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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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25 April 2016 |
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Main ID: |
NCT02246296 |
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Date of registration:
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10/09/2014 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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Reformulated F75 Milk to Treat Severe Acute Malnutrition
F75 |
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Scientific title:
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Randomized Controlled Trial of a Reduced Carbohydrate Formulation of F75 Therapeutic Milk Among Children With Severe Acute Malnutrition |
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Date of first enrolment:
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December 2014 |
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Target sample size:
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842 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT02246296 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
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Phase:
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Phase 2/Phase 3
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Countries of recruitment
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Kenya
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Malawi
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Contacts
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Name:
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James A Berkley |
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Address:
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Telephone:
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Email:
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Affiliation:
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KEMRI-Wellcome Trust Research Kilifi, Kenya |
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Name:
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Wieger Voskuijl |
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Address:
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Telephone:
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Email:
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Affiliation:
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University of Medicine, Blantye Malawi |
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Name:
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Robert Bandsma, PhD |
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Address:
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Telephone:
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Email:
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Affiliation:
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The Hospital for Sick Children, Toronto, Canada |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
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 Criteria:
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.
Age minimum:
6 Months
Age maximum:
13 Years
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Diarrhoea
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Malnutrition
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Metabolic Disturbance
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Intervention(s)
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Dietary Supplement: Modified F75 Milk
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Dietary Supplement: Standard F75 Milk
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Primary Outcome(s)
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Time to Stabilization
[Time Frame: During inpatient admission]
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Secondary Outcome(s)
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Number days requiring rehydration fluids
[Time Frame: Upto discharge from hospital, an expected average of 2 weeks]
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Mortality
[Time Frame: Upto discharge from hospital, an expected average of 2 weeks]
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Percentage change in weight to day 5
[Time Frame: Up to day 5 of admission]
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Proportion of children with diarrhoeal pathogen detected
[Time Frame: During inpatient admission, an expected average of 2 weeks]
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Number days with diarrhoea
[Time Frame: Upto discharge from hospital participants will be followed for the duration of hospital stay, an expected average of 2 weeks]
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Number of new onset severe clinical deterioration
[Time Frame: Upto discharge from hospital, an expected average of 2 weeks]
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Change in electrolyte serum electrolytes to day 3
[Time Frame: Between baseline (admission) and day 3]
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Total days spent in stabilization phase
[Time Frame: During inpatient admission, an expected average of 2 weeks]
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Time to discharge from hospital
[Time Frame: Time to discharge from hospital, an expected average of 2 weeks]
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Secondary ID(s)
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OXTREC 58-14
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P.03/14/1540
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SSC 2799
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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