From the Department for International Health, University of Tampere School of Medicine, Tampere, Finland (PA, LA, UA, YBC, and UH); the Department of Paediatrics, Tampere University Hospital, Tampere, Finland (PA); Duke-National University of Singapore Graduate Medical School, Centre for Quantitative Medicine, Singapore, Singapore (YBC); the Departments of Nutrition (KGD) and Agricultural and Resource Economics (SAV), University of California, Davis, Davis, CA; the Department of Nutrition & Food Science, University of Ghana, Legon, Ghana (AL); the Department of Community Health, University of Malawi College of Medicine, Blantyre, Malawi (MN, NP, JP, and KM); and Nutriset S.A.S., Malaunay, France (MZ).
Am J Clin Nutr. 2015 Feb;101(2):387-97. doi: 10.3945/ajcn.114.088617. Epub 2014 Dec 10.
Small birth size, often associated with insufficient maternal nutrition, contributes to a large share of global child undernutrition, morbidity, and mortality. We developed a small-quantity lipid-based nutrient supplement (SQ-LNS) to enrich the diets of pregnant women.
The objective was to test a hypothesis that home fortification of pregnant women's diets with SQ-LNS would increase birth size in an African community.
We enrolled 1391 women with uncomplicated pregnancies (<20 gestational weeks) in a randomized controlled trial in Malawi. The women were provided with one daily iron-folic acid (IFA) capsule, one capsule containing multiple micronutrients (MMNs), or one 20-g sachet of SQ-LNS (LNS, containing 118 kcal, protein, carbohydrates, essential fatty acids, and 21 micronutrients). Primary outcomes were birth weight and newborn length. Secondary outcomes included newborn weight, head and arm circumference, and pregnancy duration. Analysis was by intention to treat.
The mean ± SD birth weight and newborn length were 2948 ± 432, 2964 ± 460, and 3000 ± 447 g (P = 0.258) and 49.5 ± 2.4, 49.7 ± 2.2, and 49.9 ± 2.1 cm (P = 0.104) in the IFA, MMN, and LNS groups, respectively. For newborn weight-for-age, head circumference, and arm circumference, the point estimate for the mean was also highest in the LNS group, intermediate in the MMN group, and lowest in the IFA group, but except for midupper arm circumference (P = 0.024), the differences were not statistically significant. The prevalence of low birth weight (<2500 g) was 12.7%, 13.5%, and 12.1% (P = 0.856), respectively; newborn stunting (length-for-age z score < -2) was 19.2%, 14.0%, and 14.9% (P = 0.130), respectively; and newborn small head circumference (head circumference-for-age z score < -2) was 5.8%, 3.0%, and 3.1% (P = 0.099), respectively. The associations between the intervention and the outcomes were not modified by maternal parity, age, or nutritional status (P > 0.100).
The study findings do not support a hypothesis that provision of SQ-LNS to all pregnant women would increase the mean birth size in rural Malawi. The trial was registered at clinicaltrials.gov as NCT01239693.
出生体重较小，通常与母体营养不足有关，这是导致全球儿童营养不足、发病和死亡的一个主要原因。我们研发了一种小剂量脂质基营养补充品（SQ-LNS），旨在为孕妇的饮食增添营养。
本研究旨在验证一个假设，即在家用 SQ-LNS 强化孕妇饮食可增加非洲社区的出生体重。
我们在马拉维开展了一项随机对照试验，共纳入了 1391 名孕龄＜20 周的健康孕妇。这些孕妇每日分别接受一片铁叶酸（IFA）胶囊、一片多种微量营养素（MMN）胶囊或 20 克 SQ-LNS 小袋（含 118 千卡热量、蛋白质、碳水化合物、必需脂肪酸和 21 种微量营养素）。主要结局指标为出生体重和新生儿身长。次要结局指标包括新生儿体重、头围和臂围以及妊娠持续时间。分析采用意向治疗。
IFA、MMN 和 LNS 组的平均出生体重和新生儿身长分别为 2948±432、2964±460 和 3000±447 g（P=0.258）和 49.5±2.4、49.7±2.2 和 49.9±2.1 cm（P=0.104）。对于新生儿体重/年龄、头围和臂围，LNS 组的均值估计值最高，MMN 组次之，IFA 组最低，但除了中上臂围（P=0.024）外，其他差异均无统计学意义。低出生体重（＜2500 g）的发生率分别为 12.7%、13.5%和 12.1%（P=0.856）；新生儿生长迟缓（身长/年龄 z 评分＜-2）的发生率分别为 19.2%、14.0%和 14.9%（P=0.130）；新生儿小头颅（头围/年龄 z 评分＜-2）的发生率分别为 5.8%、3.0%和 3.1%（P=0.099）。干预与结局之间的关联不受孕产妇产次、年龄或营养状况的影响（P＞0.100）。
本研究结果不支持在家用 SQ-LNS 强化所有孕妇饮食可增加马拉维农村地区平均出生体重的假设。该试验已在 clinicaltrials.gov 上注册，编号为 NCT01239693。
