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

Primary Purpose

Optic Neuritis

Status
Unknown status
Phase
Phase 2
Locations
Iran, Islamic Republic of
Study Type
Interventional
Intervention
Vitamin D
Vitamin D withheld
Sponsored by
Isfahan University of Medical Sciences
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Optic Neuritis focused on measuring vitamin d

Eligibility Criteria

15 Years - 50 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Isfahan Medical UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Sham Comparator

Arm Label

vitamin D

control

Arm Description

vitamin d 50000/w

follow up

Outcomes

Primary Outcome Measures

measurement Retinal nerve fiber layer (RNFL) thickness by OCT

Secondary Outcome Measures

measurement RNFL thickness by OCT

Full Information

First Posted
October 28, 2011
Last Updated
November 21, 2011
Sponsor
Isfahan University of Medical Sciences
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1. Study Identification

Unique Protocol Identification Number
NCT01465893
Brief Title
Effect of Vitamin D on Retinal Changes in Patient With Optic Neuritis by Optic Coherence Tomography
Official Title
The Investigation Effect of Vitamin D on Retinal Changes in Patient With Optic Neuritis by Optic Coherence Tomography
Study Type
Interventional

2. Study Status

Record Verification Date
November 2011
Overall Recruitment Status
Unknown status
Study Start Date
July 2011 (undefined)
Primary Completion Date
July 2012 (Anticipated)
Study Completion Date
December 2012 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Isfahan University of Medical Sciences

4. Oversight

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Optic Neuritis
Keywords
vitamin d

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
vitamin D
Arm Type
Active Comparator
Arm Description
vitamin d 50000/w
Arm Title
control
Arm Type
Sham Comparator
Arm Description
follow up
Intervention Type
Drug
Intervention Name(s)
Vitamin D
Intervention Description
vitamin D ,50000 unit /week
Intervention Type
Drug
Intervention Name(s)
Vitamin D withheld
Intervention Description
do not receive anything
Primary Outcome Measure Information:
Title
measurement Retinal nerve fiber layer (RNFL) thickness by OCT
Time Frame
10-32 days after optic neuritis
Secondary Outcome Measure Information:
Title
measurement RNFL thickness by OCT
Time Frame
6 months after optic neuritis

10. Eligibility

Sex
All
Minimum Age & Unit of Time
15 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Isfahan Medical University
City
Tehran
Country
Iran, Islamic Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
mehri salari, neurology resident
Phone
09124972186
Email
mehri.salari@yahoo.com
First Name & Middle Initial & Last Name & Degree
masoud etemadifar, neurology proffesor
First Name & Middle Initial & Last Name & Degree
mehri salari, neurology resident

12. IPD Sharing Statement

Citations:
PubMed Identifier
26109993
Citation
Salari M, Janghorbani M, Etemadifar M, Dehghani A, Razmjoo H, Naderian G. Effects of vitamin D on retinal nerve fiber layer in vitamin D deficient patients with optic neuritis: Preliminary findings of a randomized, placebo-controlled trial. J Res Med Sci. 2015 Apr;20(4):372-8.
Results Reference
derived

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

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