印度旁遮普邦用于改善育龄妇女和学龄前儿童微量营养素状况的五倍强化盐：一项基于社区的随机对照试验方案
Quintuply-fortified salt for the improvement of micronutrient status among women of reproductive age and preschool-aged children in Punjab, India: protocol for a randomized, controlled, community-based trial.
作者信息
McDonald Christine M, Brown Kenneth H, Goh Yvonne E, Manger Mari S, Arnold Charles D, Krebs Nancy F, Westcott Jamie, Long Julie M, Gibson Rosalind S, Jamwal Manu, Singh Bidhi L, Dahiya Neha, Budhija Deepmala, Das Reena, Duggal Mona
机构信息
Departments of Pediatrics, and Epidemiology and Biostatistics, University of California, San Francisco, CA, USA.
Department of Nutrition, and Institute for Global Nutrition, University of California, Davis, CA, USA.
出版信息
BMC Nutr. 2022 Sep 6;8(1):98. doi: 10.1186/s40795-022-00583-y.
BACKGROUND
Multiple micronutrient (MN) deficiencies remain highly prevalent among women of reproductive age (WRA) and preschool-aged children (PSC) in many areas within India. Salt is an attractive vehicle for MN fortification in this context, as it is universally consumed in fairly consistent amounts and coverage of iodized salt (IS) is 94%. The overall objective of this trial is to evaluate the nutritional impact of quintuply-fortified salt with iron in the form of encapsulated ferrous fumarate, zinc, vitamin B12, folic acid, and iodine (eFF-Q5S) vs. quintuply-fortified salt with iron in the form of ferric pyrophosphate plus EDTA, zinc, vitamin B12, folic acid, and iodine (FePP-Q5S) vs. IS for the improvement of MN status among non-pregnant WRA and PSC.
METHODS
The study is a community-based, randomized, controlled trial that will be conducted in Punjab, India. 780 non-pregnant WRA 18-49 years old and 468 PSC 12-59 months old will be enrolled and assigned to one of three intervention groups. Salt will be provided to participants monthly for 12 months. Primary outcomes include changes in mean concentration of biomarkers of iron, zinc, vitamin B12, folate and iodine. Secondary outcomes include changes in the composition of the gut microbiome, and discretionary salt intake of PSC.
DISCUSSION
If proven efficacious, multiply-fortified salt (MFS) has the potential to drastically reduce the burden of MN deficiencies in India, and around the world. Although effectiveness research will be needed to examine the impact of MFS under programmatic conditions, salt fortification will piggy-back on existing platforms to produce IS and doubly-fortified salt (DFS), making it possible to scale-up the intervention quickly.
TRIAL REGISTRATION
Clinicaltrials.gov: NCT05166980; date of registration: December 22, 2021. Clinical Trials Registry-India: CTRI/2022/040332 and CTRI/2022/02/040333; date of registration: February 15, 2022.
背景
在印度的许多地区，育龄妇女（WRA）和学龄前儿童（PSC）中多种微量营养素（MN）缺乏症仍然非常普遍。在这种情况下，盐是进行MN强化的理想载体，因为盐的消费量普遍较为稳定，且碘盐（IS）的覆盖率为94%。本试验的总体目标是评估以富马酸亚铁胶囊形式添加铁、锌、维生素B12、叶酸和碘的五重强化盐（eFF-Q5S）与以焦磷酸铁加乙二胺四乙酸形式添加铁、锌、维生素B12、叶酸和碘的五重强化盐（FePP-Q5S）以及碘盐（IS）对改善非妊娠WRA和PSC中MN状况的营养影响。
方法
该研究是一项基于社区的随机对照试验，将在印度旁遮普邦进行。将招募780名18至49岁的非妊娠WRA和468名12至59个月大的PSC，并将其分配到三个干预组之一。将每月向参与者提供盐，持续12个月。主要结局包括铁、锌、维生素B12、叶酸和碘生物标志物平均浓度的变化。次要结局包括肠道微生物群组成的变化以及PSC的 discretionary盐摄入量。
讨论
如果证明有效，多重强化盐（MFS）有可能大幅减轻印度乃至全世界MN缺乏症的负担。尽管需要进行有效性研究来检验MFS在项目条件下的影响，但盐强化将借助现有的生产碘盐（IS）和双重强化盐（DFS）的平台，从而有可能迅速扩大干预规模。
试验注册
Clinicaltrials.gov：NCT05166980；注册日期：2021年12月22日。印度临床试验注册中心：CTRI/2022/040332和CTRI/2022/02/040333；注册日期：2022年2月15日。
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