Status:
COMPLETED
Reformulated F75 Milk to Treat Severe Acute Malnutrition
Lead Sponsor:
University of Oxford
Collaborating Sponsors:
KEMRI-Wellcome Trust Collaborative Research Program
Kamuzu University of Health Sciences
Conditions:
Malnutrition
Diarrhoea
Eligibility:
All Genders
6-13 years
Phase:
PHASE2
PHASE3
Brief Summary
Inpatient treatment for complicated severe acute malnutrition (SAM) continues to have a high mortality in Africa. This is partly because children are commonly brought for admission because they are se...
Detailed Description
Admission to hospital with complicated severe acute malnutrition (SAM) in Africa commonly has a case fatality of 10-30%. Importantly, children are usually admitted to hospital because they are severel...
Eligibility Criteria
Inclusion
- Age 6 months to 13 years
- Severe malnutrition defined as: mid upper arm circumference (MUAC) \<11.5cm if less than 5 years old;19 or weight for height Z score \<-3; or kwashiorkor as defined in the current Kenyan and WHO guidelines.
- Admitted to hospital because of medical complications or failure of an appetite test as defined in the current WHO guidelines.
- Eligible to start F75 milk by current WHO guidelines.
Exclusion
- Declined to give informed consent.
- Known allergy to milk products.
- Any other reason the consenting investigator thinks that in the child's best interests it inappropriate for them to take part.
Key Trial Info
Start Date :
December 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2015
Estimated Enrollment :
842 Patients enrolled
Trial Details
Trial ID
NCT02246296
Start Date
December 1 2014
End Date
December 1 2015
Last Update
April 14 2016
Active Locations (3)
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1
Kilifi County Hospital
Kilifi, Coast, Kenya, 80108
2
Coast Provincial General Hospital - Study site
Mombasa, Kenya
3
Queen Elizabeth Hospital- Study site
Blantyre, Malawi