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NCT01465893 Clinical Trial

Effect of Vitamin D on Retinal Changes in Patient With Optic Neuritis by Optic Coherence Tomography

Optic Neuritis Clinical Trial

Official title:
The Investigation Effect of Vitamin D on Retinal Changes in Patient With Optic Neuritis by Optic Coherence Tomography

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT01465893
Other study ID # isfahan medical university
Secondary ID
Status Recruiting
Phase Phase 2
First received October 28, 2011
Last updated November 21, 2011
Start date July 2011
Est. completion date December 2012

Study information
Verified date November 2011
Source Isfahan University of Medical Sciences
Contact n/a
Is FDA regulated No
Health authority Iran: Ethics Committee
Study type Interventional

Clinical Trial Summary

This study examines the effect of vitamin D on Retinal changes in patient with optic Neuritis.

Recruitment information / eligibility
Status Recruiting
Enrollment 60
Est. completion date December 2012
Est. primary completion date July 2012
Accepts healthy volunteers No
Gender Both
Age group 15 Years to 50 Years
Eligibility Inclusion Criteria:

- age 15-50 years

- no history of demyelinative events

- level of vitamin d below 20 ng/ml

- no pass 10-32 day from starting symptom

Exclusion Criteria:

- using vitamin D supplement

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Drug:
• Vitamin D
vitamin D ,50000 unit /week
• Vitamin D withheld
do not receive anything

Locations
Country Name City State
Iran, Islamic Republic of Isfahan Medical University Tehran

Sponsors (1)
Lead Sponsor Collaborator
Isfahan University of Medical Sciences

Country where clinical trial is conducted

Iran, Islamic Republic of, 

Outcome
Type Measure Description Time frame Safety issue
Primary measurement Retinal nerve fiber layer (RNFL) thickness by OCT 10-32 days after optic neuritis Yes
Secondary measurement RNFL thickness by OCT 6 months after optic neuritis Yes
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