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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified November 2011 by Isfahan University of Medical Sciences.
Recruitment status was  Recruiting
Sponsor:
Information provided by (Responsible Party):
Masoud Etemadifar, Isfahan University of Medical Sciences
ClinicalTrials.gov Identifier:
NCT01465893
First received: October 28, 2011
Last updated: November 21, 2011
Last verified: November 2011
  Purpose

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


Condition Intervention Phase
Optic Neuritis
Drug: Vitamin D
Drug: Vitamin D withheld
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Official Title: The Investigation Effect of Vitamin D on Retinal Changes in Patient With Optic Neuritis by Optic Coherence Tomography

Resource links provided by NLM:


Further study details as provided by Isfahan University of Medical Sciences:

Primary Outcome Measures:
  • measurement Retinal nerve fiber layer (RNFL) thickness by OCT [ Time Frame: 10-32 days after optic neuritis ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • measurement RNFL thickness by OCT [ Time Frame: 6 months after optic neuritis ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 60
Study Start Date: July 2011
Estimated Study Completion Date: December 2012
Estimated Primary Completion Date: July 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   15 Years to 50 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01465893

Locations
Iran, Islamic Republic of
Isfahan Medical University Recruiting
Tehran, Iran, Islamic Republic of
Contact: mehri salari, neurology resident    09124972186    mehri.salari@yahoo.com   
Principal Investigator: masoud etemadifar, neurology proffesor         
Principal Investigator: mehri salari, neurology resident         
Sponsors and Collaborators
Isfahan University of Medical Sciences
  More Information

No publications provided

Responsible Party: Masoud Etemadifar, neurology proffesor, Isfahan University of Medical Sciences
ClinicalTrials.gov Identifier: NCT01465893     History of Changes
Other Study ID Numbers: isfahan medical university
Study First Received: October 28, 2011
Last Updated: November 21, 2011
Health Authority: Iran: Ethics Committee

Keywords provided by Isfahan University of Medical Sciences:
vitamin d

Additional relevant MeSH terms:
Neuritis
Optic Neuritis
Peripheral Nervous System Diseases
Neuromuscular Diseases
Nervous System Diseases
Optic Nerve Diseases
Cranial Nerve Diseases
Eye Diseases
Vitamin D
Ergocalciferols
Vitamins
Bone Density Conservation Agents
Physiological Effects of Drugs
Pharmacologic Actions
Micronutrients
Growth Substances

ClinicalTrials.gov processed this record on April 17, 2014