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

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.

Study Overview

• Status: Completed
• Conditions: Malnutrition
• Intervention / Treatment: 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
• Enrollment (Actual): 750
• Phase: Not Applicable

Contacts and Locations

Study Locations

• South Africa
  • North-West
    • Jouberton, North-West, South Africa
      • Jouberton area of the greater Matlosana Municipality

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 6 months to 6 months (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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	Dietary supplement: 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: Fortified fat-based paste with essential fatty acids; Complementary food supplement providing micronutrients and essential fatty acids (EFAs)	Dietary supplement: Fortified fat-based paste with essential fatty acids; Complementary food supplement fortified with micronutrients and essential fatty acids
No Intervention: Control group; The control group will receive a delayed intervention

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Linear growth by measuring length	To assess the effects of two different fortified fat-based complementary food supplements on linear growth compared to a control	6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Psychomotor-motor development measured by the Kilifi Developmental Inventory and Parent rating (gross motor skills) at baseline and end. Motor milestones chart (weekly)	To investigate the effects of two different fortified fat-based complementary food supplements on psycho-motor development of infants compared to a control group.	6 months
Measures of anemia, essential fatty acid, iron and iodine status	To investigate the effects of two different fortified fat-based complementary food supplements on anemia, essential fatty acid, iron and iodine status of infants compared to a control group.	6 months
Growth by measuring weight of infant (bi-monthly, mid-upper arm circumference (MUAC) and head circumference of infant (baseline and end)	To assess the effects of two different fortified fat-based complementary food supplements on weight, MUAC and head circumference of infants	6 month

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Safety	Safety will be assessed by recording (serious) adverse events [(S)AEs]. This is comprised in the Record Morbidity activity. Episodes of vomit, diarrheal, upper respiratory diseases, fever and rush will be weekly monitoring and recording. A morbidity questionnaire has been purposely developed.	6 months
Nutritional status of mothers/caregivers	Mothers/caregivers height and weight, and a breast milk and urine sample of mothers will be taken at baseline as a reflection of their nutritional status.	6 months
Acceptability	Acceptability of complementary food supplements will be assessed before the start of the intervention trial	1 month
Dietary assessment	Multiple pass 24-hr recall (baseline and end)	6 months

Collaborators and Investigators

• Sponsor: North-West University, South Africa
• Collaborators: Global Alliance for Improved Nutrition; Unilever R&D; DSM Ltd
• Investigators: Principal Investigator: Cornelius M Smuts, PhD, North-West University, South Africa

Publications and helpful links

General Publications

• Smuts CM, Matsungo TM, Malan L, Kruger HS, Rothman M, Kvalsvig JD, Covic N, Joosten K, Osendarp SJM, Bruins MJ, Frenken LGJ, Lombard CJ, Faber M. Effect of small-quantity lipid-based nutrient supplements on growth, psychomotor development, iron status, and morbidity among 6- to 12-mo-old infants in South Africa: a randomized controlled trial. Am J Clin Nutr. 2019 Jan 1;109(1):55-68. doi: 10.1093/ajcn/nqy282.

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2013
• Primary Completion (Actual): December 31, 2016
• Study Completion (Actual): December 31, 2016

Study Registration Dates

• First Submitted: November 30, 2012
• First Submitted That Met QC Criteria: April 30, 2013
• First Posted (Estimate): May 3, 2013

Study Record Updates

• Last Update Posted (Actual): November 30, 2017
• Last Update Submitted That Met QC Criteria: November 29, 2017
• Last Verified: November 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nutrition Disorders; Malnutrition; Physiological Effects of Drugs; Trace Elements; Micronutrients; Manganese
• Other Study ID Numbers: TSWAKA