A randomised controlled trial to compare the efficacy of three new formulations of Ready-to-Use Therapeutic Food (RUTF) in the treatment of severe acute childhood malnutrition
| ISRCTN | ISRCTN19364765 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN19364765 |
| Protocol serial number | 05CH03 |
| Sponsor | Institute of Child Health, University College London (UK) |
| Funders | At registration, prior to 23/07/09: Valid International (UK), Corrected on 23/07/09: the project was funded from a core grant from the Department for International Development (DFID) (UK) to Concern Worldwide (Ireland) |
- Submission date
- 16/12/2005
- Registration date
- 23/01/2006
- Last edited
- 23/07/2009
- 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
Dr Andrew Seal
Scientific
Scientific
Centre for International Child Health
Institute of Child Health
30 Guildford Street
London
WC1N 1EH
United Kingdom
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Randomised controlled trial |
| Secondary study design | Randomised controlled trial |
| Scientific title | |
| Study acronym | PRONUT Study |
| Study objectives | In a population of severely malnourished children: 1. Low-milk/chickpea-based RUTF (Ready-to-Use Therapeutic Food) is non-inferior (one-sided equivalence hypothesis) to high-milk/peanut-based RUTF. 2. Probiotic/Prebiotic enhanced ('Synbiotic 2000 Forte') RUTF is superior to standard RUTF. Due to a delay in the food acceptability pilot studies, the trial was simplified to test only the second hypothesis: Probiotic/Prebiotic enhanced ('synbiotic 2000 Forte') RUTF is superior to standard RUTF. |
| Ethics approval(s) | College of Medicine Research and Ethics Committee, Malawi (COMREC) (reference number: P03/04/236). Final approval, including amendments: 10th November 2005. Simplification of study to test only second hypothesis approved April 2006. |
| Health condition(s) or problem(s) studied | Severe acute malnutrition |
| Intervention | The initial plan was that after initial in-patient stabilisation with F75 milk, enrolled children would be randomised to one of four different types of RUTF: 1. (Control) Standard, high-milk/peanut based RUTF 2. Standard RUTF with added synbiotic 3. New formulation low-milk/chickpea-based RUTF 4. New formulation RUTF with added synbiotic Due to delays in the food acceptability pilot studies, the trial was simplified prior to start, and as of beginning of enrolment in July 2006 is testing only: 1. (Control) Standard, high-milk/peanut based RUTF 2. Standard RUTF with added synbiotic The simplified study started enrolling patients on 12th July 2006, and is expected to end in April 2007. |
| Intervention type | Other |
| Primary outcome measure(s) |
Nutritional cure (%) |
| Key secondary outcome measure(s) |
1. Death rate (%) |
| Completion date | 27/04/2007 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Child |
| Sex | All |
| Target sample size at registration | 800 |
| Key inclusion criteria | All children suffering from severe acute malnutrition (World Health Organisation [WHO] criteria: less than 70% weight/height and/or oedema) admitted to Moyo Malnutrition Ward, Queen Elizabeth Hospital, Blantyre, Malawi |
| Key exclusion criteria | 1. Children with severe cerebral palsy or obvious dysmorphic syndrome 2. Children less than six months of age or 4 kg weight |
| Date of first enrolment | 27/01/2006 |
| Date of final enrolment | 27/04/2007 |
Locations
Countries of recruitment
- United Kingdom
- England
- Malawi
Study participating centre
Centre for International Child Health
London
WC1N 1EH
United Kingdom
WC1N 1EH
United Kingdom
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 | 11/07/2009 | Yes | No |
