Micronutrient Supplement Effects on Cognitive Outcomes in Post-Acute TBI

NCT ID: NCT03032302

Last Updated: 2020-10-22

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-10-01
• Study Completion Date: 2020-04-18

Brief 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.

Conditions

Traumatic Brain Injury

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: DOUBLE

Study Groups

Multivitamin

Swisse Womens 50+ Ultivite Multivitamin. Once daily.

Group Type: EXPERIMENTAL

Swisse Womens 50+ Ultivite Multivitamin

Intervention Type: DIETARY_SUPPLEMENT

Single tablet taken once daily

Holland and Barrett Triple Strength Omega-3 Fish Oil

Intervention Type: DIETARY_SUPPLEMENT

Single capsule taken once daily

Omega-3 Fatty Acids

Holland and Barrett Triple Strength Omega-3 Fish Oils. Once Daily

Group Type: EXPERIMENTAL

Swisse Womens 50+ Ultivite Multivitamin

Intervention Type: DIETARY_SUPPLEMENT

Single tablet taken once daily

Holland and Barrett Triple Strength Omega-3 Fish Oil

Intervention Type: DIETARY_SUPPLEMENT

Single capsule taken once daily

Control

Treatment as usual (cognitive rehabilitation, occupational therapy, physiotherapy; as required)

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Swisse Womens 50+ Ultivite Multivitamin

Single tablet taken once daily

Intervention Type: DIETARY_SUPPLEMENT

Holland and Barrett Triple Strength Omega-3 Fish Oil

Single capsule taken once daily

Intervention Type: DIETARY_SUPPLEMENT

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Sheffield Teaching Hospitals NHS Foundation Trust

OTHER

Sponsor Role: collaborator

Rotherham Doncaster and South Humber NHS Foundation Trust

OTHER_GOV

Sponsor Role: collaborator

Sheffield Hallam University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Lynne A Barker, PhD

Role: STUDY_DIRECTOR

Sheffield Hallam University

Locations

Sheffield Hallam University

Sheffield, South Yorkshire, United Kingdom

Countries

United Kingdom

References

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Reference Type: BACKGROUND

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Related Links

https://www.nutritics.com/p/references

Nutritics

Other Identifiers

STH19529

Identifier Type: -

Identifier Source: org_study_id