Randomized Controlled Trial in South Africa Comparing the Efficacy of Complementary Food Products on Child Growth
NCT ID: NCT01845610
Last Updated: 2017-11-30
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
750 participants
INTERVENTIONAL
2013-09-30
2016-12-31
Brief Summary
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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.
Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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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
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
Fortified fat-based paste with essential fatty acids
Complementary food supplement providing micronutrients and essential fatty acids (EFAs)
Fortified fat-based paste with essential fatty acids
Complementary food supplement fortified with micronutrients and essential fatty acids
Control group
The control group will receive a delayed intervention
No interventions assigned to this group
Interventions
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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
Fortified fat-based paste with essential fatty acids
Complementary food supplement fortified with micronutrients and essential fatty acids
Eligibility Criteria
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Inclusion Criteria
* Aged 6 months
Exclusion Criteria
* 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
6 Months
6 Months
ALL
Yes
Sponsors
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Global Alliance for Improved Nutrition
OTHER
DSM Ltd
INDUSTRY
Unilever R&D
INDUSTRY
North-West University, South Africa
OTHER
Responsible Party
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Marius Smuts
Professor
Principal Investigators
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Cornelius M Smuts, PhD
Role: PRINCIPAL_INVESTIGATOR
North-West University, South Africa
Locations
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Jouberton area of the greater Matlosana Municipality
Jouberton, North West, South Africa
Countries
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References
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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.
Other Identifiers
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TSWAKA
Identifier Type: -
Identifier Source: org_study_id