CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 4 enrolled
Drug / intervention
Selenium +1 moredietary
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01904591
NCT01904591N/ACompleted

The Effects of Anti-oxidants on Clinical Outcomes and Radiological Features of Chronic Spinal Cord Injury: A Pilot Study

McMaster University·interventional·Posted Jul 22, 2013·Updated Sep 13, 2016

In Brief

A clinical study evaluating Selenium and Vitamin E for Spinal Cord Injury. Completed, enrolled 4 participants across 1 site.

Detailed Summary

This study will enroll 10 adults with a chronic spinal cord injury. The investigators will image their damaged motor tracts using MRI tractography scanning, and the investigators will formally assess their ASIA motor level at the outset of the study. Then, the investigators will treat them with one year of 'over the counter' dosage of selenium and vitamin E. These are two vitamins known to be anti-oxidants. After one year the investigators will repeat the MRI scans and ASIA assessments to determine if their has been any change in the appearance of motor tracts on MRI tractography, or in motor level on ASIA exam. As this is a pilot study the investigators are primarily concerned with establishing safety of this intervention, with a view to conducting a larger and more rigorous controlled trial in the future. The investigators also have a small hope that in fact some improvement might be found with vitamin treatment.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesCanada
Collaborators--

Timeline

N/ACompletedFinished
2014201520162017201820192020202120222023202420252026
First PostedJul 22, 2013
Enrollment StartOct 1, 2013
Primary CompletionJul 1, 2016
TodayJul 2, 2026
Enrollment to primary: 2.8 yearsPosted 12.9 years ago

Interventions

Seleniumdietary

Selenium 50 micrograms daily per oral 1 year of treatment

Vitamin Edietary

Vitamin E 400 international units daily per oral 1 year of treatment