Nutritional Treatment for the Amelioration of Traumatic Brain Injury (NUTRA-TBI)

Queen Mary University of London

Status: Active, not recruiting

Conditions: Traumatic Brain Injury

Treatments: Dietary Supplement: Souvenaid oral nutritional supplement (Nutricia)

Study type: Interventional

Funder types: Other

Identifiers

NCT04418440

273132

Details and patient eligibility

About

To test the feasibility of administering a commercially available neurotrophic oral nutritional supplement (ONS) for adult patients with acute traumatic brain injury at the Royal London Hospital.

Full description

The study will be a randomised controlled non-blinded trial of adult patients with acute traumatic brain injury at the Royal London Hospital.

There will be randomisation to one of two non-blinded trial groups:

Usual standard NHS care (control group) Usual standard NHS care plus daily oral dose of Souvenaid® ONS

The trial protocol will commence between 3-7 days after admission. The trial timeline provides a summary of intervention and assessments.

The trial will last 12 months. The first 6 months will be the formal trial with two groups and follow up assessments. This will be performed on intention to treat basis. After this initial phase the investigators will provide an opportunity for all participants from either group (control or treatment) to take Souvenaid® ONS for a further 6 months with a clinical follow up appointment.

Enrollment: 50 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Adult between 18 yrs and 80 yrs of age
• Acute traumatic brain injury with confirmed radiological features

Exclusion criteria

• Allergies to fish oil/milk/soya
• Medical history of galactosaemia
• Non-traumatic aetiology to head injury
• Unable to receive enteral nutrition
• Craniectomy during admission (loss of integrity of skull convexity)
• Concurrent active neurological disease
• Pregnancy or breastfeeding

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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50 participants in 2 patient groups

Control

No Intervention group

Description:

Routine NHS care following traumatic brain injury

Treatment

Experimental group

Description:

Routine NHS care following traumatic brain injury plus daily dose of test compound (oral nutritional supplement)

Treatment:

Dietary Supplement: Souvenaid oral nutritional supplement (Nutricia)