Randomized Controlled Trial in South Africa Comparing the Efficacy of Complementary Food Products on Child Growth
TSWAKA
1 other identifier
interventional
750
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Sep 2013
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 30, 2012
CompletedFirst Posted
Study publicly available on registry
May 3, 2013
CompletedStudy Start
First participant enrolled
September 1, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
December 31, 2016
CompletedNovember 30, 2017
November 1, 2017
3.3 years
November 30, 2012
November 29, 2017
Conditions
Outcome Measures
Primary Outcomes (1)
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 Outcomes (3)
Psychomotor-motor development measured by the Kilifi Developmental Inventory and Parent rating (gross motor skills) at baseline and end. Motor milestones chart (weekly)
6 months
Measures of anemia, essential fatty acid, iron and iodine status
6 months
Growth by measuring weight of infant (bi-monthly, mid-upper arm circumference (MUAC) and head circumference of infant (baseline and end)
6 month
Other Outcomes (4)
Safety
6 months
Nutritional status of mothers/caregivers
6 months
Acceptability
1 month
- +1 more other outcomes
Study Arms (3)
Fortified fat-based paste with EFAs, DHA, ARA and phytase
EXPERIMENTALComplementary 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
EXPERIMENTALComplementary food supplement providing micronutrients and essential fatty acids (EFAs)
Control group
NO INTERVENTIONThe control group will receive a delayed intervention
Interventions
Complementary food supplement providing micronutrients, essential fatty acids, DHA and ARA, phytase, L-lysine, potassium, phosphorous, magnesium and manganese
Complementary food supplement fortified with micronutrients and essential fatty acids
Eligibility Criteria
You may qualify if:
- Infants resident in the study area
- Aged 6 months
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- North-West University, South Africalead
- Global Alliance for Improved Nutritioncollaborator
- DSM Ltdcollaborator
- Unilever R&Dcollaborator
Study Sites (1)
Jouberton area of the greater Matlosana Municipality
Jouberton, North West, South Africa
Related Publications (1)
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.
PMID: 30649163DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Cornelius M Smuts, PhD
North-West University, South Africa
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
November 30, 2012
First Posted
May 3, 2013
Study Start
September 1, 2013
Primary Completion
December 31, 2016
Study Completion
December 31, 2016
Last Updated
November 30, 2017
Record last verified: 2017-11