Condition category
Nutritional, Metabolic, Endocrine
Date applied
24/02/2011
Date assigned
25/03/2011
Last edited
04/06/2015
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Prof Henrik Friis

ORCID ID

Contact details

Rolighedvej 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: the effects of improved complementary foods on nutrition and health among Cambodian infants and children, a randomised, single-blind study

Acronym

WinFood

Study hypothesis

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

Ethics approval

National Ethics Committee for Health Research (NECHR), Cambodia, 22/10/2010, ref: Version No 1 dated 28-05-2010

Study design

Randomised single-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

Four 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: rice and two highly-nutritious fish and one spider species
2. WinFood Light: rice and a common fish species plus vitamin-mineral premix
3. Corn-Soy-Blend Plus (CSB+)
4. Corn-Soy-Blend Plus Plus (CSB++).
Food class (1 & 2) are the experimental and food class (3 & 4) are the control interventions

Intervention type

Other

Phase

Not Applicable

Drug names

Primary outcome measures

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

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

Overall trial start date

07/03/2011

Overall trial end date

10/02/2012

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

Child

Gender

Both

Target number of participants

440

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

07/03/2011

Recruitment end date

10/02/2012

Locations

Countries of recruitment

Cambodia

Trial participating centre

Rolighedvej 30
Frederiksberg
1958
Denmark

Sponsor information

Organisation

University of Copenhagen (Denmark)

Sponsor details

Department of Human Nutrition
Rolighedsvej 30
Frederiksberg
1958
Denmark
-
hfr@life.ku.dk

Sponsor type

University/education

Website

Funders

Funder type

Government

Funder name

Danish Ministry of Foreign Affairs (Denmark) - Danish International Development Agency (Danida) (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

2014 results in: http://www.ncbi.nlm.nih.gov/pubmed/24153341
2015 results in: http://www.ncbi.nlm.nih.gov/pubmed/25833972

Publication citations

  1. Results

    Skau JK, Bunthang T, Chamnan C, Wieringa FT, Dijkhuizen MA, Roos N, Ferguson EL, The use of linear programming to determine whether a formulated complementary food product can ensure adequate nutrients for 6- to 11-month-old Cambodian infants., Am. J. Clin. Nutr., 2014, 99, 1, 130-138, doi: 10.3945/ajcn.113.073700.

  2. Results

    Skau JK, Touch B, Chhoun C, Chea M, Unni US, Makurat J, Filteau S, Wieringa FT, Dijkhuizen MA, Ritz C, Wells JC, Berger J, Friis H, Michaelsen KF, Roos N, Effects of animal source food and micronutrient fortification in complementary food products on body composition, iron status, and linear growth: a randomized trial in Cambodia., Am J Clin Nutr, 2015 , 101, 4, 742-751, doi: 10.3945/ajcn.114.084889.

Additional files

Editorial Notes