NCT01465893

Brief Summary

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Jul 2011

Shorter than P25 for phase_2

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2011

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

October 28, 2011

Completed
10 days until next milestone

First Posted

Study publicly available on registry

November 7, 2011

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2012

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2012

Completed
Last Updated

November 22, 2011

Status Verified

November 1, 2011

Enrollment Period

1 year

First QC Date

October 28, 2011

Last Update Submit

November 21, 2011

Conditions

Optic Neuritis

Keywords

vitamin d

Outcome Measures

Primary Outcomes (1)

  • measurement Retinal nerve fiber layer (RNFL) thickness by OCT

    10-32 days after optic neuritis

Secondary Outcomes (1)

  • measurement RNFL thickness by OCT

    6 months after optic neuritis

Study Arms (2)

vitamin D

ACTIVE COMPARATOR

vitamin d 50000/w

Drug: Vitamin D

control

SHAM COMPARATOR

follow up

Drug: Vitamin D withheld

Interventions

Vitamin DDRUG

vitamin D ,50000 unit /week

vitamin D
Vitamin D withheldDRUG

do not receive anything

control

Eligibility Criteria

Age15 Years - 50 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • using vitamin D supplement

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Isfahan Medical University

Tehran, Iran

RECRUITING

Related Publications (1)

  • 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.

    PMID: 26109993DERIVED

MeSH Terms

Conditions

Optic Neuritis

Interventions

Vitamin D

Condition Hierarchy (Ancestors)

Optic Nerve DiseasesCranial Nerve DiseasesNervous System DiseasesEye Diseases

Intervention Hierarchy (Ancestors)

SecosteroidsSteroidsFused-Ring CompoundsPolycyclic Compounds

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
neurology proffesor

Study Record Dates

First Submitted

October 28, 2011

First Posted

November 7, 2011

Study Start

July 1, 2011

Primary Completion

July 1, 2012

Study Completion

December 1, 2012

Last Updated

November 22, 2011

Record last verified: 2011-11

Locations

IR(1)