Egg to Ameliorate Environmental Enteric Dysfunction and Improve Growth in Children With Moderate Acute Malnutrition
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 461
- 试验地点
- 10
- 主要终点
- Percent lactulose excretion
研究概览
简要总结
The goal of this clinical trial is to test egg powder supplementation in children with moderate acute malnutrition in Sierra Leone. The main question it aims to answer is:
- Will provision of 15g of whole egg powder per day during and after treatment for moderate acute malnutrition (for 24 weeks total) improve small intestinal permeability and linear growth among 6-30 month old Sierra Leonean children compared with daily corn powder supplementation?
详细描述
Undernutrition in children manifests as wasting, stunting, or both. While wasting is generally responsive to high-quality nutritional interventions, stunting is less so. Affected children are at increased risk of acute and chronic illnesses, have reduced neurocognitive development, lower academic achievement, reduced adult earning potential, and shortened lifespans. Given that stunting affects over 140 million children at any one time, the costs incurred are deep and broad, particularly among children in sub-Saharan Africa, where nearly half of the world's population growth is expected to occur over the next 30 years. Part of the challenge of treating stunting has been attributed to environmental enteric dysfunction (EED), an acquired small intestine disorder characterized by chronic inflammation, villus blunting, and impaired nutrient absorption. EED is prevalent in the same populations plagued by stunting, develops concurrently with loss in linear growth, and has explained upwards of 43% of observed growth faltering. EED has recently also been found in over 75% of children with moderate acute malnutrition (MAM, moderate wasting) in Sierra Leone, a population with high rates of deterioration to severe acute malnutrition and death, 20%. EED is a plausible cause for this treatment resistance, and for the high rates of recurrence seen in these children. There is an urgent need to increase understanding of the concurrence of stunting, EED, and wasting, and to test interventions targeted to their pathological underpinnings. Dietary egg can play a critical role in the fight against malnutrition by providing abundant high-quality protein and nutrients essential for physical and cognitive recovery. One egg/day has been shown to reduce stunting in several contexts. Recent evidence has shown that short-term egg/bovine colostrum supplement given to 9-12-month-old Malawian children improved linear growth and intestinal permeability in children with severe EED. It is possible that prolonged supplementation with egg in a high-risk population in rural Sierra Leone could improve acute and long-term health trajectories for children and put eggs on the map for food aid. This will be a randomized, investigator-blinded, controlled clinical trial testing whether daily supplementation with 15g whole egg powder during and for 18 weeks after treatment for moderate acute malnutrition might reduce intestinal permeability and improve linear growth, among other outcomes, when compared with control corn powder. Children with relatively higher risk MAM will be enrolled (MUAC < 12.5 cm AND MUACz < -2), treated with Supercereal Plus for up to 6 weeks, and undergo urine and stool collections at 6, 12, and 24 weeks. Urine collections will be for assessment of lactulose permeability and will involve participant consumption of a known amount of lactulose and collection of all urine over at least 4 hours thereafter. Stool collections will be for fecal host mRNA transcripts and selected proteins. Participants will also receive intermittent malaria chemoprophylaxis.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Investigator, Outcomes Assessor)
盲法说明
The intervention and control powders will be packaged such that investigators and outcomes assessors will not know their identity. Participants and care providers are likely to be able to distinguish them, however.
入排标准
- 年龄范围
- 6 Months 至 30 Months(Child)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •At least 6 months of age and less than 30 months of age
- •Mid-upper arm circumference >= 11.5cm and <
- •Mid-upper arm circumference-for-age z-score < -2
- •Provision of signed (or thumb-printed) and dated informed consent form
- •Stated willingness to comply with all study procedures and availability for the duration of the study, including no plan to move from the catchment area of a participating clinic
排除标准
- •Nutritional edema
- •Simultaneous involvement in another research trial or supplementary feeding program
- •Chronic debilitating illness
- •Allergy to egg
- •Receipt of treatment for acute malnutrition within 1 month prior to screening
研究组 & 干预措施
Egg powder
15g egg powder per day for 24 weeks
干预措施: Micronutrient sprinkles (Dietary Supplement)
Egg powder
15g egg powder per day for 24 weeks
干预措施: Whole egg powder (Dietary Supplement)
Egg powder
15g egg powder per day for 24 weeks
干预措施: Supercereal Plus (Dietary Supplement)
Egg powder
15g egg powder per day for 24 weeks
干预措施: Sulfadoxine pyrimethamine (Drug)
Corn powder
15g corn powder per day for 24 weeks
干预措施: Corn powder (Dietary Supplement)
Corn powder
15g corn powder per day for 24 weeks
干预措施: Supercereal Plus (Dietary Supplement)
Corn powder
15g corn powder per day for 24 weeks
干预措施: Micronutrient sprinkles (Dietary Supplement)
Corn powder
15g corn powder per day for 24 weeks
干预措施: Sulfadoxine pyrimethamine (Drug)
结局指标
主要结局
Percent lactulose excretion
时间窗: Collected 12 and 24 weeks after enrollment
Percent lactulose excretion in urine over \>=4 hours after lactulose consumption
Change in length-for-age z-score
时间窗: To be compared at 12 and 24 weeks after enrollment
Difference in length-for-age z-score between enrollment and weeks 12 and 24
次要结局
- Fecal host mRNA transcripts(Collected 12 and 24 weeks after enrollment)
- Recurrence of MAM(Time-to-event across follow-up period)
- Sustained recovery(Across 24 week follow-up period)
- Graduation(Within 6 weeks of enrollment)
- LAZ < -2(To be compared at 12, 18, and 24 weeks after enrollment)
- Fecal host protein alpha-1 antitrypsin(Collected 12 and 24 weeks after enrollment)
- Fecal host protein neopterin(Collected 12 and 24 weeks after enrollment)
- Fecal host protein myeloperoxidase(Collected 12 and 24 weeks after enrollment)
- Rate of weight gain(Enrollment to week 6 (MAM treatment phase), and across 24 week follow-up period)
- Percent Lactulose excretion(6 weeks after enrollment)
- Deterioration to severe acute malnutrition(Time-to-event across follow-up period)
- Percent Lactulose excretion >= 0.2 and >=0.45(Collected 6, 12, and 24 weeks after enrollment)
- Rate of length gain(Across 24 week follow-up period)
- Death(Time-to-event across follow-up period)
