Micronutrient Supplement Effects on Cognitive Outcomes in Post-Acute TBI
Condition: Traumatic Brain Injury
MeSH terms: Brain Injuries; Brain Injuries, Traumatic
Study type: Interventional

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).
    

Detailed description: 
      Micronutrients (including vitamins, minerals and certain polyunsaturated fatty acids) are
      required by the brain for normal functioning and, with few exceptions, can only be obtained
      through dietary sources. Research into degenerative diseases of aging have linked
      mitochondrial aging and DNA damage caused by micronutrient deficiency to greater incidence of
      cognitive decline and stroke, among other diseases, in the general population, particularly
      in those consuming food rich in fats and carbohydrates but poor in micronutrient content.
      Other research focusing on cognition, behaviour and mood state has associated micronutrient
      deficiencies with a wide range of neurological conditions including Alzheimer's Disease,
      Parkinson's Disease, multiple sclerosis, autism spectrum disorders, depression, fatigue and
      schizophrenia. There have however been very few studies using micronutrient interventions in
      post-acute human TBI. In a study with thirty retired American Football players an
      intervention including supplementation with a broad-spectrum multivitamin, omega-3 fish oils
      and a number of other substances resulted in significant percentile score improvements in
      almost half of the participants (n=100) across a broad range of cognitive measures. Findings
      demonstrated that micronutrient intervention can result in significant measurable
      improvements in those with TBI many years following the initial insult. A normative study
      will be conducted with three groups assigned to Vit D, Vit C and multivitamin arms (N = 60)
      tested at baseline on cognitive function and post-intervention. The TBI study will recruit
      three groups of individuals with post-acute traumatic brain injuries and measure whether
      there is improved cognitive outcomes (measured by test-retest on a cognitive battery)
      associated with the supplements shown to be most effective in the pilot study.
    

Intervention name(s): Swisse Womens 50+ Ultivite Multivitamin; Holland and Barrett Triple Strength Omega-3 Fish Oil
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): Single tablet taken once daily; Single capsule taken once daily
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Supportive Care
Keywords: TBI