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临床试验/NCT04565314
NCT04565314Unknown不适用

ELICIT 2.0: Pilot Study of the Effect of Maternal Protein Supplementation During Lactation on Childhood Growth

University of Virginia1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2019年11月12日最近更新:
适应症

试验速览

阶段
不适用
入组人数
100
试验地点
1
主要终点
Family perception of Plumpy'Mum

研究概览

简要总结

Haydom Global Health Research Center in north central Tanzania represents an important rural setting for performing high-quality medical research in sub-Saharan Africa. The region around Haydom is agricultural (predominantly maize-based), is resource-poor and has a high degree of stunting among local infants-with 70% stunting by 18 months in the MAL-ED study and 50% in the ELICIT study (for Early Life Interventions for Childhood Growth and Development In Tanzania). While the causes of this stunting are multifactorial, a potential contributor is early-life nutritional deficiencies, including inadequate dietary protein.

One likely source of low protein delivery to infants is from low intake among area mothers during lactation, with potential effects on breast milk protein content and child weight gain. The current study is a pilot study assessing our study team's ability to successfully deliver protein-containing food products (a balanced-energy protein supplement) to lactating mother is in the area and assessing whether consumption of these food products improves childhood growth in the 1st year of life. This is a pilot study because of the potential difficulties in distributing these products on a large scale for daily consumption. As such, we aim to demonstrate an effective distribution network, a means of assessing adherence, and measuring endpoints while gathering knowledge regarding community acceptance. The current pilot project will evaluate the effectiveness of distribution and adherence on approximately 100 mother/child dyads. If effective, a future project could involve a large enough sample to be powered to detect reasonable changes in linear growth. .

So, while the current proposal is not adequately powered to prove a hypothesis, the hypothesis underlying the study design is that daily protein supplementation delivered as a balanced protein product (Plumpy'mum) to lactating mothers for 3 months during the period from 0-6 months post-natal life will result in an increase in infant length-for-age Z-score (LAZ) by end of treatment. LAZ will be compared to controls from prior studies in the area.

详细描述

In severely under-resourced areas of the world, such as the Haydom area in Tanzania (TZ), poor nutrition continues contributes to worsened health-related outcomes including growth and cognitive development. Haydom Global Health Research Center at Haydom Lutheran Hospital in north central Tanzania represents an important rural setting for performing high-quality medical research in sub-Saharan Africa. Through ongoing work in the area around Haydom in the MAL-ED and ELICIT studies, we have been attempting to improve outcomes for children in an area of severe poverty, where there is considerable malnutrition and potential sequelae:

  1. Growth deficits: Poor weight gain and linear growth failure in childhood are often seen as surrogates for overall health status; persistently poor growth has implications for future work potential and lower human capital. There was a high degree of stunting in the Haydom site of Tanzanian in the multi-country observational MAL-ED study, which found that the Haydom site had the highest prevalence of stunting among all the MAL-ED sites. This degree of stunting is likely multi-factorial, though one contributor is food availability, as rates of key factors such as birthweight vary significantly according to food availability. An interim analysis of data from our ongoing ELICIT study (for Early Life Interventions for Childhood

Developmental delays: Perhaps there is no more important outcome (with the exception of mortality) than the cognitive, social and emotional development of a population, with clear extensions to human capital, economic productivity and quality of life in communities. Indeed, many observational and interventional studies (including the current study) follow growth as an outcome because of its overall association with cognitive development. In MAL-ED assessments, TZ children had fewer words than seen among US children. The reasons for potential developmental delays are multifactorial, but again malnutrition may play an important role. Studies in other developing areas have demonstrated improved cognitive development following delivery of nutrition support.

Nutritional Causes of Poor Growth

While the causes of the stunting and developmental delays are multifactorial, a potential contributor is early-life nutritional deficiencies, including inadequate dietary protein. One likely source of low protein delivery to infants is from low intake among area mothers during lactation, with potential effects on breast milk protein content and child weight gain. Indeed, the first six months of life represents a critical phase of nutrition for the developing infant, in which all (or nearly all) nutrition is delivered through the mother's breast milk. However, it is not known whether protein supplementation during lactation in this setting would improve childhood growth and reduce stunting-or whether any improvements in growth would continue beyond the period of maternal supplementation.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Treatment
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • Maternal age >/= 18 years
  • Current pregnancy or infant </= 3 months

排除标准

  • Maternal inability to adhere to protocol
  • Multiple gestation
  • Significant birth defect
  • Maternal allergy to peanut, milk or soy
  • Lack of breast feeding at enrollment (and lack of intention to continue breast feeding at time of enrollment

结局指标

主要结局

Family perception of Plumpy'Mum

时间窗: at 3 months after enrollment

Families will be queried about their impression of Plumpy'Mum

次要结局

  • Child head circumference-for-age Z-score (HCZ) after 3 months of Plumpy'Mum use(3 months)
  • Maternal weight at 3 months(3 months)
  • Child weight-for-age Z-score (WAZ) after 3 months of Plumpy'Mum use(3 months)
  • Child mid-upper arm circumference-for-age Z-score (MUAC-Z) after 3 months of Plumpy'Mum use(3 months)
  • Child length-for-age Z-score (LAZ) after 3 months of Plumpy'Mum use(3 months)
  • Adverse events(3 months)
  • Maternal mid-upper arm circumference-for-age Z-score (MUAC) at 3 months(12 months)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Mark D. DeBoer, MD, MSc., MCR

Professor of Pediatrics

University of Virginia

研究点 (1)

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