The WinFood Intervention Study: the effects of improved complementary foods on nutrition and health among Cambodian infants and children

ISRCTN	ISRCTN19918531
DOI	https://doi.org/10.1186/ISRCTN19918531
Protocol serial number	N/A
Sponsor	University of Copenhagen (Denmark)
Funder	Danish Ministry of Foreign Affairs (Denmark) - Danish International Development Agency (Danida) (ref: 57-08-LIFE)

Submission date: 24/02/2011
Registration date: 25/03/2011
Last edited: 04/06/2015

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Nutritional, Metabolic, Endocrine

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Prof Henrik Friis
Scientific

Rolighedvej 30
Frederiksberg
1958
Denmark

Email	hfr@life.ku.dk

Study information

Primary study design	Interventional
Study design	Randomised single-blind study
Secondary study design	Randomised controlled trial
Study type	Participant information sheet
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
Study acronym	WinFood
Study objectives	Improved complementary foods based on locally available traditional ingredients will improve the nutritional and health status of Cambodian infants and children
Ethics approval(s)	National Ethics Committee for Health Research (NECHR), Cambodia, 22/10/2010, ref: Version No 1 dated 28-05-2010
Health condition(s) or problem(s) studied	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
Primary outcome measure(s)	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
Key secondary outcome measure(s)	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
Completion date	10/02/2012

Eligibility

Participant type(s)	Patient
Age group	Child
Lower age limit	6 Months
Sex	All
Target sample size at registration	440
Key inclusion criteria	Children who are 6 months old and have a weight-for-height z-score > -3
Key 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.
Date of first enrolment	07/03/2011
Date of final enrolment	10/02/2012

Locations

Countries of recruitment

Cambodia
Denmark

Study participating centre

Rolighedvej 30

Frederiksberg
1958
Denmark

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	01/01/2014		Yes	No
Results article	results	01/04/2015		Yes	No
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes