accretion. METHODS AND FINDINGS: Between September 9, 2013, and August 29, 2014, a randomised 2 × 2 × 3 factorial trial recruited 6- to 23-month-old children with MAM in Burkina Faso. The intervention comprised 12 weeks of food supplementation providing 500 kcal/day as LNS or CSB, each containing SI or DS, and 0%, 20%, or 50% of protein from milk. Fat-free mass (FFM) was assessed by deuterium dilution technique. By dividing FFM by length squared, the primary outcome was expressed independent of length as FFM index (FFMI) accretion over 12 weeks. Other outcomes comprised recovery rate and additional anthropometric measures. Of 1,609 children, 4 died, 61 were lost to follow-up, and 119 were transferred out due to supplementation being switched to non-experimental products. No children developed allergic reaction. At inclusion, 95% were breastfed, mean (SD) weight was 6.91 kg (0.93), with 83.5% (5.5) FFM. In the whole cohort, weight increased 0.90 kg (95% CI 0.88, 0.93; p 0.05). LNS compared to CSB resulted in 128 g (95% CI 67, 190; p < 0.01) greater weight gain if both contained SI, but there was no difference between LNS and CSB if both contained DS (mean difference 22 g; 95% CI -40, 84; p = 0.49) (interaction p = 0.017). Accordingly, SI compared to DS increased weight by 89 g (95% CI 27, 150; p = 0.005) when combined with LNS, but not when combined with CSB. A limitation of this and other food supplementation trials is that it is not possible to collect reliable data on individual adherence. CONCLUSIONS: Based on this study, children with MAM mainly gain fat-free tissue when rehabilitated. Nevertheless, LNS yields more fat-free tissue and higher recovery rates than CSB. Moreover, current LNSs with DS may be improved by shifting to SI. The role of milk relative to soy merits further research. TRIAL REGISTRATION: ISRCTN registry ISRCTN42569496

Association between admission criteria and body composition among young children with moderate acute malnutrition, a cross-sectional study from Burkina Faso

AbstractChildren with moderate acute malnutrition (MAM) are treated based on low weight-for-length z-score (WLZ), low mid-upper arm circumference (MUAC) or both. This study aimed to assess associations of admission criteria and body composition (BC), to improve treatment of MAM. We undertook a cross-sectional study among 6–23 months old Burkinabe children with MAM. Fat-free (FFM) and fat mass (FM) were determined by deuterium dilution and expressed as FFM (FFMI) and FM index (FMI). Of 1,489 children, 439 (29.5%) were recruited by low MUAC only (MUAC-O), 734 (49.3%) by low WLZ and low MUAC (WLZ-MUAC) and 316 (21.2%) by low WLZ only (WLZ-O). Thus, 1,173 (78.8%) were recruited by low MUAC, with or without low WLZ (ALL-MUAC). After adjustments, WLZ-O had 89 g (95% confidence interval (CI) 5; 172) lower FFM compared to MUAC-O. Similarly, WLZ-O had 0.89 kg/m2 (95% CI 0.77; 1.01) lower FFMI compared to MUAC-O, whereas there was no difference for FMI. However, boys included by WLZ-O compared to MUAC-O had 0.21 kg/m2 (95% CI 0.05; 0.38) higher FMI. In contrast, girls included by WLZ-O had 0.17 (95% CI 0.01; 0.33) kg/m2 lower FMI compared to MUAC-O (interaction, p = 0.002). We found that different criteria for admission into MAM treatment programmes select children with differences in BC, especially FFMI.Trial registration: ISRCTN42569496.</jats:p

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.

Background: Children with moderate acute malnutrition (MAM) are treated with lipid-based nutrient supplements (LNSs) or corn-soy blends (CSBs) but little is known about the impact of these supplements on hemoglobin, iron status, and inflammation. Objective: The objective of this study was to investigate the impact of supplementary foods for treatment of MAM on hemoglobin, iron status, inflammation, and malaria. Design: A randomized 2 × 2 × 3 factorial trial was conducted in Burkina Faso. Children aged 6-23 mo with MAM received 500 kcal/d as LNS or CSB, containing either dehulled soy (DS) or soy isolate (SI) and different quantities of dry skimmed milk (0%, 20% or 50% of total protein) for 12 wk. The trial was double-blind with regard to quality of soy and quantity of milk, but not matrix (CSB compared to LNS). Hemoglobin, serum ferritin (SF), serum soluble transferrin receptor (sTfR), serum C-reactive protein (CRP), serum α1-acid glycoprotein (AGP), and malaria antigens were measured at inclusion and after supplementation. Results: Between September 2013 and August 2014, 1609 children were enrolled. Among these, 61 (3.8%) were lost to follow-up. During the 12-wk supplementation period, prevalence of anemia, low SF adjusted for inflammation (SFAI), elevated sTfR, and iron-deficiency anemia decreased by 16.9, 8.7, 12.6 and 10.5 percentage points. Children who received LNS compared to CSB had higher hemoglobin (2 g/L; 95% CI: 1, 4 g/L), SFAI (4.2 µg/L; 95% CI: 2.9, 5.5 µg/L), and CRP (0.8 mg/L; 95% CI: 0.4, 1.2 mg/L) and lower sTfR (-0.9 mg/L, 95% CI: -1.3, -0.6 mg/L) after the intervention. Replacing DS with SI or increasing milk content did not affect hemoglobin, SFAI, sTfR, or CRP. Conclusion: Supplementation with LNS compared to CSB led to better hemoglobin and iron status, but overall prevalence of anemia remained high. The higher concentrations of acute-phase proteins in children who received LNSs requires further investigation. This trial was registered at www.controlled-trials.com as ISRCTN42569496

Assessment of Micronutrients of Solanum aethiopicum and Solanum melongena Fruits Consumed in Burkina Faso

Aim: In Burkina Faso, low micronutrients intake is one of factors responsible of under five years children malnutrition. Research on local food to find best vegetables rich in micronutrients is a way to improve children nutrition. The aim of this study is to assess micronutrients content in the fruits of Solanum aethiopicum and Solanum melongena grown in Burkina Faso. Methodology: From three markets of Ouagadougou city, fresh samples of fruits of the two plants have been purchased. After one month drying in laboratory at 25°C, the dried samples were used to determine content of Calcium (Ca), Magnesium (Mg), Potassium (K), Sodium (Na), Phosphor (P), Iron (Fe) and Zinc (Zn) using flam photometer and atomic absorption spectrophotometer. Results: The results showed high content of K, Mg and Ca in the fruits. The content of Na, P is also satisfying. Fe and Zn known as trace elements are also well represented in the two fruits. The values were 3582, 187, 126, 87, 29, 21 and 2 mg/100 g for K, Mg, Ca, Na, P, Fe and Zn, respectively for the fruits of S. aethiopicum. S. melongena fruits had 2991, 317, 207, 135, 30, 6 and 4 mg/100 g for K, Ca, Mg, Na, P, Fe and Zn, respectively.  Conclusion: These two fruits are important sources of micronutrients and must be included in children diet to improve their nutritional status

C31 Utilisation du polyéthylène glycol 8000 comme plastifiant pour le développement de dispersions solides à base d’acide ellagique et d’Eudragit® EPO par extrusion à chaud

Introduction : L’acide ellagique (AE) est un composé polyphénolique, possédant des propriétés antipaludiques ainsi que d’autres activités thérapeutiques prometteuses. Cependant, ses propriétés physicochimiques défavorables (faible solubilité et faible perméabilité, BCS IV) limitent sa biodisponibilité par voie orale. Le but de notre étude était de produire par extrusion à chaud des dispersions solides ternaires à taux de charge élevé en substance active en vue d’une utilisation efficiente de l’acide ellagique en thérapeutique humaine. Matériel et méthodes : Des mélanges physiques ternaires composés d’EA/Eudragit® EPO/PEG 8000 dans des proportions de 15/75/10 (F1), 20/70/10 (F2), 25/65/10 (F3), 15/80/5 (F4) et 20/85/5 (F5) % m/m, respectivement ont été triturés au mortier puis extrudés à l’aide d’une extrudeuse co- rotative bi- vis pour l’obtention des dispersions solides ternaires. Les extrudats broyés et tamisés ont été caractérisés par diffraction aux rayons X, spectroscopie infrarouge à transformée de fourrier, spectroscopie à résonnance magnétique nucléaire et par des tests de dissolution dans des conditions non sink en milieu acide (HCl 0,1N,). Résultats et Discussion : Quatre des cinq formulations ont été extrudés avec succès. Il s’agissait des formulations F1, F2, F4 et F5. La formulation F3 n’a pu être extrudée car nécessitait un couple moteur supérieur à la force maximale développée par l’extrudeuse (40Nm). La diffraction aux rayons X a montré la présence de résidus cristallins dans toutes les dispersions solides ternaires, confirmée par la spectroscopie à résonnance magnétique nucléaire. La libération de l’AE à partir des dispersions ternaires était beaucoup plus importante avec les formulations F4 et F5 comparativement aux formulations F1 et F2. En effet, après 15 min de test, les taux de dissolution de l’AE étaient 88,75±3,02%, 83,47±4,40%, 62,67±3,10 et 58,74±7,23 % respectivement pour les formulations F4, F5, F2 et F1. Le profil de libération de l’AE à partir des formulations F1 et F2 présentait une tendance à la recristallisation de ce dernier dans le milieu de dissolution. Conclusion : Au regard de ses performances pharmaceutiques, de sa teneur en AE et en plastifiant, la formulation F5 apparaissait comme étant la plus appropriée pour une utilisation efficiente de l’AE en thérapeutique humaine

Deuterium dilution technique for body composition assessment: resolving methodological issues in children with moderate acute malnutrition

<p>Childhood malnutrition is highly prevalent and associated with high mortality risk. In observational and interventional studies among malnourished children, body composition is increasingly recognised as a key outcome. The deuterium dilution technique has generated high-quality data on body composition in studies of infants and young children in several settings, but its feasibility and accuracy in children suffering from moderate acute malnutrition requires further study. Prior to a large nutritional intervention trial among children with moderate acute malnutrition, we conducted pilot work to develop and adapt the deuterium dilution technique. We refined procedures for administration of isotope doses and collection of saliva. Furthermore, we established that equilibration time in local context is 3 h. These findings and the resulting standard operating procedures are important to improve data quality when using the deuterium dilution technique in malnutrition studies in field conditions, and may encourage a wider use of isotope techniques.</p

Quality and in vitro bioequivalence evaluation of different brands of amoxicillin + clavulanic acid (500 + 62.5) mg tablets distributed in Burkina Faso

In a previous study, we reported the evaluation of the physicochemical quality and in vitro bioequivalence of different brands of amoxicillin capsules 500 mg marketed in Burkina Faso. As our goal was to document the quality and biopharmaceutical performance of essential antibiotics marketed in resource-limited countries, we investigated here, the interchangeability with the originator of five brands of amoxicillin + clavulanic acid (500mg+62.5mg) tablets distributed in Burkina Faso. The physicochemical quality of the different brands was first verified according to the USP monograph. The comparative evaluation of the in vitro dissolution profiles was performed in three different pH environments (1.2 - 4.5 - 6.8) using statistical calculations of the difference (f1) and similarity (f2) factors. All brands of amoxicillin + clavulanic acid (500mg+62.5mg) tablets, including the originator, met USP specifications for weight uniformity, identification, content and dissolution of active ingredients. However, the similarity and difference factor values showed that two generic brands (B and E) did not have similar amoxicillin dissolution profiles to the comparator product in pH 4.5 media (f1 = 23,54 and 17.02; f2=35.96 and 46.90, respectively). Therefore, these two products cannot be used interchangeably with the originator. The other three generic brands were similar to the originator and can therefore probably be used interchangeably

Application of polyethylene glycol 8000 as plasticizer for the development of ellagic acid and Eudragit® EPO based solid dispersions using hot melt extrusion.

Solid dispersion formation by Hot melt extrusion (HME) is a widely used formulation strategy to improve the solubility and bioavailability of poorly water-soluble drugs. Despite this, they are limited by various factors such as drug-excipient miscibility, poor stability, limited drug loading and extrudability of physical drug-excipient mixtures. In this work, polyethylene glycol 8000 (PEG 8000) was used as a plasticizer for the manufacture of ellagic acid solid dispersions (EASD) with high drug loading. Indeed, EA is a polyphenolic active compound with antimalarial and other promising therapeutic activities. However, its low solubility and low permeability limit its therapeutic use. Solid dispersions formation may overcome this challenge, but its high melting point negatively influences the extrudability of its binary physical mixtures with a high drug loading rate, hence the need to use a plasticizer. Thus, five formulations consisting of EA, Eudragit® EPO and PEG 8000 in the ratio of 15:75:10 (F1), 20:70:10 (F2), 25:65:10 (F3), 15:80:5 (F4) and 20:85:5 (F5) % w/w, respectively, have been extruded, four of which were successful. The extrudates were evaluated by X-ray powder diffraction, FTIR spectroscopy and in vitro dissolution tests. Based on the results of these tests, the F5 formulation was identified as the most promising. Indeed, after 15 min of dissolution test, the dissolution rate of ellagic acid from the formulations was 62.67±3.10%, 58.74±7.23 %, 88.75±3.02% and 83.47±4.40% respectively for formulation F1, F2, F4 and F5. Moreover, the results of the FTIR spectroscopy analyses showed stronger interactions between the different constituents in the F4 and 5 formulations compared to the F1 and 2 formulations. Extruded materials of the F5 formulation, characterized by solid state nuclear magnetic resonance (ssNMR) spectroscopy and subjected to stability studies, showed good physical stability for twelve months under real-time stability study conditions and for six months under accelerated conditions