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

Malnutrition Clinical Trial

— TSWAKA  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01845610
• Other study ID #: TSWAKA
• Status: Completed
• Phase: N/A
• First received: November 30, 2012
• Last updated: November 29, 2017
• Start date: September 2013
• Est. completion date: December 31, 2016

Study information

• Verified date: November 2017
• Source: North-West University, South Africa
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 750
• Est. completion date: December 31, 2016
• Est. primary completion date: December 31, 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 6 Months to 6 Months

Eligibility

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

Related Conditions & MeSH terms

• Malnutrition

Intervention

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
• Fortified fat-based paste with essential fatty acids
Complementary food supplement fortified with micronutrients and essential fatty acids

Locations

Country	Name	City	State
South Africa	Jouberton area of the greater Matlosana Municipality	Jouberton	North-West

Sponsors (4)

Lead Sponsor	Collaborator
North-West University, South Africa	DSM Ltd, Global Alliance for Improved Nutrition, Unilever R&D

Country where clinical trial is conducted

South Africa, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Safety	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.	6 months
Other	Nutritional status of mothers/caregivers	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.	6 months
Other	Acceptability	Acceptability of complementary food supplements will be assessed before the start of the intervention trial	1 month
Other	Dietary assessment	Multiple pass 24-hr recall (baseline and end)	6 months
Primary	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	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
Secondary	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
Secondary	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