Division of Nutritional Sciences, Cornell University, Ithaca, NY, USA; Institute for Nutritional Sciences, Global Health, and Technology (INSiGHT), Cornell University, Ithaca, NY, USA.
Division of Nutritional Sciences, Cornell University, Ithaca, NY, USA.
Clin Nutr. 2022 Apr;41(4):937-947. doi: 10.1016/j.clnu.2022.02.014. Epub 2022 Feb 24.
BACKGROUND & AIMS: Biofortification of staple crops with higher levels of micronutrients via traditional breeding methods is a sustainable strategy and can possibly complement fortification and other interventions to target micronutrient deficiencies in low resource settings, particularly among vulnerable populations such as children. We aimed to determine if iron- and zinc-biofortified pearl millet (FeZnPM, Dhanashakti, ICTP-8203Fe)-based complementary feeding improves nutritional status, including iron biomarkers and growth, in children living in urban slums of Mumbai.
We conducted a randomized controlled trial of FeZnPM among 223 children aged 12-18 months who were not severely anemic at baseline (hemoglobin ≥9.0 g/dL). Children were randomized to receive either FeZnPM or conventional non-biofortified pearl millet (CPM) daily for 9 months. Iron status (hemoglobin, serum ferritin), plasma zinc, and anthropometric indicators (length, weight, mid-upper arm circumference, triceps and subscapular skinfolds) were evaluated at enrollment and throughout the trial. World Health Organization (WHO) anthropometric z-scores were calculated using WHO growth standards. Primary outcomes were hemoglobin and serum ferritin concentrations, and growth, defined as WHO z-scores. An intent to treat approach was used for analyses. We used the Hodges-Lehmann-Sen test to assess the change in primary outcomes between baseline and the last visit and report corresponding 95% confidence intervals.
At baseline, 67.7% of children were anemic (hemoglobin <11.0 g/dL) and 59.6% were iron deficient (serum ferritin <12.0 μg/L). FeZnPM did not significantly increase iron biomarkers or improve growth, compared to CPM. In subgroup analyses, FeZnPM improved hemoglobin concentrations in male children, and in children with iron deficiency or iron depletion (serum ferritin <25.0 μg/L) at baseline, relative to CPM.
Daily consumption of FeZnPM-based complementary foods did not significantly impact iron and zinc status or growth in children living in Mumbai's urban slums. However, the intervention significantly improved hemoglobin concentrations among male children and among individuals who were iron-deficient or iron-depleted at baseline.
This trial is registered with Clinicaltrials.gov (ID: NCT02233764), and Clinical Trials Registry of India (ID: REF/2014/10/007731).
通过传统的育种方法，在主要粮食作物中进行更高水平的微量营养素生物强化，是一种可持续的策略，可能有助于补充强化和其他干预措施，以解决资源匮乏环境中（尤其是在儿童等弱势群体中）的微量营养素缺乏问题。我们旨在确定基于铁锌生物强化珍珠 millet（FeZnPM，Dhanashakti，ICTP-8203Fe）的补充喂养是否能改善营养状况，包括铁生物标志物和生长，在孟买城市贫民窟生活的儿童中。
我们对 223 名年龄在 12-18 个月之间、基线时没有严重贫血（血红蛋白≥9.0g/dL）的儿童进行了 FeZnPM 的随机对照试验。儿童被随机分配每天接受 FeZnPM 或常规非生物强化珍珠 millet（CPM），共 9 个月。在入组时和整个试验期间，评估铁状态（血红蛋白、血清铁蛋白）、血浆锌和人体测量指标（长度、体重、中上臂围、三头肌和肩胛下角皮褶）。使用世界卫生组织（WHO）生长标准计算 WHO 人体测量 z 分数。主要结局是血红蛋白和血清铁蛋白浓度以及生长，定义为 WHO z 分数。采用意向治疗方法进行分析。我们使用 Hodges-Lehmann-Sen 检验评估主要结局在基线和最后一次访问之间的变化，并报告相应的 95%置信区间。
基线时，67.7%的儿童贫血（血红蛋白<11.0g/dL），59.6%的儿童缺铁（血清铁蛋白<12.0μg/L）。与 CPM 相比，FeZnPM 并未显著增加铁生物标志物或改善生长。在亚组分析中，与 CPM 相比，FeZnPM 改善了基线时男性儿童以及缺铁或铁耗竭（血清铁蛋白<25.0μg/L）儿童的血红蛋白浓度。
在孟买城市贫民窟生活的儿童中，每日食用基于 FeZnPM 的补充食品并未显著影响铁和锌的状况或生长。然而，该干预措施显著提高了男性儿童以及基线时缺铁或铁耗竭的个体的血红蛋白浓度。
该试验在 Clinicaltrials.gov（ID：NCT02233764）和印度临床试验注册处（ID：REF/2014/10/007731）注册。
