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临床试验/NCT05168085
NCT05168085进行中(未招募)不适用

Randomised Controlled Trial to Test and Build Evidence Base for Providing Eggs as an Early Complementary Food to Promote Child Growth: Eggcel-growth Study

North-West University, South Africa2 个研究点 分布在 1 个国家目标入组 655 人开始时间: 2020年2月13日最近更新:
适应症

试验速览

阶段
不适用
状态
进行中(未招募)
发起方
入组人数
655
试验地点
2
主要终点
Linear growth by measuring length

研究概览

简要总结

This study will investigate the efficacy of providing one chicken egg per day for a period of 6 months, beginning at the age of 6 to <9 months on the growth, motor development, micronutrient, and morbidity status of infants from a low socioeconomic community in South Africa.

详细描述

The nutritional benefit of eggs, in particular chicken eggs is well documented. However, there is paucity of evidence regarding including eggs, in particular chicken eggs during the early complementary feeding phase to enhance child growth and development. Thus, this study seeks to determine and to provide evidence on the effectiveness of including chicken eggs as an early complementary food to enhance early child growth and development. This randomised controlled trial will contribute towards building a strong evidence for the promotion and use of eggs as a healthy and nutritious early complementary food, and can be used to inform future programming regarding infant and young child feeding in low- and middle-income countries.

This is a randomised controlled trial with a parallel design (2 groups). Five hundred infants aged 6 to <9 months will be included. Infants with egg allergy or sensitization will be excluded. Data will be collected in three months' interval for six months. At baseline, body measurements of mother and infant will be taken; infant's dietary intake using 24-hour recall methods; breastfeeding and complementary feeding practices; infant and maternal allergy and maternal depression with structured questionnaires. Morbidity symptoms and compliance will be recorded daily and followed up weekly. Developmental milestones will be assessed weekly using Pictorial Gross Motor Milestone Chart. Household food security will be assessed. Capillary blood will be collected by means of finger and/or heal prick. This will be a community driven project. Data will be analysed according to intention to treat.

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
Single (Outcomes Assessor)

入排标准

年龄范围
6 Months 至 9 Months(Child)
性别
All
接受健康志愿者

入选标准

  • Resident in the study municipality; Infants aged 6 to <9 months

排除标准

  • Severe obvious congenital abnormalities such as cleft lip and spina bifida; Severe anaemia (haemoglobin <70 g/L); Severe acute malnutrition (weight-for-length z-score < -3); Plans to move out of the study area in the next nine months; Known allergies/intolerances to eggs; Infants receiving special nutritional supplements as part of feeding programmes; Not been born as a singleton; Mother/legal guardian below 18 years old at the start of the study

结局指标

主要结局

Linear growth by measuring length

时间窗: 6 months

Efficacy of providing one chicken egg per day on linear growth and stunting prevalence compare to a control

次要结局

  • Morbidity status(6 months)
  • Motor development using Pictorial Gross Motor Milestone Chart(6 months)
  • Biomarkers of anaemia, iron, vitamin A and essential fatty acids(6 months)

研究者

发起方
North-West University, South Africa
申办方类型
Other
责任方
Principal Investigator
主要研究者

Marius Smuts

Professor

North-West University, South Africa

研究点 (2)

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