Acceptability, effectiveness and cost-effectiveness of soya maize sorghum-based ready-to-use therapeutic food in treating severe acute malnutrition in children under five in Lusaka, Zambia

ISRCTN	ISRCTN62376241
DOI	https://doi.org/10.1186/ISRCTN62376241
Protocol serial number	Irish Aid 07/01
Sponsor	Irish Aid (Ireland)
Funder	Valid Nutrition (UK)

Submission date: 29/05/2008
Registration date: 02/07/2008
Last edited: 02/07/2008

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Nutritional, Metabolic, Endocrine

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr Abel Hailu Irena
Scientific

Valid Nutrition
9026 Buluwe Road
Woodlands
Lusaka
N/A
Zambia

Phone	+260 1 261 375
Email	abel@validinternational.org

Study information

Primary study design	Interventional
Study design	Crossover design for acceptability, followed by a cluster randomised non-blind trial for the effectiveness study finished with a cost-effectiveness analysis
Secondary study design	Randomised controlled trial
Study type	Participant information sheet
Scientific title
Study objectives	1. The acceptability of soya maize sorghum ready-to-use therapeutic food (RUTF) among children is equivalent to that of peanut RUTF 2. The effectiveness of soya maize sorghum RUTF is equivalent to peanut RUTF in the treatment of severe acute malnutrition 3. Soya maize sorghum RUTF is less costly and therefore more cost-effective than peanut RUTF in the treatment of severe acute malnutrition
Ethics approval(s)	Ethics approval received from the University of Zambia, Biomedical Research Ethics Committee on the 6th May 2008 (Assurance no: FWA00000338 IRB00001131 of IORG0000774; ref: 10-04-08).
Health condition(s) or problem(s) studied	Severe acute malnutrition
Intervention	Total duration of treatment for the acceptability study is five weeks. Soya, maize and sorghum based RUTF will be compared to the control of peanut based RUTF. All admitted children in both arms will receive standard dose of medication as per Community-based Therapeutic Care protocol in use in Lusaka. In addition children in the intervention arm will be provided soya, maize and sorghum based RUTF tailored to weight (200 KCal/kg/Day) and children in the control arm will receive peanut based RUTF tailored to weight (200 KCal/kg/day). Both groups will receive the food until exit from the programme. From experience the average length of stay is 8 weeks and the maximum stay in the programme is 17 weeks, i.e. from time of recruitment until exit from the programme (either cured from severe acute malnutrition, or default, or death, or transfer, or non-cured). Those children who are discharged cured will be followed up at week 4, 6 months and 12 months.
Intervention type	Drug
Phase	Not Specified
Drug / device / biological / vaccine name(s)	Soya maize sorghum ready-to-use therapeutic food (RUTF), peanut RUTF
Primary outcome measure(s)	1. Acceptability study: RUTF acceptability, measured at end of five weeks. Data will be analysed to compare the acceptability of the RUTFs compared. 2. Randomised trial: recovery rate. Data for recovery rate will be measured routinely and analysed on monthly basis, however final analysis will be done at the end of the study period. 3. Cost effectiveness evaluation: 3.1. Incremental cost per death prevented, and per recovered child, measured at the end of the study period 3.2. Probability that the intervention is cost effective for different levels of willingness to pay per outcome (e.g. US$150/DALY gained), measured at the end of the study period
Key secondary outcome measure(s)	1. Acceptability study: 1.1. Dietary intake, measured daily during the five week period 1.2. Morbidity, measured daily for the whole duration 1.3. Weight gain, measured at entry, at the end of week 2, the beginning of week 4 and the end of week 5. In week three will be a wash out period. 2. Randomised trial: 2.1. Defaulter rate. Data for default rate will be collected and analysed routinely. However final comparison will be made at the end of the study. 2.2. Average weight gain from baseline (or, in oedematous children, from time of loss of oedema) until exit from the programme. Weight gain will be measured for each individual child and an average taken at the end. This will be done for children who successfully complete the treatment. 2.3. Morbidity (diarrhoea, vomiting, fever, cough). Incidence of morbidity will be compared between the two groups on regular basis (weekly) and at the end of the study. 2.4. Hospital referral. The number of children referred and outcome for referral will be measured and compared at the end of the study. 2.5. Mortality. Mortality data will be collected and analysed routinely. However final analysis will be made at the end of the study and comparison between the two arms will be made. 2.6. Length gain. Data on height will be captured at admission, week four, week eight and at discharge. 3. Cost effectiveness evaluation: cost of Community-based Therapeutic Care, including RUTF, measured at the end of study period
Completion date	03/08/2009

Eligibility

Participant type(s)	Patient
Age group	Child
Lower age limit	6 Months
Upper age limit	59 Months
Sex	All
Target sample size at registration	1654
Key inclusion criteria	1. Both male and female severely acutely malnourished children in the age range of 6 - 59 months 2. Mid-upper arm circumference less than 110 mm or oedema of + or ++ 3. Admitted into the Outpatient Therapeutic Programme at the health centre 4. Good appetite 5. No serious medical complication
Key exclusion criteria	There are no exclusion criteria to be used as all severely malnourished children with no complications need to be treated at the health centre level until recovery. However, severely malnourished children who do not have an appetite or have severe medical complications or marasmic-kwashiorkor will be first referred to the stabilisation centre (University Teaching Hospital) straight away. These children will be taken into the study once stabilised at the inpatient unit of University Teaching Hospital. They will receive the respective RUTF being used in the health centre then return to follow up treatment.
Date of first enrolment	16/06/2008
Date of final enrolment	03/08/2009

Locations

Countries of recruitment

Zambia

Study participating centre

Valid Nutrition

Lusaka
N/A
Zambia

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?
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes