Micronutrient Supplement Effects on Cognitive Outcomes in Post-Acute TBI

NCT03032302 | Completed

• 1 other identifier: STH19529
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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).

Conditions

Traumatic Brain Injury

Keywords

TBI

Outcome Measures

Primary Outcomes (1)

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

  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 Outcomes (1)

• Average dietary intake of micronutrients and fatty acids

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

Study Arms (3)

Multivitamin

EXPERIMENTAL

Swisse Womens 50+ Ultivite Multivitamin. Once daily.

Dietary Supplement: Swisse Womens 50+ Ultivite Multivitamin; Dietary Supplement: Holland and Barrett Triple Strength Omega-3 Fish Oil

Omega-3 Fatty Acids

EXPERIMENTAL

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

Dietary Supplement: Swisse Womens 50+ Ultivite Multivitamin; Dietary Supplement: Holland and Barrett Triple Strength Omega-3 Fish Oil

Control

NO INTERVENTION

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

Interventions

Swisse Womens 50+ Ultivite Multivitamin DIETARY_SUPPLEMENT

Single tablet taken once daily

Multivitamin; Omega-3 Fatty Acids

Holland and Barrett Triple Strength Omega-3 Fish Oil DIETARY_SUPPLEMENT

Single capsule taken once daily

Multivitamin; Omega-3 Fatty Acids

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Sheffield Hallam University: lead
• Sheffield Teaching Hospitals NHS Foundation Trust: collaborator
• Rotherham Doncaster and South Humber NHS Foundation Trust: collaborator

Study Sites (1)

Sheffield Hallam University

Sheffield, South Yorkshire, S10 2BQ, United Kingdom

Location

Related Publications (11)

• Lippert-Gruner M, Kuchta J, Hellmich M, Klug N. Neurobehavioural deficits after severe traumatic brain injury (TBI). Brain Inj. 2006 Jun;20(6):569-74. doi: 10.1080/02699050600664467.

  PMID: 16754282 BACKGROUND

• Bombardier CH, Fann JR, Temkin NR, Esselman PC, Barber J, Dikmen SS. Rates of major depressive disorder and clinical outcomes following traumatic brain injury. JAMA. 2010 May 19;303(19):1938-45. doi: 10.1001/jama.2010.599.

  PMID: 20483970 BACKGROUND

• Borzotta AP, Pennings J, Papasadero B, Paxton J, Mardesic S, Borzotta R, Parrott A, Bledsoe F. Enteral versus parenteral nutrition after severe closed head injury. J Trauma. 1994 Sep;37(3):459-68. doi: 10.1097/00005373-199409000-00022.

  PMID: 8083910 BACKGROUND

• Cook AM, Peppard A, Magnuson B. Nutrition considerations in traumatic brain injury. Nutr Clin Pract. 2008 Dec-2009 Jan;23(6):608-20. doi: 10.1177/0884533608326060.

  PMID: 19033220 BACKGROUND

• Ames BN. Optimal micronutrients delay mitochondrial decay and age-associated diseases. Mech Ageing Dev. 2010 Jul-Aug;131(7-8):473-9. doi: 10.1016/j.mad.2010.04.005. Epub 2010 Apr 24.

  PMID: 20420847 BACKGROUND

• Balion C, Griffith LE, Strifler L, Henderson M, Patterson C, Heckman G, Llewellyn DJ, Raina P. Vitamin D, cognition, and dementia: a systematic review and meta-analysis. Neurology. 2012 Sep 25;79(13):1397-405. doi: 10.1212/WNL.0b013e31826c197f.

  PMID: 23008220 BACKGROUND

• Bitarafan S, Harirchian MH, Nafissi S, Sahraian MA, Togha M, Siassi F, Saedisomeolia A, Alipour E, Mohammadpour N, Chamary M, Honarvar NM, Saboor-Yaraghi AA. Dietary intake of nutrients and its correlation with fatigue in multiple sclerosis patients. Iran J Neurol. 2014;13(1):28-32.

  PMID: 24800044 BACKGROUND

• Nimitphong H, Holick MF. Vitamin D, neurocognitive functioning and immunocompetence. Curr Opin Clin Nutr Metab Care. 2011 Jan;14(1):7-14. doi: 10.1097/MCO.0b013e3283414c38.

  PMID: 21102318 BACKGROUND

• Oudshoorn C, Mattace-Raso FU, van der Velde N, Colin EM, van der Cammen TJ. Higher serum vitamin D3 levels are associated with better cognitive test performance in patients with Alzheimer's disease. Dement Geriatr Cogn Disord. 2008;25(6):539-43. doi: 10.1159/000134382. Epub 2008 May 26.

  PMID: 18503256 BACKGROUND

• Amen DG, Wu JC, Taylor D, Willeumier K. Reversing brain damage in former NFL players: implications for traumatic brain injury and substance abuse rehabilitation. J Psychoactive Drugs. 2011 Jan-Mar;43(1):1-5. doi: 10.1080/02791072.2011.566489.

  PMID: 21615001 BACKGROUND

• Lucke-Wold B, Zasler ND, Ruchika F, Weisman S, Le D, Brunicardi J, Kong I, Ghumman H, Persad S, Mahan D, Delawan M, Shah S, Aghili-Mehrizi S. Supplement and nutraceutical therapy in traumatic brain injury. Nutr Neurosci. 2025 Jun;28(6):709-743. doi: 10.1080/1028415X.2024.2404782. Epub 2024 Dec 30.

  PMID: 40440029 DERIVED

Related Links

• Nutritics

MeSH Terms

Conditions

Brain Injuries, Traumatic

Condition Hierarchy (Ancestors)

Brain Injuries; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Wounds and Injuries

Study Officials

• Lynne A Barker, PhD

  Sheffield Hallam University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 22, 2016
• First Posted: January 26, 2017
• Study Start: October 1, 2017
• Primary Completion: April 18, 2020
• Study Completion: April 18, 2020
• Last Updated: October 22, 2020

Record last verified: 2020-10

Locations

GB (1)