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

Study Overview
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Brief Summary
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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.

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

Conditions
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Malnutrition

Intervention / Treatment
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* 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


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 6 Months
Maximum Age: 6 Months

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Fortified fat-based paste with EFAs, DHA, ARA and phytase<br>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<br>* Complementary food supplement providing micronutrients, essential fatty acids, DHA and ARA, phytase, L-lysine, potassium, phosphorous, magnesium and manganese<br>|
| Experimental: Fortified fat-based paste with essential fatty acids<br>Complementary food supplement providing micronutrients and essential fatty acids (EFAs) | Dietary Supplement: Fortified fat-based paste with essential fatty acids<br>* Complementary food supplement fortified with micronutrients and essential fatty acids<br>|
| No Intervention: Control group<br>The control group will receive a delayed intervention | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Psychomotor-motor development measured by the Kilifi Developmental Inventory and Parent rating (gross motor skills) at baseline and end. Motor milestones chart (weekly) | To investigate the effects of two different fortified fat-based complementary food supplements on psycho-motor development of infants compared to a control group. | 6 months | 
| Measures of anemia, essential fatty acid, iron and iodine status | 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. | 6 months | 
| Growth by measuring weight of infant (bi-monthly, mid-upper arm circumference (MUAC) and head circumference of infant (baseline and end) | To assess the effects of two different fortified fat-based complementary food supplements on weight, MUAC and head circumference of infants | 6 month |