NCT02382679

Vitamin Therapy in Concussion Management: A Randomized Control Trial

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 20 (actual)
• Sponsor: Thomas Jefferson University · Academic / Other
• Sex: All
• Age: 11 Years – 22 Years
• Healthy volunteers: Accepted

Summary

The purpose of this study is to assess the efficacy of vitamin therapy in concussion when compared to placebo with respect to multiple endpoints including symptom severity, cognitive performance on computer based neuropsychological testing, post-concussion balance assessment, and post-concussion vestibular-oculomotor function.

Detailed description

To date, very little data exists on the use of vitamin supplementation to aid in the recovery of concussion. Data previously published shows potential benefit of certain vitamins in the management of migraine headache. These vitamins, Vitamin B2 (Riboflavin), Magnesium, Co-Enzyme Q-10, and Omega-3 fatty acids, at dosages described in the literature, are being used based on the migraine literature findings and anecdotal evidence to help treat complaints of headache in concussion management.

Conditions

• Concussion

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	Experimental: Vitamin Mixture	Vitamins: B2 (riboflavin), magnesium, co-enzyme Q10, Omega 3 fatty acids
DIETARY_SUPPLEMENT	Placebo	Non-nutritional non-immunogenic non-allergic oil-based capsule with same appearance, weight and density of active experimental vitamin.

Timeline

• Start date: 2015-03-01
• Primary completion: 2016-05-01
• Completion: 2016-05-01
• First posted: 2015-03-09
• Last updated: 2022-04-13