Micronutrient Supplement Effects on Cognitive Outcomes in Post-Acute TBI

Summary

Traumatic brain injury (TBI) refers to neuronal damage occurring as the result of an external force being applied to brain tissue. In the United Kingdom annual figures (2013-2014) show 449,000 hospital admittances with a diagnosis of head injury with males up to five times more likely to sustain a head injury than females. Traumatic brain injury (TBI) causes life-long disability, with no significant reduction in life expectancy, affecting a diverse range of cognitive and social functions including memory, task planning and execution, impulse control, social interactions, personality changes and depression. Following traumatic brain injury acquired deficits can lead to problems with resumption of aspects of daily life, particularly in terms of returning to work and interpersonal relationships.

The initial injury triggers a secondary cascade of metabolic, neurochemical and cellular changes within the brain, primarily aimed at limiting damage and stimulating repair. Paradoxically prolonged secondary cascade mechanisms, including haemorrhage, oedema, neuroinflammation and axonal injury, results in exacerbation of deficits observed. The heterogeneous on-going nature of the secondary cascade presents clinicians with opportunities to intervene in an attempt to limit neuronal damage. A large body of nutritional research has been focused on addressing the hypermetabolic and catabolic states created by secondary cascade processes in the acute stage. Addressing these demands has played a significant role in reducing mortality and infection rates following head injury, however there has not been the same depth of research investigating the post-acute period (once individuals are discharged from hospital).

Conditions

• Traumatic Brain Injury

Interventions

DIETARY_SUPPLEMENT

Swisse Womens 50+ Ultivite Multivitamin

Single tablet taken once daily

DIETARY_SUPPLEMENT

Holland and Barrett Triple Strength Omega-3 Fish Oil

Single capsule taken once daily

Sponsors & Collaborators

• Sheffield Teaching Hospitals NHS Foundation Trust

  collaborator OTHER

• Rotherham Doncaster and South Humber NHS Foundation Trust

  collaborator OTHER_GOV

• Sheffield Hallam University

  lead OTHER

Principal Investigators

• Lynne A Barker, PhD · Sheffield Hallam University

Study Design

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

DOUBLE

Model

CROSSOVER

Eligibility

Min Age

18 Years

Max Age

70 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2017-10-01

Primary Completion

2020-04-18

Completion

2020-04-18

Countries

• United Kingdom

Study Locations