Optic NeuritisPhase 2NCT01465893
Effect of Vitamin D on Retinal Changes in Patient With Optic Neuritis by Optic Coherence Tomography
A Phase 2 study testing Vitamin D and Vitamin D withheld in people with Optic Neuritis, run by Isfahan University of Medical Sciences at 1 site in Iran.
Trial summary
This study examines the effect of vitamin D on Retinal changes in patient with optic Neuritis. Read more about this study
- Who is it for?
- Ages 15 to 50 years
- Conditions the study is for
- Optic Neuritis
- What is being tested?
- Vitamin D and Vitamin D withheld
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteIran
- Study dates
- Jul 2011to Dec 2012
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 15 to 50 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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
Who cannot join
- using vitamin D supplement
Trial locations and contacts
1 site in 1 country.
Iran1 site, 1 recruiting
- Recruiting
Isfahan Medical University
Tehran
mehri salari, neurology resident, 09124972186, mehri.salari@yahoo.com
masoud etemadifar, neurology proffesor
About this study
Official title: The Investigation Effect of Vitamin D on Retinal Changes in Patient With Optic Neuritis by Optic Coherence Tomography
This study examines the effect of vitamin D on Retinal changes in patient with optic Neuritis.
- Conditions
- Optic Neuritis
- Being tested
- Vitamin D, Vitamin D withheld
- Keywords
- vitamin d
- Medical subject headings
- Optic Neuritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vitamin DDrug
vitamin D ,50000 unit /week
Vitamin D withheldDrug
do not receive anything
| Study group | Role | What they receive |
|---|---|---|
| vitamin D | Active comparator | vitamin d 50000/w Receives: Drug: Vitamin D |
| control | Sham comparator | follow up Receives: Drug: Vitamin D withheld |
What is being measured
The primary outcome is the main question the study is designed to answer.
measurement Retinal nerve fiber layer (RNFL) thickness by OCT
Measured: 10-32 days after optic neuritis
Secondary outcomes (1)
measurement RNFL thickness by OCT
Measured: 6 months after optic neuritis
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Nov 2011 (estimated)
- Study startJul 2011
- Primary completionJul 2012 (estimated)
- Study completionDec 2012 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Optic NeuritisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Isfahan University of Medical Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Masoud Etemadifar, Isfahan University of Medical Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01465893
- Sponsor's protocol ID
- isfahan medical university
- Status last verified
- Nov 2011
- First submitted
- 28 Oct 2011
- Last updated
- 22 Nov 2011
- Results posted
- No
Publications
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.
PubMed 26109993
Study at a glance
From the registry record, last updated by the sponsor on 22 Nov 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Investigation Effect of Vitamin D on Retinal Changes in Patient With Optic Neuritis by Optic Coherence Tomography
- ClinicalTrials.gov ID
- NCT01465893
- Acronym / sponsor ID
- isfahan medical university
- Conditions
- Optic Neuritis
- Keywords
- vitamin d
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Isfahan University of Medical SciencesUniversity, hospital or other
- Study start
- Jul 2011
- Primary completion
- Jul 2012 (estimated)
- Study completion
- Dec 2012 (estimated)
- First posted
- 7 Nov 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study examines the effect of vitamin D on Retinal changes in patient with optic Neuritis.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| vitamin D | Active comparator | Drug: Vitamin Dvitamin d 50000/w |
| control | Sham comparator | Drug: Vitamin D withheldfollow up |
Who may qualify
- Ages
- 15 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (1 listed)
- using vitamin D supplement
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Vitamin Dvitamin D ,50000 unit /week | Drug | vitamin D |
| Vitamin D withhelddo not receive anything | Drug | control |
Primary outcome
measurement Retinal nerve fiber layer (RNFL) thickness by OCT
Time frame: 10-32 days after optic neuritis
1 secondary outcome
measurement RNFL thickness by OCT
Time frame: 6 months after optic neuritis
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Nov 2011.
- Derived from this study: PubMed 26109993Salari 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Vitamin D and Vitamin D withheld in people with Optic Neuritis, run by Isfahan University of Medical Sciences at 1 site in Iran.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 22 Nov 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Iran. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
measurement Retinal nerve fiber layer (RNFL) thickness by OCT (time frame: 10-32 days after optic neuritis). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01465893, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Nov 2011.