Condition category
Nutritional, Metabolic, Endocrine
Date applied
30/03/2012
Date assigned
11/05/2012
Last edited
11/05/2012
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims:
The World Health Organization recommends that infants be exclusively breastfed with no other food or liquid given until the age of 6 months. At 6 months, other foods need to be introduced to complement breast milk. In developing countries, including Kenya, such foods introduced at the age of 6 months or earlier mainly comprise thin porridges made exclusively from plant based foodstuffs. It is likely that the sharp growth faltering observed from 6 months onto 2 years and beyond is associated with consumption of foods that provide inadequate energy and sub-optimal amounts of essential nutrients such as iron and zinc. The Winfood Project is a collaboration between University of Copenhagen and University of Nairobi aiming to improve the quality of complementary foods fed to infants and young children in Kenya so as to improve growth and health via utilisation of often neglected traditional foodstuffs such as small fish, edible insects and grains and processing them in a way that nutrient and energy density is enhanced.
The trial aims to test the effect of three foods:
Winfood Classic – with maize, grain amaranth, edible termites and fish
Winfood Lite – maize, grain amaranth and premix of vitamins and minerals
Corn soy blend plus (CSB+) with mineral and vitamin premix
The effect on growth, lean and body fat composition, gross psychomotor milestones, zinc and iron status of Kenyan infants and young children supplemented for 9 months from 6-15 months of age will be measured.

Who can participate?
Normal infants living in rural Western Kenya - all non-malnourished, non-severely anaemic 6-month old infants. In total 500 infants will take part for 9 months.

What does the study involve?
Six-month old infants are randomly allocated to one of the three study foods, listed above. In order to monitor growth, weight, length, head circumference, and mid upper arm circumferences are measured monthly. Haemoglobin, is measured by finger prick and venous blood is drawn to measure iron and zinc status at 6 months and 15 months of age. In order to determine lean mass and body fat composition in the infants, saliva samples are drawn and analysed.

What are the possible benefits and risks of participating?
The benefits include receiving food rations for 9 months. Additionally, we expect improved growth and health among infants receiving food supplementation. There may be discomfort to children due to pain during drawing of blood. Otherwise there are no direct risks that may be associated with this study.

Where is the study run from?
This study is based in three rural health centres in Mumias District, Western Province, Kenya.

When is study starting and how long is it expected to run for?
The study commenced in January 2012 and is expected to run until January 2013.

Who is funding the study?
Danish International Development Agency (DANIDA)

Who is the main contact?
Prof Henrik Friis
hfr@life.ku.dk 

Trial website

Contact information

Type

Scientific

Primary contact

Prof Henrik Friis

ORCID ID

Contact details

University of Copenhagen
Rolighedsvej 30
Frederiksberg
1958
Denmark
hfr@life.ku.dk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

The WinFood Intervention Study: randomised controlled trial of the effect of improved complementary foods on infant growth, body composition and gross motor development in Western Kenya

Acronym

WinFood

Study hypothesis

Improved complementary foods based on locally available traditional ingredients will improve the nutritional and health status of Kenyan infants

Ethics approval

Kenyatta National Hospital and University of Nairobi Ethics Committee, Kenya 07 April 2011

Study design

Randomised double-blind study

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Other

Trial type

Quality of life

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Infants at risk of undernutrition

Intervention

Three different pre-cooked complementary food supplements given as a porridge daily from 6-15 months of age (6-8 months: 50 g, 9-12 months: 75 g, 13-15 months: 125 g)
1. WinFood CF: amaranth grain, maize and one highly-nutritious fish and one edible termite species
2. WinFood Light: amaranth grain, maize plus vitamin-mineral premix
3. Corn-Soy-Blend Plus (CSB+)

Food class (1 & 2) are the experimental and food class (3) is the control intervention

Intervention type

Other

Phase

Not Applicable

Drug names

Primary outcome measures

Changes in linear growth (stunting), fat-free body mass (deuterium dilution), iron status (serum ferritin and transferrin receptors) from baseline (age 6 months) until the end of the 9 month intervention

Secondary outcome measures

Changes in:
1. Physical activity (using an accelerometer, actigraph)
2. Motor milestones (questionnaire, clinic visits)
3. Morbidity
4. Haemoglobin concentration (using Haemocue)
5. Serum concentrations of acute phase proteins [C-reactive protein (CRP) and a-acid glycoprotein(AGP)], insulin-like growth factor (IGF)-1 and zinc
6. Whole blood fatty acid composition

Measured from baseline (age 6 months) until the end of the 9 month intervention

Overall trial start date

15/01/2012

Overall trial end date

30/12/2012

Reason abandoned

Eligibility

Participant inclusion criteria

Children who are 6 months old and have a weight-for-height z-score > -3

Participant type

Patient

Age group

Neonate

Gender

Both

Target number of participants

450

Participant exclusion criteria

1. Weight-for-height z-score < -3
2. Bilateral pitting oedema
3. Haemoglobin (Hb) < 80 g/L
4. Clinical signs of vitamin A deficiency (xerosis or Bitot spots). These children will be referred for treatment

Recruitment start date

15/01/2012

Recruitment end date

30/12/2012

Locations

Countries of recruitment

Kenya

Trial participating centre

University of Copenhagen
Frederiksberg
1958
Denmark

Sponsor information

Organisation

University of Copenhagen (Denmark)

Sponsor details

Rolighedsvej 30
Frederiksberg
1958
Denmark

Sponsor type

University/education

Website

http://www.ku.dk/english/

Funders

Funder type

Government

Funder name

Danish Ministry of Foreign Affairs - Danish International Development Agency (Denmark) ref: 57-08-LIFE

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes