Relapsing Remitting Multiple Sclerosis Clinical Trial
Official title:
Isfahan University of Medical Sciences
Verified date | February 2016 |
Source | Isfahan University of Medical Sciences |
Contact | n/a |
Is FDA regulated | No |
Health authority | Iran: Ministry of Health |
Study type | Interventional |
This study aimed to evaluate oral and injectable routes in treatment of hypovitaminosis D in multiple sclerosis (MS) patients. The investigators aimed to assess the efficacy of each method, using the same Mega dose of 600 000 IU D3, in achieving normal serum 25(OH)D level, the durability of the response, the practicality and the possible toxicity.
Status | Completed |
Enrollment | 200 |
Est. completion date | December 2015 |
Est. primary completion date | November 2015 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Both |
Age group | 23 Years to 59 Years |
Eligibility |
Inclusion Criteria: - with serum 25(OH)D3 concentration = 20 ng/ml Exclusion Criteria: - hypercalcaemia, primary hyperparathyroidism, Paget disease, thyrotoxicosis, pregnancy, active malignancy, hypercalciuria, history of liver disease, renal insufficiency, clinically apparent malabsorption syndrome, using drugs containing vitamin D products, calcium, estrogen and drugs known to affect vitamin D metabolism (anticonvulsants, glucocorticoids) or receiving any form of supplements containing vitamin D during last 6 months. - Participants with serum 25(OH)D concentration= 20 ng/ml |
Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Iran, Islamic Republic of | Alzahra Hospital | Isfahan |
Lead Sponsor | Collaborator |
---|---|
Isfahan University of Medical Sciences |
Iran, Islamic Republic of,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Serum concentration of 25(OH)D | Two Weeks | Yes |
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