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Completed

NCT Number: NCT01845610

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

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.

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Key information

Age range

6 month–6 month

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Jouberton area of the greater Matlosana Municipality

Jouberton, North West, South Africa

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Dietary Supplement

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

Fortified fat-based paste with essential fatty acids

Dietary Supplement

Complementary food supplement fortified with micronutrients and essential fatty acids

Primary outcomes

  1. Linear growth by measuring length

    Time frame: 6 months

    To assess the effects of two different fortified fat-based complementary food supplements on linear growth compared to a control

Secondary outcomes

  1. 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

    To investigate the effects of two different fortified fat-based complementary food supplements on psycho-motor development of infants compared to a control group.

  2. Measures of anemia, essential fatty acid, iron and iodine status

    Time frame: 6 months

    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.

  3. 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

    To assess the effects of two different fortified fat-based complementary food supplements on weight, MUAC and head circumference of infants

Other outcomes

  1. Safety

    Time frame: 6 months

    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.

  2. Nutritional status of mothers/caregivers

    Time frame: 6 months

    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.

  3. Acceptability

    Time frame: 1 month

    Acceptability of complementary food supplements will be assessed before the start of the intervention trial

  4. Dietary assessment

    Time frame: 6 months

    Multiple pass 24-hr recall (baseline and end)

Sponsors and collaborators

Lead sponsor

North-West University, South Africa

Other

Collaborators

  • DSM Ltd
  • Global Alliance for Improved Nutrition
  • Unilever R&D

Registry information

Acronym: TSWAKA

Important dates

Study start
2013
Primary completion
2016
Study completion
2016
First posted
May 3, 2013
Registry last updated
Nov 30, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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