Overview

This trial is active, not recruiting.

Condition malnutrition
Treatments 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
Phase phase 2
Sponsor North-West University, South Africa
Collaborator Global Alliance for Improved Nutrition
Start date September 2013
End date December 2016
Trial size 750 participants
Trial identifier NCT01845610, TSWAKA

Summary

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking single blind (outcomes assessor)
Primary purpose treatment
Arm
(Experimental)
Complementary food supplement providing micronutrients and both essential fatty acids, DHA, ARA, phytase and L-lysine, potassium, phosphorous, magnesium and manganese
fortified fat-based paste with essential fatty acids, dha, ara, phytase, l-lysine, potassium, phosphorous, magnesium and manganese
Complementary food supplement providing micronutrients, essential fatty acids, DHA and ARA, phytase, L-lysine, potassium, phosphorous, magnesium and manganese
(Experimental)
Complementary food supplement providing micronutrients and essential fatty acids (EFAs)
fortified fat-based paste with essential fatty acids
Complementary food supplement fortified with micronutrients and essential fatty acids
(No Intervention)
The control group will receive a delayed intervention

Primary Outcomes

Measure
Linear growth by measuring length
time frame: 6 months

Secondary Outcomes

Measure
Psychomotor-motor development measured by the Kilifi Developmental Inventory and Parent rating (gross motor skills) at baseline and end. Motor milestones chart (weekly)
time frame: 6 months
Measures of anemia, essential fatty acid, iron and iodine status
time frame: 6 months
Growth by measuring weight of infant (bi-monthly, mid-upper arm circumference (MUAC) and head circumference of infant (baseline and end)
time frame: 6 month

Eligibility Criteria

Male or female participants from 6 months up to 6 months old.

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

Additional Information

Official title Randomized Controlled Trial in South Africa Comparing the Efficacy of Complementary Food Products on Child Growth
Principal investigator Cornelius M Smuts, PhD
Trial information was received from ClinicalTrials.gov and was last updated in May 2015.
Information provided to ClinicalTrials.gov by North-West University, South Africa.