The Ready to Use Complementary Food (RUCF) Study

ISRCTN	ISRCTN20267635
DOI	https://doi.org/10.1186/ISRCTN20267635
Protocol serial number	N/A
Sponsor	Irish Aid (Ireland)
Funder	Irish Aid (Ireland)

Submission date: 08/11/2009
Registration date: 28/04/2010
Last edited: 19/06/2012

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Pregnancy and Childbirth

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr Paluku Bahwere
Scientific

Fond Tasnier 6
Genval
1332
Belgium

Study information

Primary study design	Interventional
Study design	Randomised controlled interventional trial
Secondary study design	Randomised controlled trial
Study type	Participant information sheet
Scientific title	The impact of high nutrient dense Ready to Use Complementary Food (RUCF) on growth of children below 2 years in South Kivu, Eastern Democratic Republic of Congo: a randomised controlled interventional trial
Study acronym	S-RUCF
Study objectives	This study will test the hypothesis that the use of a specially designed fortified spread (a specific Ready to Use Complementary Food [RUCF]) containing 500 kcal per 100 g as a complementary food for 12 months (from 6 months to 18 months of age) will reduce the incidence and prevalence of underweight and stunting.
Ethics approval(s)	1. Ethics Committee of the Free University of Brussels approved on the 10th March 2009 (ref: P2009/060/B40620095963) 2. Ethics Committee of the Centre de Recherche of Science Naturelles (CRSN) approved on the 28th September 2008
Health condition(s) or problem(s) studied	Underweight/stunting
Intervention	Intervention group: infants enrolled in the intervention group will receive 50 g of RUCF providing 250 kcal/day during 12 months (from the age of 6 to 18 months). The RUCF will be administered daily by the mother. Extension health workers serving the villages of participating children will visits the couples mother-infant biweekly. Control group: Infants enrolled in the control group will receive 1 kg of UNIMIX flour per week. The porridge offered to infant should provide 250 kcal/day.
Intervention type	Other
Primary outcome measure(s)	Prevalence of stunting at 12, 18 and 24 months of age.
Key secondary outcome measure(s)	1. Average daily breast milk intake at 6 and 9 months of age 2. Prevalence of exclusive breast feeding at 6 months of age 3. Mean change in anthropometric indices at 12, 18 and 24 months of age 4. Risks factors of stunting at 12 months of age 5. Incidence of diarrhoea at 12 months of age 6. Incidence of malaria at 12 months of age 7. Incidence of severe acute malnutrition at 12, 18 and 24 months of age 8. Proportion of children standing independently at 9 and 12 months of age 9. Proportion of children walking unassisted at 12 months of age 10. Mean cholesterol at 12 and 18 months of age 11. Mean triglycerides at 12 and 18 months of age 12. Mean haemoglobin at 12, 18 and 24 months of age
Completion date	30/12/2011

Eligibility

Participant type(s)	Patient
Age group	Child
Sex	All
Target sample size at registration	1354
Key inclusion criteria	1. Full term born infants (gestational age greater than 37 weeks and birth weight greater than 2500 g) 2. Consent given
Key exclusion criteria	1. Bottle-fed children 2. Children with any malformations or neurological impairment
Date of first enrolment	15/11/2009
Date of final enrolment	30/12/2011

Locations

Countries of recruitment

Belgium
Congo, Democratic Republic

Study participating centre

Fond Tasnier 6

Genval
1332
Belgium

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	01/05/2012		Yes	No
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes