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

November 21, 2011 updated by: Masoud Etemadifar, Isfahan University of Medical Sciences

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

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

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

60

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Iran, Islamic Republic of
      • Tehran, Iran, Islamic Republic of
        • Recruiting
        • Isfahan Medical University
        • Contact:
        • Principal Investigator:
          • masoud etemadifar, neurology proffesor
        • Principal Investigator:
          • mehri salari, neurology resident

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

15 years to 50 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: vitamin D
vitamin d 50000/w
Drug: Vitamin D
vitamin D ,50000 unit /week
Sham Comparator: control
follow up
Drug: Vitamin D withheld
do not receive anything

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
measurement Retinal nerve fiber layer (RNFL) thickness by OCT
Time Frame: 10-32 days after optic neuritis
10-32 days after optic neuritis

Secondary Outcome Measures

Outcome Measure
Time Frame
measurement RNFL thickness by OCT
Time Frame: 6 months after optic neuritis
6 months after optic neuritis

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Isfahan University of Medical Sciences

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2011

Primary Completion (Anticipated)

July 1, 2012

Study Completion (Anticipated)

December 1, 2012

Study Registration Dates

First Submitted

October 28, 2011

First Submitted That Met QC Criteria

November 4, 2011

First Posted (Estimate)

November 6, 2011

Study Record Updates

Last Update Posted (Estimate)

November 22, 2011

Last Update Submitted That Met QC Criteria

November 21, 2011

Last Verified

November 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • isfahan medical university

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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