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NCT Number: NCT03032302

Micronutrient Supplement Effects on Cognitive Outcomes in Post-Acute TBI

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).

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Key information

Conditions

Traumatic Brain Injury Brain Diseases Brain Injuries Brain Injuries, Traumatic Central Nervous System Diseases Craniocerebral Trauma Nervous System Diseases Trauma, Nervous System Wounds and Injuries

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Sheffield Hallam University

Sheffield, South Yorkshire, S10 2BQ, United Kingdom

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • First and only traumatic brain injury.
  • Complex mild to moderate injury.
  • 3-24 months post-injury

Exclusion criteria

  • Unable to give informed consent.
  • Already taking micronutrient/fatty acid supplements.
  • Hemianopia
  • Hemiplegia.
  • Pregnant or breastfeeding.
  • Diagnosed with clinically low blood pressure, diabetes, or disease of neurodegeneration.

Treatment and study plan

Swisse Womens 50+ Ultivite Multivitamin

Dietary Supplement

Single tablet taken once daily

Holland and Barrett Triple Strength Omega-3 Fish Oil

Dietary Supplement

Single capsule taken once daily

Primary outcomes

  1. Performance on cognitive test measures (a battery of standardized tests; memory, executive function, social cognition, general intelligence, learning and processing speed)

    Time frame: Three time points: baseline (T1), 8 weeks (T2) and 22 weeks (T3)

    Analysis of change in cognitive test battery results between each time point (T2 minus T1. T3 minus T2. T3 minus T1)

Secondary outcomes

  1. Average dietary intake of micronutrients and fatty acids

    Time frame: Data collected at four time points (3 day diaries) during participant's involvement in the study via participants filling in paper food diary

    Analysis of dietary intake via Nutritics software (https://www.nutritics.com/p/references), average intake value for each micronutrient supplied by software output. This will be compared to recommended daily amounts to evaluate levels of sufficiency/insufficiency in each participant.

Sponsors and collaborators

Lead sponsor

Sheffield Hallam University

Other

Collaborators

  • Rotherham Doncaster and South Humber NHS Foundation Trust
  • Sheffield Teaching Hospitals NHS Foundation Trust

Registry information

Official study title

Micronutrient Intervention Effects on Cognitive Outcomes in Post-Acute Traumatic Brain Injury

Important dates

Study start
2017
Primary completion
2020
Study completion
2020
First posted
Jan 26, 2017
Registry last updated
Oct 22, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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