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

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ClinicalTrials.gov Identifier: NCT01465893
Recruitment Status : Unknown
Verified November 2011 by Masoud Etemadifar, Isfahan University of Medical Sciences.
Recruitment status was:  Recruiting
First Posted : November 7, 2011
Last Update Posted : November 22, 2011
Sponsor:
Information provided by (Responsible Party):
Masoud Etemadifar, Isfahan University of Medical Sciences

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

Condition or disease Intervention/treatment Phase
Optic Neuritis Drug: Vitamin D Drug: Vitamin D withheld Phase 2

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: The Investigation Effect of Vitamin D on Retinal Changes in Patient With Optic Neuritis by Optic Coherence Tomography
Study Start Date : July 2011
Estimated Primary Completion Date : July 2012
Estimated Study Completion Date : December 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Vitamin D
Drug Information available for: Vitamin D

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




Primary Outcome Measures :
  1. measurement Retinal nerve fiber layer (RNFL) thickness by OCT [ Time Frame: 10-32 days after optic neuritis ]

Secondary Outcome Measures :
  1. measurement RNFL thickness by OCT [ Time Frame: 6 months after optic neuritis ]


Information from the National Library of Medicine

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Ages Eligible for Study:   15 Years to 50 Years   (Child, Adult)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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
First Posted: November 7, 2011    Key Record Dates
Last Update Posted: November 22, 2011
Last Verified: November 2011

Keywords provided by Masoud Etemadifar, Isfahan University of Medical Sciences:
vitamin d

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