Reformulated F75 Milk to Treat Severe Acute Malnutrition

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 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.

Conditions

• Malnutrition
• Diarrhoea
• Metabolic Disturbance

Interventions

DIETARY_SUPPLEMENT

Standard F75 Milk

This is the standard F75 milk used worldwide (Control group)

DIETARY_SUPPLEMENT

Modified F75 Milk

This is the experimental group

Sponsors & Collaborators

• KEMRI-Wellcome Trust Collaborative Research Program

  collaborator OTHER

• Kamuzu University of Health Sciences

  collaborator OTHER

• The Hospital for Sick Children

  collaborator OTHER

• University of Groningen

  collaborator OTHER

• University of Oxford

  lead OTHER

Principal Investigators

• James A Berkley · KEMRI-Wellcome Trust Research Kilifi, Kenya

• Wieger Voskuijl · University of Medicine, Blantye Malawi

• Robert Bandsma, PhD · The Hospital for Sick Children, Toronto, Canada

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Model

PARALLEL

Eligibility

Min Age

6 Months

Max Age

13 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2014-12-31

Primary Completion

2015-12-31

Completion

2015-12-31

Countries

• Kenya
• Malawi

Study Locations