ω3 Long-chain Polyunsaturated Fatty Acids for Healthy Growth and Development of Infants and Young Children in the Gilgel Gibe Hydroelectric Dam Area, Ethiopia.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 720
- 试验地点
- 1
- 主要终点
- Change in length-for-age Z-score over time up to 12 months.
研究概览
简要总结
New approaches are needed to prevent growth failure in children from low- and middle-income countries (LMIC). To date, nutrition intervention studies have focused on micronutrient and energy content of complementary foods and have yielded only small to moderate effects on growth and development. There appears to be a missing link that mediates and reduces the expected beneficial effect. Child populations in LMIC show an asymptomatic environmental enteropathy that is characterized by a reduced size of the small intestinal villi, decreased gut integrity and a chronic inflammatory response in the gut. Results from studies in industrialized countries suggest that ω3 long-chain polyunsaturated fatty acids (ω3 LCPUFAs) improve immune response and gut integrity. These reported beneficial effects could result in even more important physiological implications for children from LMIC and will ultimately contribute to their healthy growth and development.
The hypothesis of the OME³Jim study is that an increased intake of ω3 LCPUFAs through complementary foods and human milk has an effect on infant growth and development in a context of high malnutrition rates and low ω3 LCPUFAs intake. This study will identify whether intake by either or both mother and infant is more effective.
The specific objectives of the OME³Jim study are:
- To test the effect of supplementing infants with an ω3 LCPUFAs fortified food supplement on infant growth, morbidity, nutritional status and development;
- To test the effect of supplementing lactating mothers with an ω3 LCPUFAs oil capsule on infant growth, nutritional status and development;
- To test the combined effect (dose response) of supplementing ω3 LCPUFAs to lactating mothers and infant on infant growth, morbidity, nutritional status and development:
- To test the effect of ω3 LCPUFAs supplementation on ω3 LCPUFA status in infants and human milk.
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)
入排标准
- 年龄范围
- 6 Months 至 12 Months（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Singleton infants
- •6-12 months old
- •Not suffering from acute malnutrition (wasting): WHZ > -2 , no edema
- •Infants currently being breastfed
- •Anticipated local residence for the study duration
- •Not planning to leave the study area for more than 1 month
排除标准
- •Current supplement use or medical treatment of infant and/or mother
- •Infants developing severe anemia (<70 g/L) or edema are referred to the nearby health institution for evaluation and treatment, and are omitted from the trial
- •Presence of congenital abnormalities
结局指标
主要结局
Change in length-for-age Z-score over time up to 12 months.
时间窗: Every month since baseline until 12 months.
Length-for-age Z-score using the WHO 2006 growth reference chart.
Development score after study inclusion until 12 months after inclusion.
时间窗: 6-monthly since baseline up to 12 months.
Development score: Denver II test and Ages-Stages Social-Emotional Questionnaire.
次要结局
- Weight-for-length Z-score up to 12 months.(6-monthly up to 12 months.)
- Prevalence of stunting (HAZ <-2- up to 12 months after inclusion.(6-monthly until 12 months after inclusion.)
- C-reactive protein concentration until 12 months after inclusion(6-monthly until 12 months after inclusion)
- Mid-upper arm circumference up to 12 months after inclusion.(Monthly until 12 months after inclusion.)
- Prevalence of wasting (WHZ <-2) until 12 months after inclusion.(6-monthly until 12 months after inclusion)
- Infant morbidity at weekly intervals.(weekly until 12 months after inclusion)
- Infant blood concentrations of DHA/EPA/AA until 12 months after inclusion.(6-monthly until 12 months after inclusion)
- Breast milk concentrations of DHA/EPA/AA until 12 months after inclusion(6-monthly until 12 months after inclusion)
- Head circumference up to 12 months after inclusion(Monthly up to 12 months after inclusion)
- Haemoglobin concentration until 12 months(6-monthly until 12 months after inclusion)