Effects of Environmental Enteric Dysfunction (EED) on Zinc (Zn) Absorption and Retention in Young Children: Study 2 - Absorption of Zn From a Multi-micronutrient Powder (MNP)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 80
- 试验地点
- 3
- 主要终点
- Total daily absorbed zinc (TAZ)
研究概览
简要总结
The overall objective is to determine the impact of EED on total daily zinc absorption of young Bangladeshi children (18-24 months of age) in an austere setting with high rates of diarrhea, stunting, and micro-nutrient deficiencies..
详细描述
Participating children are screened for EED using the lactulose:mannitol ratio test and assigned to one of two groups: +EED or -EED. After assignment to one of the two groups, proposed subjects will be randomized to one of four supplement groups: Micronutrient powder (MNP) with 15 mg Zn, MNP with 10 mg Zn, MNP with 5 mg Zn, and MNP with 0 mg Zn. Children will receive the supplement once with a meal on Day 8 of the study. Absorption of zinc from the supplement and from other non-supplemented meals will be determined using zinc stable isotope technology.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Months 至 24 Months（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Absence of apparent health problems that would impair ability to consume regular diet, to tolerate zinc supplements, or to comply with demands of metabolic studies
- •Length for age Z (LAZ) score between -1.5 to -3.0
排除标准
- •Outside age range
- •Chronic illness
- •Zinc supplement within past 2 weeks (including for treatment of diarrhea or MNP containing zinc)
- •Severe stunting and/or severe acute malnutrition (SAM): LAZ <-3; WHZ <-3 or MUAC < 115 or edema
研究组 & 干预措施
Micronutrient Powder (MNP) + 15 mg Zn
1 sachet of Micronutrient Powder (MNP) + 15 mg Zn will be added to a single meal on study day 8
干预措施: Micronutrient Powder (MNP) + 15 mg Zn (Dietary Supplement)
MNP + 10 mg Zn
1 sachet of MNP + 10 mg Zn will be added to a single meal on study day 8
干预措施: MNP + 10 mg Zn (Dietary Supplement)
MNP + 5 mg Zn
1 sachet of MNP + 5 mg Zn will be added to a single meal on study day 8
干预措施: MNP + 5 mg Zn (Dietary Supplement)
MNP without Zn
1 sachet of MNP without Zn will be added to a single meal on study day 8
干预措施: MNP without Zn (Dietary Supplement)
结局指标
主要结局
Total daily absorbed zinc (TAZ)
时间窗: 1 day
Measured during the meal to determine the effects of EED on zinc absorption.
次要结局
- Soluble transferrin receptors(1 day)
- Plasma zinc(1 day)
- Vitamin B12(1 day)
- TNF alpha(1 day)
- alpha 1 antitrypsin(1 day)
- Neopterin(1 day)
- Myeloperoxidase(1 day)
- Serum ferritin(1 day)
- Serum endocab(1 day)
- Alkaline phosphatase(1 day)
- Serum retinol(1 day)
- Methyl malonic acid(1 day)
- CRP(1 day)
- Calprotectin(1 day)
- Exchangeable zinc pool (EZP)(1 day)
- AGP(1 day)