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Vitamin Therapy in Concussion Management: A Randomized Control Trial

NCT02382679 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2022-04-13

No results posted yet for this study

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.

Conditions

  • Concussion

Interventions

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.

Sponsors & Collaborators

  • Rothman Institute Orthopaedics

    collaborator OTHER

  • Thomas Jefferson University

    lead OTHER

Principal Investigators

  • Steve Stache, MD · Rothman Institute

  • Mijail Serruya, MD, PhD · Thomas Jefferson University

  • Robert Franks, DO · Rothman Institute

  • Jeremy Close, MD · Thomas Jefferson University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
11 Years
Max Age
22 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2015-03-31
Primary Completion
2016-05-31
Completion
2016-05-31

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02382679 on ClinicalTrials.gov