跳至主要内容
临床试验/NCT01845610
NCT01845610已完成不适用

Randomized Controlled Trial in South Africa Comparing the Efficacy of Complementary Food Products on Child Growth

North-West University, South Africa1 个研究点 分布在 1 个国家目标入组 750 人开始时间: 2013年9月1日最近更新:
适应症
干预措施

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

Experimental

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

Experimental

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

No Intervention

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

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 (1)

Loading locations...

相似试验