Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Abel Hailu Irena

ORCID ID

Contact details

Valid Nutrition
9026 Buluwe Road
Woodlands
Lusaka
N/A
Zambia
+260 1 261 375
abel@validinternational.org

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

Irish Aid 07/01

Study information

Scientific title

Acronym

Study hypothesis

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

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).

Study design

Crossover design for acceptability, followed by a cluster randomised non-blind trial for the effectiveness study finished with a cost-effectiveness analysis

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

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 names

Soya maize sorghum ready-to-use therapeutic food (RUTF), peanut RUTF

Primary outcome measures

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

Secondary outcome measures

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

Overall trial start date

16/06/2008

Overall trial end date

03/08/2009

Reason abandoned

Eligibility

Participant 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

Participant type

Patient

Age group

Child

Gender

Both

Target number of participants

Acceptability study: 50 children; effectiveness study: 1,604 children (total = 1654)

Participant 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.

Recruitment start date

16/06/2008

Recruitment end date

03/08/2009

Locations

Countries of recruitment

Zambia

Trial participating centre

Valid Nutrition
Lusaka
N/A
Zambia

Sponsor information

Organisation

Irish Aid (Ireland)

Sponsor details

Department of Foreign Affairs
Bishops Square
Redmond Hill
Dublin
2
Ireland
irishaid@dfa.ie

Sponsor type

Charity

Website

http://www.dci.gov.ie

Funders

Funder type

Charity

Funder name

Valid Nutrition (UK)

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

Publication citations

Editorial Notes