Micronutrient Supplement Effects on Cognitive Outcomes in Post-Acute TBI

October 20, 2020 updated by: Sheffield Hallam University

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

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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

30

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United Kingdom
    • South Yorkshire
      • Sheffield, South Yorkshire, United Kingdom, S10 2BQ
        • Sheffield Hallam University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: SUPPORTIVE_CARE
  • Allocation: RANDOMIZED
  • Interventional Model: CROSSOVER
  • Masking: DOUBLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Multivitamin
Swisse Womens 50+ Ultivite Multivitamin. Once daily.
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
EXPERIMENTAL: Omega-3 Fatty Acids
Holland and Barrett Triple Strength Omega-3 Fish Oils. Once Daily
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
NO_INTERVENTION: Control
Treatment as usual (cognitive rehabilitation, occupational therapy, physiotherapy; as required)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
Three time points: baseline (T1), 8 weeks (T2) and 22 weeks (T3)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Data collected at four time points (3 day diaries) during participant's involvement in the study via participants filling in paper food diary

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sheffield Hallam University

Collaborators

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

Investigators

  • Study Director: Lynne A Barker, PhD, Sheffield Hallam University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

October 1, 2017

Primary Completion (ACTUAL)

April 18, 2020

Study Completion (ACTUAL)

April 18, 2020

Study Registration Dates

First Submitted

December 22, 2016

First Submitted That Met QC Criteria

January 23, 2017

First Posted (ESTIMATE)

January 26, 2017

Study Record Updates

Last Update Posted (ACTUAL)

October 22, 2020

Last Update Submitted That Met QC Criteria

October 20, 2020

Last Verified

October 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • STH19529

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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