Nutritional Treatment for the Amelioration of Traumatic Brain Injury
NCT ID: NCT04418440
Last Updated: 2024-11-29
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
32 participants
INTERVENTIONAL
2021-10-14
2024-04-30
Brief Summary
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Detailed Description
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There will be randomisation to one of two non-blinded trial groups:
1. Usual standard NHS care (control group)
2. 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.
Conditions
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Study Design
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RANDOMIZED
CROSSOVER
TREATMENT
NONE
Study Groups
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Control
Routine NHS care following traumatic brain injury
No interventions assigned to this group
Treatment
Routine NHS care following traumatic brain injury plus daily dose of test compound (oral nutritional supplement)
Souvenaid oral nutritional supplement (Nutricia)
Daily dose of a commercially available oral nutritional supplement based around the active compound recipe Fortasyn Connect, produced by Nutricia, Danone.
Interventions
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Souvenaid oral nutritional supplement (Nutricia)
Daily dose of a commercially available oral nutritional supplement based around the active compound recipe Fortasyn Connect, produced by Nutricia, Danone.
Eligibility Criteria
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Inclusion Criteria
* Acute traumatic brain injury with confirmed radiological features
Exclusion Criteria
* 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
18 Years
80 Years
ALL
No
Sponsors
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Queen Mary University of London
OTHER
Responsible Party
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Principal Investigators
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Chris Uff
Role: PRINCIPAL_INVESTIGATOR
Barts Health
Locations
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Bart Health, Royal London Hospital
London, , United Kingdom
Countries
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Other Identifiers
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273132
Identifier Type: -
Identifier Source: org_study_id