A Single-centre, Randomised, Single-blind, Parallel Group Clinical Trial in Rural Malawi, Testing the Growth Promoting Effect of Long-term Complementary Feeding of Infants With a High-energy, Micronutrient Fortified Spread
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 840
- 试验地点
- 1
- 主要终点
- Incidence of severe stunting (Length-for-age Z score < -3)
研究概览
简要总结
This study tests the hypothesis that infants receiving milk-powder containing fortified spread (lipid-based nutrient supplement) as a complementary food for one year have lower incidence of severe stunting (poor length gain) than infants who are provided with no extra food supplements or maize-soy flour for complementary porridge.
详细描述
Poor growth and severe childhood stunting is very common in rural Malawi and elsewhere in Sub-Sahara Africa. To date, few interventions have proven successful in promoting linear growth in early childhood. Our preliminary results from Malawi suggest that a year-long daily complementary feeding of infants with a high-energy, micronutrient-fortified spread (FS) may markedly reduce the incidence of severe stunting before the age of 18 months. In the present study the investigators will more carefully analyze the efficacy in linear growth promotion and other health benefits of this product when provided as a complementary food to infants between 6 and 18 months of age.
The study will be conducted in Lungwena area, Mangochi District, rural Malawi. Six-month old healthy infants are identified through community surveys in the study area. 840 infants meeting set criteria are randomized into receiving the following intervention between 6 and 18 months of age: 1) standard treatment ie no extra food supplements (but dietary supplementation between 18 and 30 months of age) (ST-DI, control group), 2), "standard" fortified spread with milk-powder as the protein source (FSm), 3) modified fortified spread with soy-powder as the protein source (FSs), or 4) fortified maize-soy flour (likuni phala, LP). The families receive the food supplements at 2-weekly intervals and the participants undergo an anthropometric and developmental evaluation and laboratory analyses at 12-week intervals. Outcome analyses are done at 18 and at 36 months of age.
The impact of the dietary interventions will be primarily assessed by comparing the incidence of severe stunting in the four study groups. Secondary outcomes include a number of anthropometric variables, morbidity, developmental milestones, and laboratory parameters. The study will also produce descriptive data on possible mechanisms for growth failure among the trial subjects.
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
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 6 Months 至 6 Months（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Signed informed consent from at least one guardian
- •Age 5.50 months to 6.49 months
- •Availability during the period of the study.
- •Permanent resident of Lungwena Health Centre or Malindi Hospital catchment area
排除标准
- •Existing or imminent severe stunting (HAZ < -2.8)
- •Weight for length (WFH) < 80% of the reference median or presence of oedema
- •Severe illness warranting hospital referral.
- •History of allergy towards peanut
- •History of anaphylaxis or serious allergic reaction to any substance, requiring emergency medical care
- •Concurrent participation in any other clinical trial
结局指标
主要结局
Incidence of severe stunting (Length-for-age Z score < -3)
时间窗: 1 year after enrolment
Incidence of serious and non-serious adverse events
时间窗: 1 year
次要结局
- Incidence of febrile illnesses and laboratory diagnosed malaria(1 year)
- Morbidity for respiratory infections, diarrhea, and other illnesses(1 year)
- Incidence of moderate or severe stunting (Length-for-age Z-score < -2)(1 year)
- Length gain (cm)(1 year)
- Weight gain (g)(1 year)
- Change in anthropometric indices (Weight-for-age Z-score, Weight-for-length Z-score, Length-for-age Z-score), mid-upper arm circumference and head circumference(1 year)
- Incidence of moderate or severe underweight or wasting (Weight-for-age Z-score or Weight-for-length Z-score <-2 / -3 SD units)(1 year)
- Blood haemoglobin, serum ferritin, vitamin A, and zinc concentration(18 months of age)
- Motor, social, and language development (timing of acquisition of defined skills)(1 year)
研究者
Per Ashorn
Professor of International Health
Tampere University