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Micronutrient Supplement Effects on Cognitive Outcomes in Post-Acute TBI

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ClinicalTrials.gov Identifier: NCT03032302
Recruitment Status : Completed
First Posted : January 26, 2017
Last Update Posted : October 22, 2020
Sponsor:
Collaborators:
Sheffield Teaching Hospitals NHS Foundation Trust
Rotherham Doncaster and South Humber NHS Foundation Trust
Information provided by (Responsible Party):
Sheffield Hallam University

Tracking Information
First Submitted Date  ICMJE December 22, 2016
First Posted Date  ICMJE January 26, 2017
Last Update Posted Date October 22, 2020
Actual Study Start Date  ICMJE October 1, 2017
Actual Primary Completion Date April 18, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 23, 2017)
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)
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: September 6, 2019)
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.
Original Secondary Outcome Measures  ICMJE
 (submitted: January 23, 2017)
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.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Micronutrient Supplement Effects on Cognitive Outcomes in Post-Acute TBI
Official Title  ICMJE Micronutrient Intervention Effects on Cognitive Outcomes in Post-Acute Traumatic Brain Injury
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Supportive Care
Condition  ICMJE Traumatic Brain Injury
Intervention  ICMJE
  • 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
Study Arms  ICMJE
  • Experimental: Multivitamin
    Swisse Womens 50+ Ultivite Multivitamin. Once daily.
    Interventions:
    • Dietary Supplement: Swisse Womens 50+ Ultivite Multivitamin
    • Dietary Supplement: Holland and Barrett Triple Strength Omega-3 Fish Oil
  • Experimental: Omega-3 Fatty Acids
    Holland and Barrett Triple Strength Omega-3 Fish Oils. Once Daily
    Interventions:
    • Dietary Supplement: Swisse Womens 50+ Ultivite Multivitamin
    • Dietary Supplement: Holland and Barrett Triple Strength Omega-3 Fish Oil
  • No Intervention: Control
    Treatment as usual (cognitive rehabilitation, occupational therapy, physiotherapy; as required)
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: December 2, 2019)
30
Original Estimated Enrollment  ICMJE
 (submitted: January 23, 2017)
60
Actual Study Completion Date  ICMJE April 18, 2020
Actual Primary Completion Date April 18, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 70 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United Kingdom
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03032302
Other Study ID Numbers  ICMJE STH19529
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Sheffield Hallam University
Study Sponsor  ICMJE Sheffield Hallam University
Collaborators  ICMJE
  • Sheffield Teaching Hospitals NHS Foundation Trust
  • Rotherham Doncaster and South Humber NHS Foundation Trust
Investigators  ICMJE
Study Director: Lynne A Barker, PhD Sheffield Hallam University
PRS Account Sheffield Hallam University
Verification Date October 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP