Multiple Sclerosis, Relapsing-remittingNCT01667796
Pharmacokinetics of Vitamin D in Multiple Sclerosis and in Health
A study testing Vitamin D3 in people with Multiple Sclerosis, Relapsing-remitting, run by Johns Hopkins University at 2 sites in United States.
Trial summary
This is a pilot study of oral vitamin D supplementation to determine if patients with Multiple Sclerosis (MS) and healthy individuals attain a similar increase in serum 25-hydroxyvitamin D levels. Read more about this study
- Who is it for?
- Ages 18 to 60 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Multiple Sclerosis, Relapsing-remitting
- What is being tested?
- Vitamin D3
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 57 participants
- Where
- 2 sitesUnited States
- Study dates
- Nov 2010to Mar 2014
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 to 60 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Female
- Healthy or multiple sclerosis
- Aged 18 to 60
- Body mass index is between 18 kg/m2 and 30 kg/m2
- Screening 25-hydroxyvitamin D level ≤ 75 nmol/L (30 ng/mL)
- White race
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- Non-Hispanic ethnicity
- Willing to use birth control during study
- Willing to not use tanning bed during study
- If subject has multiple sclerosis:
- Relapsing-remitting MS, as defined by McDonald 2005 criteria
- Screening Expanded Disability Status Scale score ≤ 3.0
- Using no medication for MS, or taking Copaxone, (glatiramer acetate), interferons, or natalizumab
Who cannot join
- Pregnant or nursing
- Taking multivitamin \& unwilling to remain off it during study
- Taking cod liver oil \& unwilling to remain off it during study
- On a fat-restricted diet
- History of renal disease or nephrolithiasis (kidney stones)
- History of liver disease
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- Taking thiazide diuretics
- History of hyperthyroidism
- History of infection with Mycobacterium species
- History of sarcoidosis
- History of cancer
- History of cardiac disease
- History of HIV
- History of gastrointestinal disorder
- Taking medications that interfere with gastrointestinal absorption
- Cigarette smoker in past month
- Use of illicit drugs in past month
- Use of steroids in past month
- History of hypercalcemia, and screening serum calcium ≤ 10 mg/dL (UCSF) or ≤ 10.7 mg/dL (Johns Hopkins)
- History of hypercalciuria
- Evidence of anemia (Hgb <11.0 g/dL)
- History of other serious medical conditions
- Taking medications that involve the P450 system or may interact with vitamin D (digoxin, diltiazem, verapamil, cimetidine, heparin, or low-molecular weight heparin)
- Other concerns about safety from the perspective of the treating physician
- If subject has MS:
- -History of major heat sensitivity (leading to sun-avoidant behaviors)
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Johns Hopkins University
Baltimore, Maryland, 21287
University of California, San Francisco
San Francisco, California, 94143
About this study
Official title: Pharmacodynamic and Immunologic Effects of Vitamin D Supplementation in Patients With Multiple Sclerosis and Healthy Controls
This is a pilot study of oral vitamin D supplementation to determine if patients with Multiple Sclerosis (MS) and healthy individuals attain a similar increase in serum 25-hydroxyvitamin D levels. The investigators will also assess whether the immunologic or relevant gene expression response to oral vitamin D supplementation differs in patients with MS and healthy controls.
- Conditions
- Multiple Sclerosis, Relapsing-remitting
- Being tested
- Vitamin D3
- Keywords
- Multiple sclerosis, Healthy controls, Pharmacokinetics, Vitamin D
- Medical subject headings
- Multiple Sclerosis, Relapsing-Remitting, Multiple Sclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vitamin D3Dietary supplement
| Study group | Role | What they receive |
|---|---|---|
| Vitamin D3 | Experimental | Both those with MS and healthy controls will be given vitamin D3 5000 IU/day by mouth for 90 days. Receives: Dietary Supplement: Vitamin D3 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Mean Serum Level of 25-hydroxyvitamin D
Generalized estimating equations (GEE) with an autoregressive with lag one correlation matrix were used to compare the serially-measured serum 25(OH)D levels between MS patients and Healthy Controls (HCs) to take into account repeated measures and within-subject correlations.
Measured: Baseline to 90 days
Secondary outcomes (4)
Change in Percentages of T Cell Subsets (IFNγ+ and IL-17+)
Analyzed the mean percentage change in IFNγ+ and IL-17+ cluster of differentiation 4 (CD4) + cells (post- versus pre- supplementation). This represents a change between two time points (90 days versus baseline).
Measured: Baseline, 90 days
Gene Expression Microarray
We had initially planned to do whole blood gene expression. The experience gained by the laboratory that was to perform this since the original trial was planned was that this measure is too noisy and would not yield meaningful results. Thus, this analysis will no longer be conducted.
Measured: 90 days
Change in Cytokine Levels
The original plan had been to measure the change in basic serum cytokine levels (e.g. IL-17, interferon gamma; IL-10; pg/microliter). However, due to emerging data suggesting low utility of these measures, this plan was abandoned.
Measured: 90 days
Change in Percentage of B Cells
The change in percentage (day 90-baseline) was originally planned for study. Due to the limited number of patients with samples this plan was abandoned.
Measured: 90 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Aug 2012 (estimated)
- Study startNov 2010
- Primary completionMar 2014
- Study completionMar 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Multiple Sclerosis, Relapsing-remittingStudies of the same condition, open and under way.
- More trials run by Johns Hopkins UniversityThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 57 participants (actual)
Sponsor and investigators
- Lead sponsor
- Johns Hopkins University
- Sponsor type
- University, hospital or other
- Collaborators
- University of California, San Francisco, National Multiple Sclerosis Society
- Responsible party
- Sponsor
- Investigators
- Ellen M Mowry, MD, MCR, Principal investigator, Johns Hopkins University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01667796
- Sponsor's protocol ID
- NA_00049428
- Other IDs
- FG-1507-05231
- Status last verified
- Mar 2019
- First submitted
- 13 Aug 2012
- Last updated
- 5 Mar 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
Bhargava P, Fitzgerald KC, Calabresi PA, Mowry EM. Metabolic alterations in multiple sclerosis and the impact of vitamin D supplementation. JCI Insight. 2017 Oct 5;2(19):e95302. doi: 10.1172/jci.insight.95302.
PubMed 28978801
Study at a glance
From the registry record, last updated by the sponsor on 5 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pharmacodynamic and Immunologic Effects of Vitamin D Supplementation in Patients With Multiple Sclerosis and Healthy Controls
- ClinicalTrials.gov ID
- NCT01667796
- Acronym / sponsor ID
- NA_00049428
- Conditions
- Multiple Sclerosis, Relapsing-remitting
- Keywords
- Multiple sclerosis, Healthy controls, Pharmacokinetics, Vitamin D
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 57 participants (actual)
- Lead sponsor
- Johns Hopkins UniversityUniversity, hospital or other
- Collaborators
- University of California, San Francisco, National Multiple Sclerosis Society
- Study start
- Nov 2010
- Primary completion
- Mar 2014 (actual)
- Study completion
- Mar 2014 (actual)
- First posted
- 17 Aug 2012 (estimated)
- Results
- Posted 1 Feb 2016
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a pilot study of oral vitamin D supplementation to determine if patients with Multiple Sclerosis (MS) and healthy individuals attain a similar increase in serum 25-hydroxyvitamin D levels. The investigators will also assess whether the immunologic or relevant gene expression response to oral vitamin D supplementation differs in patients with MS and healthy controls.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Vitamin D3 | Experimental | Dietary Supplement: Vitamin D3Both those with MS and healthy controls will be given vitamin D3 5000 IU/day by mouth for 90 days. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (13 listed)
- Female
- Healthy or multiple sclerosis
- Aged 18 to 60
- Body mass index is between 18 kg/m2 and 30 kg/m2
- Screening 25-hydroxyvitamin D level ≤ 75 nmol/L (30 ng/mL)
Key exclusion criteria (26 listed)
- Pregnant or nursing
- Taking multivitamin \& unwilling to remain off it during study
- Taking cod liver oil \& unwilling to remain off it during study
- On a fat-restricted diet
- History of renal disease or nephrolithiasis (kidney stones)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Vitamin D3 | Dietary supplement | Vitamin D3 |
Primary outcome
Change in Mean Serum Level of 25-hydroxyvitamin D
Time frame: Baseline to 90 days
Generalized estimating equations (GEE) with an autoregressive with lag one correlation matrix were used to compare the serially-measured serum 25(OH)D levels between MS patients and Healthy Controls (HCs) to take into account repeated measures and within-subject correlations.
4 secondary outcomes
Change in Percentages of T Cell Subsets (IFNγ+ and IL-17+)
Time frame: Baseline, 90 days
Gene Expression Microarray
Time frame: 90 days
Change in Cytokine Levels
Time frame: 90 days
Change in Percentage of B Cells
Time frame: 90 days
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Mar 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 28978801Bhargava P, Fitzgerald KC, Calabresi PA, Mowry EM. Metabolic alterations in multiple sclerosis and the impact of vitamin D supplementation. JCI Insight. 2017 Oct 5;2(19):e95302. doi: 10.1172/jci.insight.95302.
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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.
Ellen M Mowry, MD, MCR principal investigator
Johns Hopkins University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Vitamin D3 in people with Multiple Sclerosis, Relapsing-remitting, run by Johns Hopkins University at 2 sites 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 13 inclusion and 26 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 5 Mar 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
Yes. Results are posted in the registry (first posted 1 Feb 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Change in Mean Serum Level of 25-hydroxyvitamin D (time frame: Baseline to 90 days). 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 NCT01667796, which also lists 1 linked publication.
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 5 Mar 2019.