Optic neuritis. Optic neuritis
Conditions
Interventions
Intervention 1: Administration of vitamin D3 at a dosage of 50000IU/week in the form of oral pearls to treatment group for 12 months. Intervention 2: Administration of a similar pearl shape placebo to
Treatment - Drugs
Placebo
Administration of vitamin D3 at a dosage of 50000IU/week in the form of oral pearls to treatment group for 12 months.
Administration of a similar pearl shape placebo to control group for 12 months
Sponsors
Isfahan University of Medical Sciences
Eligibility
Sex/Gender
All
Age
20 Years to 40 Years
Inclusion criteria
Inclusion criteria: Entry criteria were as follows: (1) optic neuritis male or female patients with age range of 20-40 years, (2) patients should not fulfill the 2005 revised Mc Donald Criteria for multiple sclerosis, at the time of inclusion in the study,(3) serum 25(OH)D level of less than 30ng/ml (4) seronegativity for anti-aquaporin4 and other autoimmune antibodies, Exclusion criteria are:(1) patients who have used vitamin D supplements at a level higher than 400IU/day before the onset of optic neuritis,(2)patients who used any medication that could influence the prognosis of optic neuritis (e.g. ß interferon) during the 12 months follow-up period,(3) women who were pregnant or breast feeding,(4) patients with kidney or liver dysfunction, (5)patients who demonstrated poor compliance with instructions to take vitamin D or placebo,or who failed to attend for follow- up visits, MRI scanning and vitamin D measurements during the study,(6)patients with a history of nephrolithiasis and(7) patients suffering from concurrent granulomatous diseases.
Exclusion criteria
Exclusion criteria:
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The incidence rate of new demyelinative attack(s). Timepoint: before and after the study. Method of measurement: complain(s) of patients, physical examination and MRI. | — |
Secondary
| Measure | Time frame |
|---|---|
| The changes in MRI lesions. Timepoint: before and after study,during new attack(s). Method of measurement: counting of MRI plaques. | — |
Countries
Iran (Islamic Republic of)
Contacts
Public ContactHajar Derakhshandi
Medical School of Isfahan University of Medical Sciences
Outcome results
None listed