Condition category
Pregnancy and Childbirth
Date applied
08/11/2009
Date assigned
28/04/2010
Last edited
19/06/2012
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

Dr Paluku Bahwere

ORCID ID

Contact details

Fond Tasnier 6
Genval
1332
Belgium

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

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

Acronym

S-RUCF

Study hypothesis

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

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

Study design

Randomised controlled interventional trial

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

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

Phase

Not Applicable

Drug names

Primary outcome measures

Prevalence of stunting at 12, 18 and 24 months of age.

Secondary outcome measures

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

Overall trial start date

15/11/2009

Overall trial end date

30/12/2011

Reason abandoned

Eligibility

Participant inclusion criteria

1. Full term born infants (gestational age greater than 37 weeks and birth weight greater than 2500 g)
2. Consent given

Participant type

Patient

Age group

Child

Gender

Both

Target number of participants

677 infants per group (total: 1354 infants)

Participant exclusion criteria

1. Bottle-fed children
2. Children with any malformations or neurological impairment

Recruitment start date

15/11/2009

Recruitment end date

30/12/2011

Locations

Countries of recruitment

Congo, Democratic Republic

Trial participating centre

Fond Tasnier 6
Genval
1332
Belgium

Sponsor information

Organisation

Irish Aid (Ireland)

Sponsor details

Department of Foreign Affairs
Bishops Square
Redmond Hill
Dublin
2
Ireland

Sponsor type

Charity

Website

http://www.dci.gov.ie

Funders

Funder type

Charity

Funder name

Irish Aid (Ireland)

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

1. 2012 results in http://www.ncbi.nlm.nih.gov/pubmed/22492382

Publication citations

  1. Results

    Bisimwa G, Owino VO, Bahwere P, Dramaix M, Donnen P, Dibari F, Collins S, Randomized controlled trial of the effectiveness of a soybean-maize-sorghum-based ready-to-use complementary food paste on infant growth in South Kivu, Democratic Republic of Congo., Am. J. Clin. Nutr., 2012, 95, 5, 1157-1164, doi: 10.3945/ajcn.111.028704.

Additional files

Editorial Notes