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
Secondary identifying numbers 05CH03
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

Centre for International Child Health
Institute of Child Health
30 Guildford Street
London
WC1N 1EH
United Kingdom

Study information

Study designRandomised controlled trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Hospital
Study typeQuality of life
Scientific title
Study acronymPRONUT Study
Study objectivesIn 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) studiedSevere acute malnutrition
InterventionThe 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 typeOther
Primary outcome measureNutritional cure (%)
Secondary outcome measures1. Death rate (%)
2. Rate of weight gain (g/kg/day)
3. Incidence of illness episodes (including diarrhoea)
4. Length of stay in programme (days)
5. Default rate (%)
Overall study start date27/01/2006
Completion date27/04/2007

Eligibility

Participant type(s)Patient
Age groupChild
SexBoth
Target number of participantsInitially 1200, after simplification this was changed to 800. Recruitment completed.
Key inclusion criteriaAll 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 criteria1. Children with severe cerebral palsy or obvious dysmorphic syndrome
2. Children less than six months of age or 4 kg weight
Date of first enrolment27/01/2006
Date of final enrolment27/04/2007

Locations

Countries of recruitment

  • England
  • Malawi
  • United Kingdom

Study participating centre

Centre for International Child Health
London
WC1N 1EH
United Kingdom

Sponsor information

Institute of Child Health, University College London (UK)
University/education

30 Guildford Street
London
WC1N 1EH
England
United Kingdom

Phone + 44 (0)207 2429789
Email e.pendleton@ich.ucl.ac.uk
Website http://www.ucl.ac.uk
ROR logo "ROR" https://ror.org/02jx3x895

Funders

Funder type

Charity

At registration, prior to 23/07/09: Valid International (UK)

No information available

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)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot 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