The Ready to Use Complementary Food (RUCF) Study
| ISRCTN | ISRCTN20267635 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN20267635 |
| Secondary identifying numbers | N/A |
- 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
Not provided at time of registration
Contact information
Dr Paluku Bahwere
Scientific
Scientific
Fond Tasnier 6
Genval
1332
Belgium
Study information
| Study design | Randomised controlled interventional trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Other |
| Study type | Quality of life |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient 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 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(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 |
| 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 |
| Primary outcome measure | 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 study start date | 15/11/2009 |
| Overall study end date | 30/12/2011 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Child |
| Sex | Both |
| Target number of participants | 677 infants per group (total: 1354 infants) |
| 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 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
- Belgium
- Congo, Democratic Republic
Study participating centre
Fond Tasnier 6
Genval
1332
Belgium
1332
Belgium
Sponsor information
Irish Aid (Ireland)
Charity
Charity
Department of Foreign Affairs
Bishops Square
Redmond Hill
Dublin
2
Ireland
| Website | http://www.dci.gov.ie |
|---|---|
"ROR" |
https://ror.org/03kyawa63 |
Funders
Funder type
Charity
Irish Aid (Ireland)
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | 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 |
