Khadilkar Anuradha, Rawat Vinay, Bhatt Jaladhi, Chaturvedi Devyani, Garg Vivek, Verma Pankaj
Jehangir Clinical Development Centre, Jehangir Hospital Premises, Bund Garden Road, Sangamvadi, Pune, India, 91 9850244305.
GlaxoSmithKline Consumer Healthcare Limited, Gurgaon, India.
Interact J Med Res. 2025 Jun 25;14:e54189. doi: 10.2196/54189.
Nutritional inadequacy and consequent diminished immunity among school-age children is a public health problem in India. Nutrition interventional studies using a cluster randomized controlled trial (RCT) design can avoid ethical issues inherent in double-blind individual RCTs in children involving daily administration of an empty-calorie placebo.
We tested the hypothesis that daily administration of a fortified malt-based food (FMBF), a multinutrient supplement, would improve immunity outcomes against common infectious diseases, nutritional status, and gut health in Indian school-age children by using a cluster RCT design. This report presents the study design attributes and the baseline characteristics of the study population.
This was an open-label, 2-arm, parallel-group, matched-pair cluster RCT, stratified by gender, in children aged ≥7 to ≤10 years old with height-for-age z scores (HAZ) of ≥-3 to ≤-1 and good general health. Four schools located in Pune city in India participated in the study. Each school was deemed as a cluster and was randomized to the test group (FMBF and dietary counseling) or control group (dietary counseling alone). A total of 924 participants from the 4 randomized schools were enrolled in the study.
Observed mean age (SD) was 8.0 (SD 0.81; range: 7-10) years. There was no significant difference in mean age (P=.06), gender (P=.55), race (P>.99), HAZ category (P=.051), HAZ (P=.17), and BMI (P=.03). A very large proportion of children had micronutrient inadequacies in terms of vitamin D (97.5%), folate (79.2%), zinc (66%), and vitamin A (34.3%) at baseline. The study design meant that administration of the study intervention at a cluster level was easy. Mean compliance with the test product was 99.99% and retention in the study was 98%.
The findings highlight the extent of nutritional inadequacies in Indian school-age children, reaffirming the need for nutritional strategies to optimize the nutritional status among these children. A cluster RCT design can be effectively used in nutritional intervention trials with children by maintaining high compliance and retention.
在印度，学龄儿童营养不足以及由此导致的免疫力下降是一个公共卫生问题。采用整群随机对照试验（RCT）设计的营养干预研究可以避免在儿童双盲个体RCT中每天给予无营养热量安慰剂所固有的伦理问题。
我们检验了这样一个假设，即通过整群RCT设计，每天给予一种强化麦芽基食品（FMBF），一种多种营养素补充剂，可改善印度学龄儿童针对常见传染病的免疫结果、营养状况和肠道健康。本报告介绍了研究设计特点和研究人群的基线特征。
这是一项开放标签、双臂、平行组、配对整群RCT，按性别分层，研究对象为年龄≥7至≤10岁、年龄别身高z评分（HAZ）≥-3至≤-1且总体健康状况良好的儿童。印度浦那市的四所学校参与了该研究。每所学校被视为一个整群，并随机分为试验组（FMBF和饮食咨询）或对照组（仅饮食咨询）。来自这4所随机分组学校的924名参与者被纳入研究。
观察到的平均年龄（标准差）为8.0（标准差0.81；范围：7-10）岁。平均年龄（P=0.06）、性别（P=0.55）、种族（P>0.99）、HAZ类别（P=0.051）、HAZ（P=0.17）和BMI（P=0.03）方面均无显著差异。在基线时，很大比例的儿童存在维生素D（97.5%）、叶酸（79.2%）、锌（66%）和维生素A（34.3%）等微量营养素不足的情况。该研究设计意味着在整群水平上实施研究干预很容易。对试验产品的平均依从性为99.99%，研究中的保留率为98%。
研究结果突出了印度学龄儿童营养不足的程度，再次强调了需要采取营养策略来优化这些儿童的营养状况。整群RCT设计通过保持高依从性和保留率，可有效地用于儿童营养干预试验。
Zotero 插件