Multiple SclerosisNCT01994018
Correlation Between Relapses in Multiple Sclerosis (MS) and Vitamin D Intake
An observational study of Multiple Sclerosis, run by OSF Healthcare System at 1 site in United States.
Trial summary
The correlation between relapses in MS and vitamin D intake will be examined. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Multiple Sclerosis
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2011to Jun 2014
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: MS Group: Relapsing-remitting MS (RR-MS) patients according to the McDonald criteria who are treated with a FDA approved immuno-modulatory drugs. Control Group: Healthy individuals not on vitamin D supplementation.
Who may be able to join
- Ability to understand the purpose and risks of the study and provide signed and dated informed consent and authorization to use protected health information (PHI) in accordance with national and local subject privacy regulations.
- Be age 18 or older at the time of informed consent.
- Have a diagnosis of relapsing-remitting multiple sclerosis (RR-MS) as defined by the McDonald Criteria.
- Are taking FDA approved immune-modulatory drugs for MS.
- Patients had at least one relapse during the year prior to initiation of MS treatment.
- After at least 2 years on therapy, patients were classified as MS responders (MS-R) or MS non-responders (MS-NR) based on a clinical criteria recently reported in the literature. A responder (MS-R) is a patient with an annual relapse rate (ARR) < 0.5 and no evidence of disease progression as measured by EDSS (expanded disability status scale). A hypo/non-responder (MS-NR) is a patient with an ARR > 0.5 and/or with progression in the EDSS of at least 1 point sustained for 6 months.
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- Ability to understand the purpose and risks of the study and provide signed and dated informed consent and authorization to use protected health information (PHI) in accordance with national and local subject privacy regulations.
- Be age 18 or older at the time of informed consent.
- Have not taken any vitamin D supplementation for more than 12 months.
Who cannot join
- Those who have a diagnosis of secondary progressive MS (SPMS) or primary progressive MS (PPMS).
- Unwillingness or inability to comply with the requirements of this protocol, including the presence of any condition (physical, mental, or social) that is likely to affect the subject's ability to comply with the study protocol.
- Any other condition, clinical finding, or reason that, in the opinion of the Investigator, is determined to be unsuitable for enrollment into this study.
- Those who received other forms of treatment under than a FDA approved MS drugs are excluded.
- Unwillingness or inability to comply with the requirements of this protocol, including the presence of any condition (physical, mental, or social) that is likely to affect the subject's ability to comply with the study protocol.
- History of osteoporosis, kidney disease, parathyroid disease, problems with calcium metabolism, sacrcoidosis, and/or pregnancy.
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- Current nursing home or bed bound patients.
- Any other condition, clinical finding, or reason that, in the opinion of the Investigator, is determined to be unsuitable for enrollment into this study.
- Inclusion Criteria (Retrospective Chart Review) • Only RR-MS patients who received FDA approved immuno-modulatory drugs for MS.
- Patients diagnosed with MS sub-types other than RR-MS.
Trial locations and contacts
1 site in 1 country.
United States1 site
OSF Saint Francis Medical Center
Peoria, Illinois, 61637
About this study
The correlation between relapses in MS and vitamin D intake will be examined.
Read the detailed description
Research suggests that a connection between vitamin D and MS could be tied to the positive effects vitamin D has on the immune system. Published data also shows a synergistic effect of vitamin D in conjunction with Glatiramer acetate (GA), an already approved FDA immunomodulating drug, in the treatment of multiple sclerosis. Further correlation of vitamin D and GA or Interferon Beta needs to be tested.
This is a retrospective pilot study in which 100 patients diagnosed with relapsing-remitting MS (RR-MS) according to the McDonald criteria and treated with either GA or interferon with and without vitamin D supplementation for at least 2 years were included. Only RR-MS patients who received FDA approved immuno-modulatory drugs for MS are included in this review.
Relapses before and during treatment will be analyzed and a subgroup analysis will be done on those who received vitamin D and those who did not. Magnetic resonance Imaging (MRI) of the brain and cervical spine of these MS patients will also be reviewed to see if there is any correlation between radiologic changes, relapses and vitamin D level.
The 100 MS patients involved the chart review will be invited to participate in a one time blood draw to measure vitamin D levels. Additionally, the MS patients will be asked about their relapse status and medication history.
Twenty (20) healthy individuals not on vitamin D supplementation will be used as controls to get a baseline vitamin D level.
- Conditions
- Multiple Sclerosis
- Keywords
- Vitamin D, Interferon Beta, Glatiramer Acetate, Relapse rates
- Medical subject headings
- Multiple Sclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Control Group (Vitamin D level) | Twenty (20) healthy individuals not on vitamin D supplementation will be used as controls to get a baseline vitamin D level. | |
| MS Group | RR-MS patients treated with a FDA approved immuno-modulatory drug with and without vitamin D supplementation for at least 2 years. | |
| Retrospective Chart Review | RR-MS patients treated with a FDA approved immuno-modulatory drug for MS. |
What is being measured
The primary outcome is the main question the study is designed to answer.
• Annual relapse rates
Data collected from retrospective chart review part of study
Measured: After at least 2 years on therapy with an approved immuno-modulatory drug for MS.
Secondary outcomes (6)
Expanded Disability Status Scale
Data collected from retrospective chart review part of study.
Measured: After at least 2 years on therapy with an approved immuno-modulatory drug for MS.
Multiple Sclerosis Responders
Data collected from retrospective chart review part of study.
Measured: After at least 2 years on therapy with an approved immuno-modulatory drug for MS.
Multiple Sclerosis Non-Responders
Data collected from retrospective chart review part of study.
Measured: After at least 2 years on therapy with an approved immuno-modulatory drug for MS.
Response to immunodulators among patients who received MS treatment with or without vitamin D
Data collected from retrospective chart review part of study.
Measured: After at least 2 years on therapy with an approved immuno-modulatory drug for MS.
non-response to immunodulators among patients who received MS treatment with or without vitamin D
Data collected from retrospective chart review part of study.
Measured: After at least 2 years on therapy with an approved immuno-modulatory drug for MS.
MRI (brain images)
Data collected from retrospective chart review part of study.
Measured: after at least 2 years on therapy with an approved immuno-modulatory drug for MS.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Nov 2013 (estimated)
- Study startNov 2011
- Primary completionJun 2014
- Study completionJun 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Multiple SclerosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Other
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- OSF Healthcare System
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Reuben Valenzuela, OSF Healthcare System
- Investigators
- Reuben M Valenzuela, MD, Principal investigator, OSF Healthcare System
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01994018
- Sponsor's protocol ID
- OSF-13-002
- Status last verified
- Apr 2022
- First submitted
- 18 Oct 2013
- Last updated
- 29 Apr 2022
- Results posted
- No
- Data monitoring committee
- No
Publications
D'hooghe MB, Haentjens P, Nagels G, Garmyn M, De Keyser J. Sunlight exposure and sun sensitivity associated with disability progression in multiple sclerosis. Mult Scler. 2012 Apr;18(4):451-9. doi: 10.1177/1352458511423778. Epub 2011 Sep 27.
PubMed 21952096Smolders J, Moen SM, Damoiseaux J, Huitinga I, Holmoy T. Vitamin D in the healthy and inflamed central nervous system: access and function. J Neurol Sci. 2011 Dec 15;311(1-2):37-43. doi: 10.1016/j.jns.2011.07.033. Epub 2011 Aug 23.
PubMed 21862439O'Connor K, Weinstock-Guttman B, Carl E, Kilanowski C, Zivadinov R, Ramanathan M. Patterns of dietary and herbal supplement use by multiple sclerosis patients. J Neurol. 2012 Apr;259(4):637-44. doi: 10.1007/s00415-011-6226-3. Epub 2011 Sep 6.
PubMed 21898138Weinstock-Guttman B, Zivadinov R, Ramanathan M. Inter-dependence of vitamin D levels with serum lipid profiles in multiple sclerosis. J Neurol Sci. 2011 Dec 15;311(1-2):86-91. doi: 10.1016/j.jns.2011.07.024. Epub 2011 Aug 16.
PubMed 21849177McDowell TY, Amr S, Culpepper WJ, Langenberg P, Royal W, Bever C, Bradham DD. Sun exposure, vitamin D intake and progression to disability among veterans with progressive multiple sclerosis. Neuroepidemiology. 2011;37(1):52-7. doi: 10.1159/000329258. Epub 2011 Aug 5.
PubMed 21822026
Study at a glance
From the registry record, last updated by the sponsor on 29 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Correlation Between Relapses in Multiple Sclerosis (MS) and Vitamin D Intake
- ClinicalTrials.gov ID
- NCT01994018
- Acronym / sponsor ID
- OSF-13-002
- Conditions
- Multiple Sclerosis
- Keywords
- Vitamin D, Interferon Beta, Glatiramer Acetate, Relapse rates
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- OSF Healthcare SystemUniversity, hospital or other
- Study start
- Nov 2011
- Primary completion
- Jun 2014 (actual)
- Study completion
- Jun 2014 (actual)
- First posted
- 25 Nov 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The correlation between relapses in MS and vitamin D intake will be examined.
Detailed description
Research suggests that a connection between vitamin D and MS could be tied to the positive effects vitamin D has on the immune system. Published data also shows a synergistic effect of vitamin D in conjunction with Glatiramer acetate (GA), an already approved FDA immunomodulating drug, in the treatment of multiple sclerosis. Further correlation of vitamin D and GA or Interferon Beta needs to be tested.
This is a retrospective pilot study in which 100 patients diagnosed with relapsing-remitting MS (RR-MS) according to the McDonald criteria and treated with either GA or interferon with and without vitamin D supplementation for at least 2 years were included. Only RR-MS patients who received FDA approved immuno-modulatory drugs for MS are included in this review.
Relapses before and during treatment will be analyzed and a subgroup analysis will be done on those who received vitamin D and those who did not. Magnetic resonance Imaging (MRI) of the brain and cervical spine of these MS patients will also be reviewed to see if there is any correlation between radiologic changes, relapses and vitamin D level.
The 100 MS patients involved the chart review will be invited to participate in a one time blood draw to measure vitamin D levels. Additionally, the MS patients will be asked about their relapse status and medication history.
Twenty (20) healthy individuals not on vitamin D supplementation will be used as controls to get a baseline vitamin D level.
Study design
- Observational model
- Case-control
- Time perspective
- Other
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Control Group (Vitamin D level) | – | –Twenty (20) healthy individuals not on vitamin D supplementation will be used as controls to get a baseline vitamin D level. |
| MS Group | – | –RR-MS patients treated with a FDA approved immuno-modulatory drug with and without vitamin D supplementation for at least 2 years. |
| Retrospective Chart Review | – | –RR-MS patients treated with a FDA approved immuno-modulatory drug for MS. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- MS Group: Relapsing-remitting MS (RR-MS) patients according to the McDonald criteria who are treated with a FDA approved immuno-modulatory drugs. Control Group: Healthy individuals not on vitamin D supplementation.
Key inclusion criteria (9 listed)
- Ability to understand the purpose and risks of the study and provide signed and dated informed consent and authorization to use protected health information (PHI) in accordance with national and local subject privacy regulations.
- Be age 18 or older at the time of informed consent.
- Have not taken any vitamin D supplementation for more than 12 months.
Key exclusion criteria (10 listed)
- Unwillingness or inability to comply with the requirements of this protocol, including the presence of any condition (physical, mental, or social) that is likely to affect the subject's ability to comply with the study protocol.
- History of osteoporosis, kidney disease, parathyroid disease, problems with calcium metabolism, sacrcoidosis, and/or pregnancy.
- Current nursing home or bed bound patients.
- Any other condition, clinical finding, or reason that, in the opinion of the Investigator, is determined to be unsuitable for enrollment into this study.
- Inclusion Criteria (Retrospective Chart Review) • Only RR-MS patients who received FDA approved immuno-modulatory drugs for MS.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
• Annual relapse rates
Time frame: After at least 2 years on therapy with an approved immuno-modulatory drug for MS.
Data collected from retrospective chart review part of study
6 secondary outcomes
Expanded Disability Status Scale
Time frame: After at least 2 years on therapy with an approved immuno-modulatory drug for MS.
Multiple Sclerosis Responders
Time frame: After at least 2 years on therapy with an approved immuno-modulatory drug for MS.
Multiple Sclerosis Non-Responders
Time frame: After at least 2 years on therapy with an approved immuno-modulatory drug for MS.
Response to immunodulators among patients who received MS treatment with or without vitamin D
Time frame: After at least 2 years on therapy with an approved immuno-modulatory drug for MS.
non-response to immunodulators among patients who received MS treatment with or without vitamin D
Time frame: After at least 2 years on therapy with an approved immuno-modulatory drug for MS.
MRI (brain images)
Time frame: after at least 2 years on therapy with an approved immuno-modulatory drug for MS.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Apr 2022.
- Background: PubMed 21952096D'hooghe MB, Haentjens P, Nagels G, Garmyn M, De Keyser J. Sunlight exposure and sun sensitivity associated with disability progression in multiple sclerosis. Mult Scler. 2012 Apr;18(4):451-9. doi: 10.1177/1352458511423778. Epub 2011 Sep 27.
- Background: PubMed 21862439Smolders J, Moen SM, Damoiseaux J, Huitinga I, Holmoy T. Vitamin D in the healthy and inflamed central nervous system: access and function. J Neurol Sci. 2011 Dec 15;311(1-2):37-43. doi: 10.1016/j.jns.2011.07.033. Epub 2011 Aug 23.
- Background: PubMed 21898138O'Connor K, Weinstock-Guttman B, Carl E, Kilanowski C, Zivadinov R, Ramanathan M. Patterns of dietary and herbal supplement use by multiple sclerosis patients. J Neurol. 2012 Apr;259(4):637-44. doi: 10.1007/s00415-011-6226-3. Epub 2011 Sep 6.
- Background: PubMed 21849177Weinstock-Guttman B, Zivadinov R, Ramanathan M. Inter-dependence of vitamin D levels with serum lipid profiles in multiple sclerosis. J Neurol Sci. 2011 Dec 15;311(1-2):86-91. doi: 10.1016/j.jns.2011.07.024. Epub 2011 Aug 16.
- Background: PubMed 21822026McDowell TY, Amr S, Culpepper WJ, Langenberg P, Royal W, Bever C, Bradham DD. Sun exposure, vitamin D intake and progression to disability among veterans with progressive multiple sclerosis. Neuroepidemiology. 2011;37(1):52-7. doi: 10.1159/000329258. Epub 2011 Aug 5.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Reuben M Valenzuela, MD principal investigator
OSF Healthcare System
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Multiple Sclerosis, run by OSF Healthcare System at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
• Annual relapse rates (time frame: After at least 2 years on therapy with an approved immuno-modulatory drug for MS.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01994018, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Apr 2022.