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

NCT01845610 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 750

Last updated 2017-11-30

No results posted yet for this study

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.

Conditions

  • Malnutrition

Interventions

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

DIETARY_SUPPLEMENT

Fortified fat-based paste with essential fatty acids

Complementary food supplement fortified with micronutrients and essential fatty acids

Sponsors & Collaborators

  • Global Alliance for Improved Nutrition

    collaborator OTHER

  • DSM Ltd

    collaborator INDUSTRY

  • Unilever R&D

    collaborator INDUSTRY

  • North-West University, South Africa

    lead OTHER

Principal Investigators

  • Cornelius M Smuts, PhD · North-West University, South Africa

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
6 Months
Max Age
6 Months
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2013-09-30
Primary Completion
2016-12-31
Completion
2016-12-31

Countries

  • South Africa

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01845610 on ClinicalTrials.gov