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

Isfahan University of Medical Sciences

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.

Study Overview

• Status: Completed
• Conditions: Relapsing Remitting Multiple Sclerosis
• Intervention / Treatment: Dietary supplement: Vitamin D3

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.

• Study Type: Interventional
• Enrollment (Actual): 200
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Iran, Islamic Republic of
  • Isfahan, Iran, Islamic Republic of, 81745319
    • Alzahra Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 23 years to 59 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: MS patients injectable Vitamin D3; MS patients who received injectable form of Vitamin D3, received 600.000 IU Intramuscular vitamin D3 injection, in two weeks; 300.000 IU at the study entry and 300.000 IU in second week	Dietary supplement: Vitamin D3; two forms of vitamin D3 (Oral versus injection) were compared in MS and healthy groups.; Other Names: cholecalciferol
Experimental: MS patients orally Vitamin D3; received the same total dose of 600 000 IU D3 in two weeks, in the form of twelve pearls, each containing 50 000 IU D3 as follows: the first pearl was delivered at study entry, followed by one pearl each day for another 11 Days.	Dietary supplement: Vitamin D3; two forms of vitamin D3 (Oral versus injection) were compared in MS and healthy groups.; Other Names: cholecalciferol
Active Comparator: Healthy groups Injectable Vitamin D3; who received injectable form of Vitamin D3, received 600.000 IU Intramuscular vitamin D3 injection, in two weeks; 300.000 IU at the study entry and 300.000 IU in second week	Dietary supplement: Vitamin D3; two forms of vitamin D3 (Oral versus injection) were compared in MS and healthy groups.; Other Names: cholecalciferol
Active Comparator: Healthy groups Vitamin D3 orally; received the same total dose of 600 000 IU D3 in two weeks, in the form of twelve pearls, each containing 50 000 IU D3 as follows: the first pearl was delivered at study entry, followed by one pearl each day for another 11 Days.	Dietary supplement: Vitamin D3; two forms of vitamin D3 (Oral versus injection) were compared in MS and healthy groups.; Other Names: cholecalciferol

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Serum concentration of 25(OH)D	Two Weeks

Collaborators and Investigators

• Sponsor: Isfahan University of Medical Sciences
• Investigators: Study Director: Masoud Etemadifar, professor, Isfahan MS Society, Isfahan University of Medical Sciences, Isfahan, Iran

Study record dates

Study Major Dates

• Study Start: July 1, 2015
• Primary Completion (Actual): November 1, 2015
• Study Completion (Actual): December 1, 2015

Study Registration Dates

• First Submitted: February 18, 2016
• First Submitted That Met QC Criteria: March 1, 2016
• First Posted (Estimate): March 2, 2016

Study Record Updates

• Last Update Posted (Estimate): March 2, 2016
• Last Update Submitted That Met QC Criteria: March 1, 2016
• Last Verified: February 1, 2016

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Nervous System Diseases; Immune System Diseases; Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Demyelinating Diseases; Autoimmune Diseases; Multiple Sclerosis; Sclerosis; Multiple Sclerosis, Relapsing-Remitting; Physiological Effects of Drugs; Micronutrients; Vitamins; Bone Density Conservation Agents; Calcium-Regulating Hormones and Agents; Vitamin D; Cholecalciferol
• Other Study ID Numbers: Isfahan MS Society

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED