Malnutrition Clinical Trial
— MODMALOfficial title:
Randomized Controlled Trial of an Outpatient Strategy of Ready to Use Supplementary Food (RUSF) Among Moderately Malnourished Children With Acute Infection
Verified date | June 2013 |
Source | University of Oxford |
Contact | n/a |
Is FDA regulated | No |
Health authority | Kenya: Ethical Review Committee |
Study type | Interventional |
The purpose of this study is to determine whether an outpatient-based strategy of short-term, ready to use supplementary food (RUSF) among moderately malnourished children with acute infections achieves greater improvement in anthropometric measurements of wasting than usual diet.
Status | Terminated |
Enrollment | 64 |
Est. completion date | November 2009 |
Est. primary completion date | October 2009 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 6 Months to 5 Years |
Eligibility |
Inclusion Criteria: - Age 6 months to 5 years - Mid-upper arm circumference (MUAC) less than 12.5 cm - Resident in the Kilifi demographic surveillance (DSS) area - Presentation with acute (<5 days) illness including respiratory infection, malaria, diarrhoeal disease or other acute infection. - If admitted, admission of <5 days, recruited at discharge. Exclusion Criteria: - Severe malnutrition (WHZ score < -3 or Kwashiorkor) - Requiring admission to hospital in the opinion of clinician - Known allergy to maize, soya, sorghum, milk or any RUSF components. - Consent declined - Underlying condition precluding assessment or inclusion - Any other reason why the consenting investigator thinks it is not appropriate for them to take part. |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Kenya | Kemri Wellcome Trust Research Programme | Kilifi | Coast Province |
Kenya | Kilifi District Hospital- OPD | Kilifi | Coast |
Lead Sponsor | Collaborator |
---|---|
University of Oxford |
Kenya,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Weight for Height z Score at 4 Weeks | The primary endpoint is weight for height z scores (WHZ), calculated from weight and height measures with reference to the WHO growth standards 2006. WHZ is a measure of wasting and acute malnutrition. A WHZ of zero is the median value of the reference population. Negative scores indicate undernutrition. Moderate and severe acute malnutrition are defined as WHZ<-2 and <-3 respectively. These correspond to 2 and 3 standard deviations below the reference median. Of all the anthropometric measures in regular use, WHZ and mid upper arm circumference (MUAC) have the strongest associations with infectious disease incidence and risk of death. WHZ is more appropriate than Weight for Age (WAZ), which is normally used in growth monitoring, because WAZ measures a combination of wasting and stunting (chronic malnutrition). Stunting is unlikely to be affected by short term intervention. WHZ is assessed by anthropometry, following WHO guidelines. |
between enrolment and 4 weeks | No |
Secondary | WHZ Score at 3 Months | between enrolment and 3 months | No | |
Secondary | MUAC for Age Z Score at 3 Months | between enrolment and 4 weeks and at 3 months | No | |
Secondary | Development of Severe Malnutrition (WHZ Score <-3 and/or Kwashiorkor) | at 4 weeks and 3 months | No | |
Secondary | Anemia (Hb <9.3g/dl) | at 4 weeks | No | |
Secondary | Hospital Admission or Death | from enrolment to 3 months | No |
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