Randomized Controlled Trial in South Africa Comparing the Efficacy of Complementary Food Products on Child Growth
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 750
- 试验地点
- 1
- 主要终点
- Linear growth by measuring length
研究概览
简要总结
Complementary food supplements (CFS), fortified products that are mixed with the infant's usual complementary foods, have the potential to improve nutrition among infants. In Africa, maize is a major staple food used for complementary feeding. Compared to rice or wheat, maize has higher levels of phytates, which bind trace elements such as iron and zinc, and inhibit their absorption. The impact of CFS products in the context of a maize-based diet has not been well investigated. This study will test two newly developed fat-based CFS products made from soy.
The first product is a fortified fat-based spread that contains essential fatty acids with added docosahexaenoic acid (DHA) and arachidonic acid (ARA), and phytase to improve iron and zinc bioavailability. The second product is a fortified fat-based product containing essential fatty acids. Both products contain soy. The enrichment of the products with essential fatty acids is of particular interest in the South African context, as consumers are exposed to higher linoleic acid (LA) diets due to the inclusion of mostly high LA-containing sunflower oil during food preparation. The CFS products could contribute towards restoring the balance between LA and alpha-linolenic acid (ALA) intake.
The results of this study will provide evidence on whether or not two types of fortified CFS have the potential to address malnutrition (linear growth) and improve psychomotor development in infants. If proven effective, this approach of providing multiple nutrients can be made available to infants in the developing world and may lead to sustainable actions.
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 6 Months(Child)
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Infants resident in the study area
- •Aged 6 months
排除标准
- •Severe obvious congenital abnormalities
- •Severe anaemia (haemoglobin < 70 g/L)
- •Severe malnutrition (weight-for-length Z-score <-3.00)
- •Other diseases referred for hospitalization by clinic staff
- •Plans to move out of the study area in the next 7 months
- •Known food allergies/intolerances e.g. to peanuts, milk and fish
- •Infants given special nutritional supplements
- •Infants known to be HIV+
- •Not been borne as a singleton
研究组 & 干预措施
Fortified fat-based paste with EFAs, DHA, ARA and phytase
Complementary food supplement providing micronutrients and both essential fatty acids, DHA, ARA, phytase and L-lysine, potassium, phosphorous, magnesium and manganese
干预措施: Fortified fat-based paste with essential fatty acids, DHA, ARA, phytase, L-lysine, potassium, phosphorous, magnesium and manganese (Dietary Supplement)
Fortified fat-based paste with essential fatty acids
Complementary food supplement providing micronutrients and essential fatty acids (EFAs)
干预措施: Fortified fat-based paste with essential fatty acids (Dietary Supplement)
Control group
The control group will receive a delayed intervention
结局指标
主要结局
Linear growth by measuring length
时间窗: 6 months
To assess the effects of two different fortified fat-based complementary food supplements on linear growth compared to a control
次要结局
- Psychomotor-motor development measured by the Kilifi Developmental Inventory and Parent rating (gross motor skills) at baseline and end. Motor milestones chart (weekly)(6 months)
- Measures of anemia, essential fatty acid, iron and iodine status(6 months)
- Growth by measuring weight of infant (bi-monthly, mid-upper arm circumference (MUAC) and head circumference of infant (baseline and end)(6 month)
研究者
Marius Smuts
Professor
North-West University, South Africa
