Traumatic Brain InjuryNCT03032302
Micronutrient Supplement Effects on Cognitive Outcomes in Post-Acute TBI
A study testing Swisse Womens 50+ Ultivite Multivitamin and Holland and Barrett Triple Strength Omega-3 Fish Oil in people with Traumatic Brain Injury, run by Sheffield Hallam University at 1 site in United Kingdom.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Traumatic Brain Injury
- What is being tested?
- Swisse Womens 50+ Ultivite Multivitamin and Holland and Barrett Triple Strength Omega-3 Fish Oil
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 1 Oct 2017to 18 Apr 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- First and only traumatic brain injury.
- Complex mild to moderate injury.
- 3-24 months post-injury
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Sheffield Hallam University
Sheffield, South Yorkshire, S10 2BQ
About this study
Official title: 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).
Read the 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
- Being tested
- Swisse Womens 50+ Ultivite Multivitamin, Holland and Barrett Triple Strength Omega-3 Fish Oil
- Keywords
- TBI
- Medical subject headings
- Brain Injuries, Traumatic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Swisse Womens 50+ Ultivite MultivitaminDietary supplement
Single tablet taken once daily
Holland and Barrett Triple Strength Omega-3 Fish OilDietary supplement
Single capsule taken once daily
| Study group | Role | What they receive |
|---|---|---|
| Multivitamin | Experimental | Swisse Womens 50+ Ultivite Multivitamin. Once daily. Receives: 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 Receives: 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) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: Three time points: baseline (T1), 8 weeks (T2) and 22 weeks (T3)
Secondary outcomes (1)
Average dietary intake of micronutrients and fatty acids
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.
Measured: Data collected at four time points (3 day diaries) during participant's involvement in the study via participants filling in paper food diary
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jan 2017 (estimated)
- Study start1 Oct 2017
- Primary completion18 Apr 2020
- Study completion18 Apr 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (11)Papers the sponsor has linked to this study.
- Other trials for Traumatic Brain InjuryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sheffield Hallam University
- Sponsor type
- University, hospital or other
- Collaborators
- Sheffield Teaching Hospitals NHS Foundation Trust, Rotherham Doncaster and South Humber NHS Foundation Trust
- Responsible party
- Sponsor
- Investigators
- Lynne A Barker, PhD, Study director, Sheffield Hallam University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03032302
- Sponsor's protocol ID
- STH19529
- Status last verified
- Oct 2020
- First submitted
- 22 Dec 2016
- Last updated
- 22 Oct 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 16754282Bombardier 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.
PubMed 20483970Borzotta 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.
PubMed 8083910Cook 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.
PubMed 19033220Ames 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.
PubMed 20420847Balion 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.
PubMed 23008220Bitarafan 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.
PubMed 24800044Nimitphong 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.
PubMed 21102318Oudshoorn 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.
PubMed 18503256Amen 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.
PubMed 21615001Lucke-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.
PubMed 40440029
Study at a glance
From the registry record, last updated by the sponsor on 22 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Micronutrient Intervention Effects on Cognitive Outcomes in Post-Acute Traumatic Brain Injury
- ClinicalTrials.gov ID
- NCT03032302
- Acronym / sponsor ID
- STH19529
- Conditions
- Traumatic Brain Injury
- Keywords
- TBI
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Sheffield Hallam UniversityUniversity, hospital or other
- Collaborators
- Sheffield Teaching Hospitals NHS Foundation Trust, Rotherham Doncaster and South Humber NHS Foundation Trust
- Study start
- 1 Oct 2017 (actual)
- Primary completion
- 18 Apr 2020 (actual)
- Study completion
- 18 Apr 2020 (actual)
- First posted
- 26 Jan 2017 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Multivitamin | Experimental | Dietary Supplement: Swisse Womens 50+ Ultivite Multivitamin, Dietary Supplement: Holland and Barrett Triple Strength Omega-3 Fish OilSwisse Womens 50+ Ultivite Multivitamin. Once daily. |
| Omega-3 Fatty Acids | Experimental | Dietary Supplement: Swisse Womens 50+ Ultivite Multivitamin, Dietary Supplement: Holland and Barrett Triple Strength Omega-3 Fish OilHolland and Barrett Triple Strength Omega-3 Fish Oils. Once Daily |
| Control | No intervention | –Treatment as usual (cognitive rehabilitation, occupational therapy, physiotherapy; as required) |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- First and only traumatic brain injury.
- Complex mild to moderate injury.
- 3-24 months post-injury
Key exclusion criteria (6 listed)
- Unable to give informed consent.
- Already taking micronutrient/fatty acid supplements.
- Hemianopia
- Hemiplegia.
- Pregnant or breastfeeding.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Swisse Womens 50+ Ultivite MultivitaminSingle tablet taken once daily | Dietary supplement | Multivitamin, Omega-3 Fatty Acids |
| Holland and Barrett Triple Strength Omega-3 Fish OilSingle capsule taken once daily | Dietary supplement | Multivitamin, Omega-3 Fatty Acids |
Primary outcome
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)
1 secondary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Oct 2020.
- Background: PubMed 16754282Lippert-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.
- Background: PubMed 20483970Bombardier 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.
- Background: PubMed 8083910Borzotta 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.
- Background: PubMed 19033220Cook 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.
- Background: PubMed 20420847Ames 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.
- Background: PubMed 23008220Balion 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.
- Background: PubMed 24800044Bitarafan 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.
- Background: PubMed 21102318Nimitphong 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.
- Background: PubMed 18503256Oudshoorn 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.
- Background: PubMed 21615001Amen 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.
- Derived from this study: PubMed 40440029Lucke-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.
- NutriticsLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lynne A Barker, PhD study director
Sheffield Hallam University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Swisse Womens 50+ Ultivite Multivitamin and Holland and Barrett Triple Strength Omega-3 Fish Oil in people with Traumatic Brain Injury, run by Sheffield Hallam University at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Oct 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03032302, which also lists 11 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Oct 2020.