Reformulated F75 Milk to Treat Severe Acute Malnutrition (F75)
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|ClinicalTrials.gov Identifier: NCT02246296|
Recruitment Status : Completed
First Posted : September 22, 2014
Last Update Posted : April 14, 2016
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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 seriously ill, rather than being brought to hospital because of malnutrition alone. Mortality rates are especially high where SAM is complicated by HIV or TB. The early phase of inpatient nutritional treatment for severe acute malnutrition is based on a low-protein milk known as F75, which is given to improve metabolic homeostasis prior to the re-feeding to achieve catch-up growth. F75 provides a high proportion of energy from carbohydrates, including sucrose, lactose and maltodextrin. However, malabsorption of different types of carbohydrates, but lactose in particular, is known to occur in SAM and may lead to osmotic diarrhoea. Diarrhoea is common in children with SAM and is associated with increased mortality. Furthermore, switching from a catabolic state to a high energy diet that consists of predominantly carbohydrates can lead to 're-feeding syndrome' that may lead to severe electrolyte abnormalities and multiple organ dysfunction.
The aim of this trial is to determine whether reducing the carbohydrate content of F75, and removing lactose, improves the stabilisation of severely malnourished children. The trial will involve randomising children who are eligible to receive F75 milk to either the current formulation or a revised formulation. Both formulations will be given according to current recommendations regarding frequency of feeding and caloric value. Since the purpose of F75 is to stabilise the child metabolically and biochemically, the primary endpoint of the trial will be time to stabilisation (the end of the first phase of treatment for severe acute malnutrition). Blood and stool samples at admission and after three days will be used to determine the effects on carbohydrate and fat malabsorption and evidence of the re-feeding syndrome. Children will be followed up until discharge from hospital. The project has been planned in consultation with the World Health Organisation (WHO) and, if the revised formulation of F75 results in improved outcomes, will lead to a global change in recommendations for its formulation.
|Condition or disease||Intervention/treatment||Phase|
|Malnutrition Diarrhoea Metabolic Disturbance||Dietary Supplement: Standard F75 Milk Dietary Supplement: Modified F75 Milk||Phase 2 Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||842 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||Randomized Controlled Trial of a Reduced Carbohydrate Formulation of F75 Therapeutic Milk Among Children With Severe Acute Malnutrition|
|Study Start Date :||December 2014|
|Actual Primary Completion Date :||December 2015|
|Actual Study Completion Date :||December 2015|
Active Comparator: Standard F75 Milk
F75 with 63% of total energy from carbohydrates, including 10% of energy from lactose (standard F75).
Dietary Supplement: Standard F75 Milk
This is the standard F75 milk used worldwide (Control group)
Other Name: Standard formulation F75 therapeutic milk
Experimental: Modified F75 Milk
F75 milk with 43% of total energy from carbohydrates, without any lactose, and providing the same amount of energy as standard F75 by increased lipid in the form of medium chain triglycerides.
Dietary Supplement: Modified F75 Milk
This is the experimental group
Other Name: Modified formulation F75 Milk
- Time to Stabilization [ Time Frame: During inpatient admission ]
The criteria for stabilisation will be according to WHO guidelines:
- Absence of any WHO danger or emergency signs: obstructed breathing, respiratory distress, cyanosis, shock (delayed capillary refill plus fast & weak pulse plus temperature gradient), severe anaemia (Hb<5g/dl), congestive cardiac failure, impaired consciousness, convulsions, severe dehydration, profuse watery diarrhoea, vomits everything, hypothermia.
If there is oedema at baseline, loss of oedema defined as improving from a severe +++ oedema (severe: generalized bilateral pitting oedema including feet, legs, arms and face) to ++ oedema (moderate: no upper arm or upper leg oedema and no facial oedema or from ++ oedema to + (mild: only feet/ankle oedema) or none; and
Tolerating full prescribed volume of F75 feeds and observed to be completing the feeds.
- 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 ]3 or more loose stools in the last 24 hours
- Number days requiring rehydration fluids [ Time Frame: Upto discharge from hospital, an expected average of 2 weeks ]Described as the number of days requiring Resomal or IV fluids
- Percentage change in weight to day 5 [ Time Frame: Up to day 5 of admission ]Percentage change in weight between admission and day 5
- Change in electrolyte serum electrolytes to day 3 [ Time Frame: Between baseline (admission) and day 3 ]Changes in sodium, potassium, magnesium, calcium, phosphate and albumin between admission and day 3
- Number of new onset severe clinical deterioration [ Time Frame: Upto discharge from hospital, an expected average of 2 weeks ]numbers of episodes of new onset severe clinical deterioration accompanied by one or more of the following features: shock (fast and weak pulse and limb versus core temperature gradient and capillary refill time>3 seconds), respiratory distress (subcostal chest wall indrawing, hypoxaemia (SaO2) or requiring oxygen); impaired consciousness (Blantyre coma score<4) or hypoglycaemia (<3.0 mmol/l);
- Mortality [ Time Frame: Upto discharge from hospital, an expected average of 2 weeks ]Mortality until discharge
- Time to discharge from hospital [ Time Frame: Time to discharge from hospital, an expected average of 2 weeks ]Time in days from admission to date of discharge
- Total days spent in stabilization phase [ Time Frame: During inpatient admission, an expected average of 2 weeks ]Total days spent in stabilization phase, including periods when the child may go back to the stabilization phase during deterioration
- Proportion of children with diarrhoeal pathogen detected [ Time Frame: During inpatient admission, an expected average of 2 weeks ]The proportion of children with a diarrheal pathogen detected and plasma and fecal bio makers of gut inflammation and permeability
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|Ages Eligible for Study:||6 Months to 13 Years (Child)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
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.
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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02246296
|Kilifi County Hospital|
|Kilifi, Coast, Kenya, 80108|
|Coast Provincial General Hospital - Study site|
|Queen Elizabeth Hospital- Study site|
|Principal Investigator:||James A Berkley||KEMRI-Wellcome Trust Research Kilifi, Kenya|
|Principal Investigator:||Wieger Voskuijl||University of Medicine, Blantye Malawi|
|Study Director:||Robert Bandsma, PhD||The Hospital for Sick Children, Toronto, Canada|
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
|Responsible Party:||University of Oxford|
|Other Study ID Numbers:||
P.03/14/1540 ( Other Identifier: COMREC Blantyre Malawi )
SSC 2799 ( Other Identifier: KEMRI ERC Kenya )
|First Posted:||September 22, 2014 Key Record Dates|
|Last Update Posted:||April 14, 2016|
|Last Verified:||April 2016|
severe acute malnutrition
Severe Acute Malnutrition
Signs and Symptoms, Digestive