Multiple SclerosisPhase 1NCT01024777
Safety and Immunologic Effect of Low Dose Versus High Dose Vitamin D3 in Multiple Sclerosis
A Phase 1 study testing Cholecalciferol in people with Multiple Sclerosis and Vitamin D Deficiency, run by Johns Hopkins University at 1 site in United States.
Trial summary
The purpose of this study is to determine the safety and the immunologic effects of supplementation with low-dose and high-dose cholecalciferol (vitamin D3) in patients with multiple sclerosis. Read more about this study
- Who is it for?
- Ages 18 to 55 years
- Conditions the study is for
- Multiple Sclerosis, Vitamin D Deficiency
- What is being tested?
- Cholecalciferol
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2010to Jan 2013
- Phase
- Phase 1
- 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 to 55 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Between ages of 18-55 years (inclusive)
- Serum 25(OH) vitamin D levels between 20-50 ng/mL and a candidate for vitamin D supplementation
- Patients with or without immunomodulatory therapy for RRMS
- Diagnosis of multiple sclerosis
Who cannot join
- Serum 25(OH) vitamin D deficient level < 20 ng/mL
- High dose vitamin D supplementation in the past 3 months
- Pregnancy
- History of tuberculosis, hyperparathyroidism, sarcoidosis or kidney stones
- Baseline serum creatinine above 1.5
- Hypersensitivity to vitamin D preparations
- Milk allergy
- Unable to consent
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Pilot Study to Assess the Relative Safety and Immunology Effects of Low Dose Versus High Dose Cholecalciferol Supplementation in Patients With Multiple Sclerosis
The purpose of this study is to determine the safety and the immunologic effects of supplementation with low-dose and high-dose cholecalciferol (vitamin D3) in patients with multiple sclerosis.
- Conditions
- Multiple Sclerosis, Vitamin D Deficiency
- Being tested
- Cholecalciferol
- Keywords
- cholecalciferol, multiple sclerosis, vitamin D, D3
- Medical subject headings
- Multiple Sclerosis, Vitamin D Deficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CholecalciferolDrug
Also called Vitamin D3
Cholecalciferol (Vitamin D3) 10,000 IU in tablet form will be taken once daily for the duration of the trial (6 months)
CholecalciferolDrug
Also called Vitamin D3
Cholecalciferol (Vitamin D3) 400 IU in tablet form will be taken once daily for the duration of the trial (6 months)
| Study group | Role | What they receive |
|---|---|---|
| High dose cholecalciferol | Active comparator | Patients in the high dose arm will receive 10,000 international units of cholecalciferol daily. Receives: Drug: Cholecalciferol |
| Low dose cholecalciferol | Active comparator | Patients enrolled in the low dose arm will receive up to 1000 international units of cholecalciferol daily. Receives: Drug: Cholecalciferol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assess safety of high dose cholecalciferol in patients with multiple sclerosis
Measured: 3-6 months
Assess the effects of cholecalciferol supplementation on serum immune markers in patients with multiple sclerosis
Measured: 3-6 months
Secondary outcomes (1)
Assess clinical effects of cholecalciferol supplementation in patients with multiple sclerosis
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Dec 2009 (estimated)
- Study startMar 2010
- Primary completionJan 2013
- Study completionJan 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Multiple SclerosisStudies 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 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Johns Hopkins University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Peter A. Calabresi, Johns Hopkins University
- Investigators
- Peter Calabresi, MD, Principal investigator, Johns Hopkins UniversityJohn Ratchford, MD, Principal investigator, Johns Hopkins University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01024777
- Sponsor's protocol ID
- NA_00023005
- Status last verified
- Feb 2013
- First submitted
- 2 Dec 2009
- Last updated
- 6 Feb 2013
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Feb 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Study to Assess the Relative Safety and Immunology Effects of Low Dose Versus High Dose Cholecalciferol Supplementation in Patients With Multiple Sclerosis
- ClinicalTrials.gov ID
- NCT01024777
- Acronym / sponsor ID
- NA_00023005
- Conditions
- Multiple Sclerosis, Vitamin D Deficiency
- Keywords
- cholecalciferol, multiple sclerosis, vitamin D, D3
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Johns Hopkins UniversityUniversity, hospital or other
- Study start
- Mar 2010
- Primary completion
- Jan 2013 (actual)
- Study completion
- Jan 2013 (actual)
- First posted
- 3 Dec 2009 (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 purpose of this study is to determine the safety and the immunologic effects of supplementation with low-dose and high-dose cholecalciferol (vitamin D3) in patients with multiple sclerosis.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| High dose cholecalciferol | Active comparator | Drug: CholecalciferolPatients in the high dose arm will receive 10,000 international units of cholecalciferol daily. |
| Low dose cholecalciferol | Active comparator | Drug: CholecalciferolPatients enrolled in the low dose arm will receive up to 1000 international units of cholecalciferol daily. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Between ages of 18-55 years (inclusive)
- Serum 25(OH) vitamin D levels between 20-50 ng/mL and a candidate for vitamin D supplementation
- Patients with or without immunomodulatory therapy for RRMS
- Diagnosis of multiple sclerosis
Key exclusion criteria (8 listed)
- Serum 25(OH) vitamin D deficient level < 20 ng/mL
- High dose vitamin D supplementation in the past 3 months
- Pregnancy
- History of tuberculosis, hyperparathyroidism, sarcoidosis or kidney stones
- Baseline serum creatinine above 1.5
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 |
|---|---|---|
| CholecalciferolAlso: Vitamin D3Cholecalciferol (Vitamin D3) 10,000 IU in tablet form will be taken once daily for the duration of the trial (6 months) | Drug | High dose cholecalciferol |
| CholecalciferolAlso: Vitamin D3Cholecalciferol (Vitamin D3) 400 IU in tablet form will be taken once daily for the duration of the trial (6 months) | Drug | Low dose cholecalciferol |
Primary outcome
Assess safety of high dose cholecalciferol in patients with multiple sclerosis
Time frame: 3-6 months
Assess the effects of cholecalciferol supplementation on serum immune markers in patients with multiple sclerosis
Time frame: 3-6 months
1 secondary outcome
Assess clinical effects of cholecalciferol supplementation in patients with multiple sclerosis
Time frame: 6 months
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 6 Feb 2013.
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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.
Peter Calabresi, MD principal investigator
Johns Hopkins University
John Ratchford, MD principal investigator
Johns Hopkins University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Cholecalciferol in people with Multiple Sclerosis and Vitamin D Deficiency, run by Johns Hopkins University 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 4 inclusion and 8 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 6 Feb 2013. 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.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Assess safety of high dose cholecalciferol in patients with multiple sclerosis (time frame: 3-6 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 6 Feb 2013.