Optimising Malnutrition Treatment in Children 6–59 Months-OptiMA-DRC: Primary Outcome of a Randomised Control Trial in Democratic Republic of Congo

• Published in: Current developments in nutrition 2021-06, Vol.5 (Supplement_2), p.111-111
• Main Authors: Cazes, Cécile, Phelan, Kevin, Hubert, Victoire, Boubacar, Harouna, Bozama, Liévin Izie, Alitanou, Rodrigue, Tshiala, Beatrice Kalenga, Sakubu, Gilbert Tshibangu, Yao, Cyrille, Kouame, Antoine, Delphine, Gabillard, Kinda, Moumouni, Augier, Augustin, Anglaret, Xavier, Shepherd, Susan, Becquet, Renaud
• Format: Article
• Language: English
• Subjects: Community and Public Health Nutrition
• ISSN: 2475-2991; 2475-2991
• DOI: 10.1093/cdn/nzab035_019

The main objective was to compare the OptiMA strategy- ie.supplementing with ready-to-use therapeutic food at a gradually reduced doses- with the current national standard protocol. This non-inferiority, individually randomised controlled clinical trial was conducted in the Democratic Republic of Congo. Children 6–59 months with MUAC < 125 mm or weight-for-height Zscore< –3 or oedema and without medical complication were randomized to either OptiMA or standard arm and followed for 6 months. The main outcome was a binary composite indicator at 6-months post inclusion: child alive, not acutely malnourished per the study definition, and without an additional episode of acute malnutrition throughout the observation period. Non-inferiority was shown if the upper-bound of the 95% CI of the difference of proportion of favourable outcome between the two strategies was less than 10% in both intention-to-treat (ITT) and per-protocol (PP) analyses. Superiority (upper-bound of the 95% CI of this difference lower than 0%) was considered if non-inferiority was shown. Between July 2019 and July 2020, 981 children were enrolled. 896 children were included in the ITT analysis (450 OptiMA and 446 standard), 792 in the PP analysis. All children under OptiMA and 200 children in the standard arm were eligible for RUTF. ITT analysis showed 325 (72·2%) children had a favourable outcome under OptiMA versus 282 (63·2%) in the standard arm (difference: –9·2%, 95% CI: –15·9% to –2·0%). PP analysis was similar. Under OptiMA, weight and MUAC gain were greater (median weight gain, 1700 g versus 1600 g, P = 0·003 and median MUAC gain, 13 mm versus 12 mm, P = 0·012), and RUTF consumption was lower (median of 64 sachets versus 102 sachets, P = 0·018). There was no difference in hospitalization (10% OptiMA, 7% standard, P = 0·228) or mortality rates (0·2% in both arms). OptiMA was superior to the DRC standard protocol. It expanded access to RUTF, promoted improved anthropometry with lower RUTF consumption during treatment, and led to better outcomes at 6-months post inclusion. These results suggest benefits in giving smaller rations of RUTF at an earlier stage of malnutrition rather than larger rations only when children become severely malnourished. Innocent Foundation (London) European Civil Protection and Humanitarian Aid Operations (Brussels).