Palmer Amanda C, Hossain Md Iqbal, Ali Hasmot, Ayesha Kaniz, Shaikh Saijuddin, Islam Md Tanvir, Johura Fatema-Tuz, Pasqualino Monica M, Rahman Hafizur, Haque Rezwanul, Alland Kelsey, Wu Lee Shu-Fune, Schulze Kerry J, Chakraborty Subhra, West Keith P, Alam Munirul, Ahmed Tahmeed, Labrique Alain B
Department of International Health, Johns Hopkins Bloomberg School of Public Health, Baltimore, MD, United States.
icddr,b, Dhaka, Bangladesh.
Am J Clin Nutr. 2025 Mar;121(3):597-609. doi: 10.1016/j.ajcnut.2024.12.027. Epub 2025 Jan 7.
Protein requirements established for healthy populations may be insufficient to support healthy growth in infants consuming largely cereal-based complementary foods and frequently exposed to enteric pathogens.
This study aimed to assess independent and combined effects of protein supplementation and antibiotic treatment on linear growth of infants aged 6-12 mo.
We conducted a 2 × 4 factorial cluster-randomized trial in northwestern Bangladesh, allocating 566 clusters to masked azithromycin (10 mg/kg × 3 d) or placebo at 6 and 9 mo of age and unmasked delivery of an egg white protein-rich blended food supplement (250 kcal; 10 g added protein), a rice-based isocaloric supplement, egg, or nutrition education from 6 to 12 mo. We measured length at 6 and 12 mo. For this cluster-level intention-to-treat analysis of the 2 × 2 antibiotic and protein interventions, we used multiple linear or log-binomial regression with generalized estimating equations to assess changes in length-for-age z (LAZ) score and stunting (LAZ < -2), respectively.
We enrolled 2055 infants (283 clusters) and included 1821 infants (281 clusters) with complete anthropometry data at 6 and 12 mo in our analysis. There were no significant interactions between the protein and antibiotic interventions for any outcomes. Independently, protein supplement did not improve LAZ (β: 0.05; 95% CI: 0.00, 0.11; P = 0.07) or reduce stunting (prevalence ratio: 1.12; 95% CI: 0.85, 1.49; P = 0.41) compared with the isocaloric supplement. The antibiotic intervention had no effect on LAZ (β: -0.05; 95% CI: -0.11, 0.01; P = 0.09) or stunting (prevalence ratio: 0.99; 95% CI: 0.75, 1.31; P = 0.96), relative to the placebo.
Supplementation to increase intakes of high-quality protein, provided with or without presumptive treatment for enteric pathogens, did not improve linear growth from 6 to 12 mo of age. This trial was registered at clinicaltrials.gov as NCT03683667.
为健康人群确定的蛋白质需求量可能不足以支持主要食用谷类辅食且频繁接触肠道病原体的婴儿实现健康生长。
本研究旨在评估补充蛋白质和抗生素治疗对6至12月龄婴儿线性生长的独立及联合作用。
我们在孟加拉国西北部进行了一项2×4析因整群随机试验，将566个整群随机分配，在6和9月龄时给予婴儿阿奇霉素（10 mg/kg×3天）或安慰剂，且从6至12月龄时给予含蛋清蛋白的混合食品补充剂（250千卡；额外添加10克蛋白质）、等热量的大米补充剂、鸡蛋或营养教育。我们测量了婴儿6和12月龄时的身长。对于2×2抗生素和蛋白质干预措施的整群水平意向性分析，我们使用了带有广义估计方程的多元线性或对数二项回归分别评估年龄别身长z评分（LAZ）和发育迟缓（LAZ＜-2）的变化。
我们纳入了2055名婴儿（283个整群），分析中纳入了1821名在6和12月龄时有完整人体测量数据的婴儿（281个整群）。蛋白质和抗生素干预措施在任何结局方面均无显著交互作用。单独来看，与等热量补充剂相比，补充蛋白质并未改善LAZ（β：0.05；95%CI：0.00，0.11；P = 0.07）或降低发育迟缓发生率（患病率比：1.12；95%CI：0.85，1.49；P = 0.41）。与安慰剂相比，抗生素干预对LAZ（β：-0.05；95%CI：-0.11，0.01；P = 0.09）或发育迟缓（患病率比：0.99；95%CI：0.75，1.31；P = 0.96）无影响。
无论是否对肠道病原体进行推定治疗，补充以增加优质蛋白质摄入量均未改善6至12月龄婴儿的线性生长。本试验已在clinicaltrials.gov注册，注册号为NCT03683667。
