Micronutrient Supplement Effects on Cognitive Outcomes in TBI
Research type
Research Study
Full title
A Study Investigating Whether Vitamin and Mineral Supplementation Enhances Cognitive Outcome in Mild to Moderate Brain Injury, Compared to a Control Group.
IRAS ID
157987
Contact name
Rebecca J Denniss
Contact email
Sponsor organisation
Sheffield Hallam University
Clinicaltrials.gov Identifier
Duration of Study in the UK
2 years, 4 months, 15 days
Research summary
Approximately 1.4 million people attend Accident and Emergency departments following head injury in England and Wales annually, with 200,000 of these admitted (National Institute of Health and Care Excellence; NICE, 2014). Traumatic brain injuries can result in diverse problems to thinking, independence, autonomy and social behaviour. Long-term consequences of such injuries place a large burden on individual families and the NHS. Cellular processes occurring within the brain tissue following traumatic brain injury are highly complex and variable. A growing body of research has been undertaken endeavouring to understand the neurobiological changes which occur following trauma, attempting to discover medical solutions to limit resultant damage in acute patients (Royo et al., 2003; Hall et al., 2010; Stein, 2011). There has, however, been little research investigating efficacy of low-cost multivitamin supplementation with post-acute head injured patients and potential benefits this may have on cognitive rehabilitation.
The proposed study would compare cognitive task performance of three matched traumatically brain injured patient groups; one group taking a multivitamin supplement for the first eight weeks and the second group taking an omega-3 supplement for the same period. Following a six-week washout period these two groups will ‘cross-over’ supplements, taking the other supplement for the following eight weeks. The third group would act as a control, taking a placebo for the length of the study. The study will recruit participants via collaborating NHS Consultant Clinical Neuropsychologists and nutritionists. Test sessions will be conducted at a place most convenient to participants, either at Sheffield Hallam University, rehabilitation centres or their own homes. Participants will complete a series of psychological tasks over a number of sessions (session length determined by participants) at baseline and at two follow-up time points. Findings should inform nutritional supplementation post head-injury.REC name
Yorkshire & The Humber - Sheffield Research Ethics Committee
REC reference
17/YH/0146
Date of REC Opinion
14 Jul 2017
REC opinion
Further Information Favourable Opinion