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

Relapsing Remitting Multiple Sclerosis Clinical Trial

Official title:

Isfahan University of Medical Sciences

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02696590
• Other study ID #: Isfahan MS Society
• Status: Completed
• Phase: N/A
• First received: February 18, 2016
• Last updated: March 1, 2016
• Start date: July 2015
• Est. completion date: December 2015

Study information

• 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

Clinical Trial 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.

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 information / eligibility

• 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

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Multiple Sclerosis
• Multiple Sclerosis, Relapsing-Remitting
• Relapsing Remitting Multiple Sclerosis
• Sclerosis

Intervention

Dietary Supplement:
• Vitamin D3
two forms of vitamin D3 (Oral versus injection) were compared in MS and healthy groups.

Locations

Country	Name	City	State
Iran, Islamic Republic of	Alzahra Hospital	Isfahan

Sponsors (1)

Lead Sponsor	Collaborator
Isfahan University of Medical Sciences

Country where clinical trial is conducted

Iran, Islamic Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Serum concentration of 25(OH)D		Two Weeks	Yes