Vitamin D Supplementation in Multiple Sclerosis
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| ClinicalTrials.gov Identifier: NCT01490502 |
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Recruitment Status :
Completed
First Posted : December 13, 2011
Results First Posted : September 28, 2022
Last Update Posted : September 28, 2022
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Sponsor:
Johns Hopkins University
Collaborators:
Oregon Health and Science University
University of California, San Francisco
Washington University School of Medicine
Icahn School of Medicine at Mount Sinai
University of Pennsylvania
Yale University
The Cleveland Clinic
University of Rochester
Stanford University
University of Virginia
Swedish Medical Center
Anne Arundel Health System Research Institute
Columbia University
University of Massachusetts, Worcester
Dignity Health
Information provided by (Responsible Party):
Johns Hopkins University
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| Study Type | Interventional |
|---|---|
| Study Design | Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor); Primary Purpose: Treatment |
| Condition |
Relapsing Remitting Multiple Sclerosis |
| Intervention |
Drug: Vitamin D3 |
| Enrollment | 172 |
Participant Flow
| Recruitment Details | Recruitment took place from March 2012 through April 2019 at 16 neurology clinics in the United States. |
| Pre-assignment Details | After successful screening, a thirty day run-in period was used to assess compliance with daily subcutaneous glatiramer acetate injections. Participants who missed more than 3 injections during the run-in period were ineligible to be randomized and were withdrawn from further study participation. |
| Arm/Group Title | Low-dose Vitamin D3 | High-dose Vitamin D3 |
|---|---|---|
 Arm/Group Description |
Vitamin D3: Patients will be assigned to low dose (600 IU/day) versus high-dose (5000 IU/day) of vitamin D3 as an add-on therapy to glatiramer acetate (Copaxone). | Vitamin D3: Patients will be assigned to low dose (600 IU/day) versus high-dose (5000 IU/day) of vitamin D3 as an add-on therapy to glatiramer acetate (Copaxone). |
| Period Title: Overall Study | ||
| Started | 83 | 89 |
| Received Allocated Intervention | 83 | 88 |
| Attended at Least 1 Follow-up Visit | 82 | 83 |
| Completed | 68 | 72 |
| Not Completed | 15 | 17 |
Baseline Characteristics
| Arm/Group Title | Low-dose Vitamin D3 | High-dose Vitamin D3 | Total | |
|---|---|---|---|---|
|
Arm/Group Description |
Vitamin D3: Patients will be assigned to low dose (600 IU/day) versus high-dose (5000 IU/day) of vitamin D3 as an add-on therapy to glatiramer acetate (Copaxone). | Vitamin D3: Patients will be assigned to low dose (600 IU/day) versus high-dose (5000 IU/day) of vitamin D3 as an add-on therapy to glatiramer acetate (Copaxone). | Total of all reporting groups | |
| Overall Number of Baseline Participants | 83 | 89 | 172 | |
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Baseline Analysis Population Description |
[Not Specified]
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Age, Continuous
Mean (Standard Deviation) Unit of measure: Years |
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| Number Analyzed | 83 participants | 89 participants | 172 participants | |
| 34.2 (7.7) | 34.5 (7.1) | 34.4 (7.4) | ||
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Sex: Female, Male
Measure Type: Count of Participants Unit of measure: Participants |
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| Number Analyzed | 83 participants | 89 participants | 172 participants | |
| Female |
70 84.3%
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61 68.5%
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131 76.2%
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| Male |
13 15.7%
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28 31.5%
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41 23.8%
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Ethnicity (NIH/OMB)
Measure Type: Count of Participants Unit of measure: Participants |
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| Number Analyzed | 83 participants | 89 participants | 172 participants | |
| Hispanic or Latino |
12 14.5%
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18 20.2%
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30 17.4%
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| Not Hispanic or Latino |
70 84.3%
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71 79.8%
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141 82.0%
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| Unknown or Not Reported |
1 1.2%
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0 0.0%
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1 0.6%
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Race (NIH/OMB)
Measure Type: Count of Participants Unit of measure: Participants |
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| Number Analyzed | 83 participants | 89 participants | 172 participants | |
| American Indian or Alaska Native |
0 0.0%
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0 0.0%
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0 0.0%
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| Asian |
1 1.2%
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1 1.1%
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2 1.2%
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| Native Hawaiian or Other Pacific Islander |
0 0.0%
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0 0.0%
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0 0.0%
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| Black or African American |
18 21.7%
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11 12.4%
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29 16.9%
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| White |
61 73.5%
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71 79.8%
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132 76.7%
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| More than one race |
0 0.0%
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1 1.1%
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1 0.6%
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| Unknown or Not Reported |
3 3.6%
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5 5.6%
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8 4.7%
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Region of Enrollment
Measure Type: Count of Participants Unit of measure: Participants |
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| United States | Number Analyzed | 83 participants | 89 participants | 172 participants |
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83 100.0%
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89 100.0%
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172 100.0%
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Expanded Disability Status Scale (EDSS) score
[1] [2] Median (Inter-Quartile Range) Unit of measure: Units on a scale |
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| Number Analyzed | 83 participants | 89 participants | 172 participants | |
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2.00
(1.00 to 2.50)
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2.00
(1.50 to 2.50)
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2.00
(1.38 to 2.50)
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[1]
Measure Description: The Expanded Disability Status Scale (EDSS) is an ordinal clinical rating scale based on a standard neurological examination and is used to measure global neurologic impairment in people with multiple sclerosis (MS). It ranges from a minimum of 0.0 (normal examination) to 10.0 (death due to MS) in half-point increments.
[2]
Measure Analysis Population Description: Screening EDSS was used for one high-dose vitamin D3 participant with missing EDSS at baseline.
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Multiple Sclerosis Functional Composite (MSFC) score
[1] Mean (Standard Deviation) Unit of measure: Z-score |
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| Number Analyzed | 83 participants | 89 participants | 172 participants | |
| 0.5 (0.4) | 0.6 (0.5) | 0.5 (0.4) | ||
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[1]
Measure Description: The Multiple Sclerosis Functional Composite (MSFC) is a three-part measure of disability for people with multiple sclerosis, including measures of leg function/ambulation, arm/hand function and cognitive function. The three independent measures have different units. We take the reciprocal of the arm/hand function test, and then convert all measures to Z-scores. The average of the Z-scores from each measure yields the MSFC composite Z-score. A Z-score of 0 represents the population mean and positive scores indicate less disability.
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Low-contrast acuity
[1] Mean (Standard Deviation) Unit of measure: Letters |
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| Number Analyzed | 83 participants | 89 participants | 172 participants | |
| 36 (10) | 34 (10) | 35 (10) | ||
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[1]
Measure Description: Low-contrast acuity was measured as binocular vision on a 2.5% Sloan chart at a distance of 2 meters. The chart is used to test the ability to discriminate gradually smaller gray letters with a 2.5% contrast level against a white background. The low-contrast acuity measure is scored as total letters read and ranges from 0 (no letters read) to 60 (all letters read), with higher scores indicating better low-contrast acuity.
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Health-related Quality of Life
[1] Mean (Standard Deviation) Unit of measure: Units on a scale |
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| Number Analyzed | 83 participants | 89 participants | 172 participants | |
| 126 (24) | 126 (27) | 126 (26) | ||
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[1]
Measure Description: The Functional Assessment of Multiple Sclerosis (FAMS) is the quality of life (QOL) instrument used in this trial. It consists of 44 questions and the total score has a possible range of 0 to 176, with higher scores indicating better QOL.
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Normalized Brain Parenchymal Volume
[1] Mean (Standard Deviation) Unit of measure: Microliters |
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| Number Analyzed | 74 participants | 82 participants | 156 participants | |
| 1,488,270 (107,046) | 1,496,147 (88,025) | 1,492,411 (97,270) | ||
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[1]
Measure Analysis Population Description: Baseline Brain MRI not available or not of sufficient quality to compute measure for 9 low-dose vitamin D3 and 7 high-dose vitamin D3 participants.
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Normalized Gray Matter Volume
[1] Median (Inter-Quartile Range) Unit of measure: Microliters |
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| Number Analyzed | 74 participants | 82 participants | 156 participants | |
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772,736
(735,433 to 809,191)
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781,461
(737,843 to 807,965)
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774,469
(736,684 to 808,542)
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[1]
Measure Analysis Population Description: Baseline Brain MRI not available or not of sufficient quality to compute measure for 9 low-dose vitamin D3 and 7 high-dose vitamin D3 participants.
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Outcome Measures
Adverse Events
Limitations and Caveats
[Not Specified]
More Information
Results Point of Contact
| Name/Title: | Sandra D. Cassard, ScD |
| Organization: | The Johns Hopkins University School of Medicine |
| Phone: | 443-287-4353 |
| EMail: | scassar1@jhmi.edu |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Johns Hopkins University |
| ClinicalTrials.gov Identifier: | NCT01490502 |
| Other Study ID Numbers: |
NA_00049137 |
| First Submitted: | December 6, 2011 |
| First Posted: | December 13, 2011 |
| Results First Submitted: | May 13, 2022 |
| Results First Posted: | September 28, 2022 |
| Last Update Posted: | September 28, 2022 |