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

This study is currently recruiting participants. (see Contacts and Locations)
Verified May 2014 by North-West University, South Africa
Sponsor:
Collaborators:
Global Alliance for Improved Nutrition
DSM Ltd
Unilever R&D
Information provided by (Responsible Party):
Marius Smuts, North-West University, South Africa
ClinicalTrials.gov Identifier:
NCT01845610
First received: November 30, 2012
Last updated: May 5, 2014
Last verified: May 2014
  Purpose

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.


Condition Intervention Phase
Malnutrition
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
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Randomized Controlled Trial in South Africa Comparing the Efficacy of Complementary Food Products on Child Growth

Resource links provided by NLM:


Further study details as provided by North-West University, South Africa:

Primary Outcome Measures:
  • Linear growth by measuring length [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    To assess the effects of two different fortified fat-based complementary food supplements on linear growth compared to a control


Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
    To investigate the effects of two different fortified fat-based complementary food supplements on psycho-motor development of infants compared to a control group.

  • Measures of anemia, essential fatty acid, iron and iodine status [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
    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.

  • 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 ] [ Designated as safety issue: No ]
    To assess the effects of two different fortified fat-based complementary food supplements on weight, MUAC and head circumference of infants


Other Outcome Measures:
  • Safety [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
    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.

  • Nutritional status of mothers/caregivers [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    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.

  • Acceptability [ Time Frame: 1 month ] [ Designated as safety issue: Yes ]
    Acceptability of complementary food supplements will be assessed before the start of the intervention trial

  • Dietary assessment [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    Multiple pass 24-hr recall (baseline and end)


Estimated Enrollment: 750
Study Start Date: September 2013
Estimated Study Completion Date: December 2015
Estimated Primary Completion Date: March 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   6 Months to 6 Months
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01845610

Contacts
Contact: Cornelius M Smuts, PhD 0027182992086 marius.smuts@nwu.ac.za

Locations
South Africa
Jouberton area of the greater Matlosana Municipality Recruiting
Jouberton, North-West, South Africa
Contact: Cornelius M Smuts, PhD    +27182992086    marius.smuts@nwu.ac.za   
Principal Investigator: Cornelius M Smuts, PhD         
Principal Investigator: Mieke Faber, PhD         
Sub-Investigator: Namukolo Covic, PhD         
Sub-Investigator: Grieta Hanekom, PhD         
Sub-Investigator: Johann Jerling, PhD         
Sub-Investigator: Salome Kruger, PhD         
Sub-Investigator: Jane Kvalsvig, PhD         
Sub-Investigator: Averalda van Graan, PhD         
Sub-Investigator: Carl Lombard, PhD         
Sponsors and Collaborators
North-West University, South Africa
Global Alliance for Improved Nutrition
DSM Ltd
Unilever R&D
Investigators
Principal Investigator: Cornelius M Smuts, PhD North-West University, South Africa
  More Information

No publications provided

Responsible Party: Marius Smuts, Professor, North-West University, South Africa
ClinicalTrials.gov Identifier: NCT01845610     History of Changes
Other Study ID Numbers: TSWAKA
Study First Received: November 30, 2012
Last Updated: May 5, 2014
Health Authority: South Africa: National Health Research Ethics Council

Additional relevant MeSH terms:
Malnutrition
Nutrition Disorders
Manganese
Micronutrients
Trace Elements
Growth Substances
Pharmacologic Actions
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on October 21, 2014