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Micronutrient Supplement Effects on Cognitive Outcomes in Post-Acute TBI

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ClinicalTrials.gov Identifier: NCT03032302
Recruitment Status : Recruiting
First Posted : January 26, 2017
Last Update Posted : April 3, 2019
Sponsor:
Collaborators:
Sheffield Teaching Hospitals NHS Foundation Trust
Rotherham Doncaster and South Humber NHS Foundation Trust
Information provided by (Responsible Party):
Sheffield Hallam University

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).


Condition or disease Intervention/treatment Phase
Traumatic Brain Injury Dietary Supplement: Swisse Womens 50+ Ultivite Multivitamin Dietary Supplement: Holland and Barrett Triple Strength Omega-3 Fish Oil Not Applicable

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 feasibility study will be conducted with a normative group (sample size 60) to inform the main trial. This study will involve random allocation to three groups, investigating two supplements with a matched control, changes in cognition measured via test-test on a cognitive battery. The current TBI study will involve three groups of individuals with post-acute traumatic brain injuries, investigating two different supplements to measure whether there is improved cognitive outcomes (measured by test-retest on a cognitive battery) associated with these supplements, when compared with a control group.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Supportive Care
Official Title: Micronutrient Intervention Effects on Cognitive Outcomes in Post-Acute Traumatic Brain Injury
Actual Study Start Date : October 1, 2017
Estimated Primary Completion Date : September 2020
Estimated Study Completion Date : September 2020

Resource links provided by the National Library of Medicine


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)



Primary Outcome Measures :
  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 Outcome Measures :
  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, 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.



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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • First and only traumatic brain injury.
  • Complex mild to moderate injury.
  • 3-12 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03032302


Contacts
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Contact: Rebecca J Denniss, MSc +114 2253417 r.denniss@shu.ac.uk

Locations
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United Kingdom
Sheffield Hallam University Recruiting
Sheffield, South Yorkshire, United Kingdom, S10 2BQ
Contact: Rebecca J Denniss, MSc    +114 2253417    r.denniss@shu.ac.uk   
Contact: Lynne A Barker, PhD    +114 2255379    l.barker@shu.ac.uk   
Sponsors and Collaborators
Sheffield Hallam University
Sheffield Teaching Hospitals NHS Foundation Trust
Rotherham Doncaster and South Humber NHS Foundation Trust
Investigators
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Study Director: Lynne A Barker, PhD Sheffield Hallam University

Additional Information:
Publications:

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Responsible Party: Sheffield Hallam University
ClinicalTrials.gov Identifier: NCT03032302     History of Changes
Other Study ID Numbers: STH19529
First Posted: January 26, 2017    Key Record Dates
Last Update Posted: April 3, 2019
Last Verified: April 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Sheffield Hallam University:
TBI

Additional relevant MeSH terms:
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Brain Injuries
Brain Injuries, Traumatic
Brain Diseases
Craniocerebral Trauma
Trauma, Nervous System
Wounds and Injuries
Central Nervous System Diseases
Nervous System Diseases
Micronutrients
Trace Elements
Nutrients
Growth Substances
Physiological Effects of Drugs