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

North-West University, South Africa

Status: Completed

Conditions: Malnutrition

Treatments: Dietary Supplement: 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

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT01845610

TSWAKA

Details and patient eligibility

About

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.

Enrollment: 750 patients

Sex: All

Ages: 6 to 6 months old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Infants resident in the study area
• Aged 6 months

Exclusion criteria

• 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

---

750 participants in 3 patient groups

Fortified fat-based paste with EFAs, DHA, ARA and phytase

Experimental group

Description:

Complementary food supplement providing micronutrients and both essential fatty acids, DHA, ARA, phytase and L-lysine, potassium, phosphorous, magnesium and manganese

Treatment:

Dietary Supplement: Fortified fat-based paste with essential fatty acids, DHA, ARA, phytase, L-lysine, potassium, phosphorous, magnesium and manganese

Fortified fat-based paste with essential fatty acids

Experimental group

Description:

Complementary food supplement providing micronutrients and essential fatty acids (EFAs)

Treatment:

Dietary Supplement: Fortified fat-based paste with essential fatty acids

Control group

No Intervention group

Description:

The control group will receive a delayed intervention