Effect of Vitamin D on Retinal Changes in Patient With Op... | NCT01465893

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

NCT01465893

Sponsor

Isfahan University of Medical Sciences

Status

Unknown status

Last Update Posted

Nov 22, 2011Estimated

Enrollment

60Estimated

Phase

Phase 2

Conditions

Optic Neuritis

Interventions

Vitamin D
Vitamin D withheld

Countries

Iran

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Nov 2011

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jul 2011

Primary Completion Date

Jul 2012Estimated

Completion Date

Dec 2012Estimated

First Submitted Date

Oct 28, 2011

First Submission Date that Met QC Criteria

Nov 4, 2011

First Posted Date

Nov 7, 2011Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Nov 21, 2011

Last Update Posted Date

Nov 22, 2011Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Masoud Etemadifar, neurology proffesor, Isfahan University of Medical SciencesPrincipal Investigator

Lead Sponsor

Isfahan University of Medical SciencesOTHER

Collaborators

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

60Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
vitamin D	Active Comparator	vitamin d 50000/w	Drug: Vitamin D
control	Sham Comparator	follow up	Drug: Vitamin D withheld

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Vitamin D	Drug	vitamin D ,50000 unit /week	vitamin D
Vitamin D withheld

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

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

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

15 Years

Maximum Age

50 Years

Standard Ages

ChildAdult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Isfahan Medical University	Recruiting	Tehran			Iran

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
26109993	Derived	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.

ID	Term
D009901	Optic Nerve Diseases
D003389	Cranial Nerve Diseases
D009422	Nervous System Diseases
D005128	Eye Diseases

ID	Term
D012632	Secosteroids
D013256	Steroids
D000072473	Fused-Ring Compounds
D011083	Polycyclic Compounds