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High Dose Oral Versus Intramuscular Vitamin D3 Supplementation In Multiple Sclerosis Patients

Not Applicable
Completed
Conditions
Relapsing Remitting Multiple Sclerosis
Registration Number
NCT02696590
Lead Sponsor
Isfahan University of Medical Sciences
Brief Summary

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.

Detailed Description

Ultraviolet sunlight is too low to produce adequate amounts of vitamin D3, and vitamin D insufficiency lasting 4 to 6 months of the year at latitudes of ≥42° is common in individuals with low vitamin D intake. Vitamin D has strong immunoregulatory effects, and vitamin D supplementation prevents experimental autoimmune encephalomyelitis (EAE), an autoimmune disease in animals that is used as a model of MS.

Recently, emerging data from epidemiologic studies suggest that vitamin D may play an important role in the progression of the development of MS. A longitudinal study in pediatric MS showed a 34% lower risk of relapse for every 10 ng/ml higher 25-hydroxyvitamin D level. A similar magnitude of reduced relapse risk was later reported in an adult MS cohort. Higher vitamin D levels have also been shown to be associated with less subsequent inflammatory MS activity on brain magnetic resonance imaging (MRI). Finally, studies have demonstrated that patients have lower vitamin D levels during MS relapses.

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
200
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

Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Primary Outcome Measures
NameTimeMethod
Serum concentration of 25(OH)DTwo Weeks
Secondary Outcome Measures
NameTimeMethod

Trial Locations

Locations (1)

Alzahra Hospital

🇮🇷

Isfahan, Iran, Islamic Republic of

Alzahra Hospital
🇮🇷Isfahan, Iran, Islamic Republic of

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