Study of Multiply-fortified Salt Among Women of Reproductive Age and Preschool Children in India
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 1,389
- 试验地点
- 1
- 主要终点
- Change in serum folate
研究概览
简要总结
Micronutrient (MN) deficiencies are highly prevalent in India, particularly among women of reproductive age (WRA) and preschool aged children (PSC). MN fortification of a staple food or condiment can be an effective strategy for improving the MN status of nutritionally vulnerable populations, as the approach is cost-effective, utilizes existing delivery systems, can deliver multiple MNs simultaneously, and does not require behavior change by the population. Salt is a particularly attractive vehicle for multiple MN fortification in India, as it is universally consumed in fairly consistent amounts; and 93% of households already use adequately iodized salt.
The overall goal of this study is to evaluate the nutritional impact of quintuply-fortified salt with iron in the form of FePP (FePP-Q5S, i.e. salt fortified with iron in the form of ferric pyrophosphate plus ethylenediaminetetraacetic acid as an enhancer of absorption; zinc in the form of zinc oxide; vitamin B12; folic acid; and iodine) vs. quintuply-fortified salt with iron in the form of eFF (eFF-Q5S i.e. salt fortified with iron in the form of encapsulated ferrous fumarate; zinc in the form of zinc oxide, vitamin B12, folic acid, and iodine) vs. iodized salt (IS) for the improvement of micronutrient status among nonpregnant WRA and preschool-aged children (12-59 months of age) in Punjab, India.
Enrolled women (and their affiliated households) will be randomized to receive 1 kg of their assigned study salt per month for 12 months, and will be instructed to use the study salt in place of their usual salt. Blood and urine samples will be collected from participant WRA and PSC at enrollment, 6 months and at the end of the 12-month intervention period. The change in the mean concentration of various MN biomarkers will be considered primary outcomes. Stool samples will also be collected from a subgroup of women and children to assess changes in the gut microbiome over the intervention period.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
Study salts will be packaged in color-coded, polyethylene bags.
入排标准
- 年龄范围
- 12 Months 至 49 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- 未提供
排除标准
- 未提供
结局指标
主要结局
Change in serum folate
时间窗: Enrollment to 12 months (i.e. end of intervention period)
Change in mean serum folate concentration
Change in urinary iodine
时间窗: Enrollment to 12 months (i.e. end of intervention period)
Change in mean urinary iodine concentration
Change in serum vitamin B12
时间窗: Enrollment to 12 months (i.e. end of intervention period)
Change in mean serum vitamin B12 concentration
Change in methylmalonic acid
时间窗: Enrollment to 12 months (i.e. end of intervention period)
Change in mean concentration of methylmalonic acid
Change in plasma zinc
时间窗: Enrollment to 12 months (i.e. end of intervention period)
Change in mean plasma zinc concentration
Change in serum ferritin
时间窗: Enrollment to 12 months (i.e. end of intervention period)
Change in inflammation-adjusted mean serum ferritin concentration
Change in soluble transferrin
时间窗: Enrollment to 12 months (i.e. end of intervention period)
Change in inflammation-adjusted mean soluble transferrin concentration
Change in holo-transcobalamin
时间窗: Enrollment to 12 months (i.e. end of intervention period)
Change in mean holo-transcobalamin concentration
Change in serum thyroglobulin
时间窗: Enrollment to 12 months (i.e. end of intervention period)
Change in mean serum thyroglobulin concentration
Change in hemoglobin
时间窗: Enrollment to 12 months (i.e. end of intervention period)
Change in mean hemoglobin concentration
Change in red blood cell folate
时间窗: Enrollment to 12 months (i.e. end of intervention period)
Change in mean red blood cell folate concentration
次要结局
- Change in gut microbiota(Enrollment to 12 months (i.e. end of intervention period))
- Change in nail zinc(Enrollment to 12 months (i.e. end of intervention period))