Clinical trial NCT01845610: Randomized Controlled Trial in South Africa Comparing the Efficacy of Complementary Food Products on Child Growth
Official title: Randomized Controlled Trial in South Africa Comparing the Efficacy of Complementary Food Products on Child Growth
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Malnutrition
Lead sponsor: North-West University, South Africa
Sponsor class: OTHER
Collaborators: name: Global Alliance for Improved Nutrition
name: DSM Ltd
name: Unilever R&D
First posted: 2013-05-03
Enrollment: 750
Sex: ALL
Minimum age (years): 6
Maximum age (years): 6
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility 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

Primary outcomes:
measure: Linear growth by measuring length
timeFrame: 6 months
Secondary outcomes:
measure: Psychomotor-motor development measured by the Kilifi Developmental Inventory and Parent rating (gross motor skills) at baseline and end. Motor milestones chart (weekly)
timeFrame: 6 months
measure: Measures of anemia, essential fatty acid, iron and iodine status
timeFrame: 6 months
measure: Growth by measuring weight of infant (bi-monthly, mid-upper arm circumference (MUAC) and head circumference of infant (baseline and end)
timeFrame: 6 month
Other outcomes:
measure: Safety
timeFrame: 6 months
measure: Nutritional status of mothers/caregivers
timeFrame: 6 months
measure: Acceptability
timeFrame: 1 month
measure: Dietary assessment
timeFrame: 6 months
Locations:
city: Jouberton
country: South Africa
facility: Jouberton area of the greater Matlosana Municipality
state: North-West
Study officials:
affiliation: North-West University, South Africa
name: Cornelius M Smuts, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.