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

Primary Purpose

Relapsing Remitting Multiple Sclerosis

Status
Completed
Phase
Not Applicable
Locations
Iran, Islamic Republic of
Study Type
Interventional
Intervention
Vitamin D3
Sponsored by
Isfahan University of Medical Sciences
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Relapsing Remitting Multiple Sclerosis

Eligibility Criteria

23 Years - 59 Years (Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Alzahra Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Active Comparator

Active Comparator

Arm Label

MS patients injectable Vitamin D3

MS patients orally Vitamin D3

Healthy groups Injectable Vitamin D3

Healthy groups Vitamin D3 orally

Arm Description

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

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.

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

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.

Outcomes

Primary Outcome Measures

Serum concentration of 25(OH)D

Secondary Outcome Measures

Full Information

First Posted
February 18, 2016
Last Updated
March 1, 2016
Sponsor
Isfahan University of Medical Sciences
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1. Study Identification

Unique Protocol Identification Number
NCT02696590
Brief Title
High Dose Oral Versus Intramuscular Vitamin D3 Supplementation In Multiple Sclerosis Patients
Official Title
Isfahan University of Medical Sciences
Study Type
Interventional

2. Study Status

Record Verification Date
February 2016
Overall Recruitment Status
Completed
Study Start Date
July 2015 (undefined)
Primary Completion Date
November 2015 (Actual)
Study Completion Date
December 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Isfahan University of Medical Sciences

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Relapsing Remitting Multiple Sclerosis

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
200 (Actual)

8. Arms, Groups, and Interventions

Arm Title
MS patients injectable Vitamin D3
Arm Type
Experimental
Arm Description
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
Arm Title
MS patients orally Vitamin D3
Arm Type
Experimental
Arm Description
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.
Arm Title
Healthy groups Injectable Vitamin D3
Arm Type
Active Comparator
Arm Description
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
Arm Title
Healthy groups Vitamin D3 orally
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Dietary Supplement
Intervention Name(s)
Vitamin D3
Other Intervention Name(s)
cholecalciferol
Intervention Description
two forms of vitamin D3 (Oral versus injection) were compared in MS and healthy groups.
Primary Outcome Measure Information:
Title
Serum concentration of 25(OH)D
Time Frame
Two Weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
23 Years
Maximum Age & Unit of Time
59 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Masoud Etemadifar, professor
Organizational Affiliation
Isfahan MS Society, Isfahan University of Medical Sciences, Isfahan, Iran
Official's Role
Study Director
Facility Information:
Facility Name
Alzahra Hospital
City
Isfahan
ZIP/Postal Code
81745319
Country
Iran, Islamic Republic of

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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

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