Multiple SclerosisPhase 1NCT02365259
Phototherapy in Persons With Multiple Sclerosis
A Phase 1 study testing Phototherapy in people with Multiple Sclerosis, run by University of Illinois at Urbana-Champaign at 1 site in United States.
Trial summary
The current study examines the effect of phototherapy equipped with Narrow Band UVB lamps on vitamin D production in persons with MS. Read more about this study
- Who is it for?
- Ages 18 to 64 years, women only
- Conditions the study is for
- Multiple Sclerosis
- What is being tested?
- Phototherapy
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2015to Feb 2016
- 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 64 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Female with multiple sclerosis
Who cannot join
- Inability to stand still in a stabilized fashion without risk of falling for up to 6 minutes
- Known medical history of calcium disorder or knowledge of high calcium levels
- Known medical history of hyper-parathyroidism
- Current supplementation with oral vitamin D
- Known allergy to vitamin D
- History of cancer of any type including but not limited to skin cancer
Show all 12Show fewer
- Obesity defined as BMI > 30
- Known history of fat malabsorption conditions (i.e., steatorrhea)
- Current use of anti-epileptic medication
- Current use of glucocorticoids
- Fitzpatrick skin types I and VI using the Fitzpatrick skin type analysis
- Recent use of tanning facilities
Trial locations and contacts
1 site in 1 country.
United States1 site
Exercise Neuroscience Research Laboratory
Urbana, Illinois, 61801
About this study
Official title: Effect of UVB Phototherapy on Serum Vitamin D in Persons With Multiple Sclerosis; a Placebo Controlled Study
The current study examines the effect of phototherapy equipped with Narrow Band UVB lamps on vitamin D production in persons with MS.
Read the detailed description
Participants will be exposed to phototherapy according to the 2014 Guidelines issued by the American Academy of Dermatology 3 days per week over an 8-week period.
- Conditions
- Multiple Sclerosis
- Being tested
- Phototherapy
- Medical subject headings
- Multiple Sclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PhototherapyDevice
Participants will be exposed to phototherapy according to the 2014 Guidelines issued by the American Academy of Dermatology 3 days per week over an 8-week period.
| Study group | Role | What they receive |
|---|---|---|
| Phototherapy | Experimental | This arm involves exposure to a UVB phototherapy device 3 times per week over 8 weeks. Receives: Device: Phototherapy |
| Shame phototherapy | Placebo comparator | This arm is identical with experimental arm, except that participants will be exposed to non-UVB florescent light. Receives: Device: Phototherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from Baseline in Serum Vitamin D at 4 and 8 weeks
Venous blood will be collected to quantify levels of circulating Vitamin D.
Measured: 0, 4, and 8 weeks
Secondary outcomes (3)
Change from Baseline in Walking Speed at 4 and 8 weeks
Participants will walking for 25-feet as fast, but safely, as possible on an instrumented gait mat for measuring gait speed.
Measured: 0, 4, and 8 weeks
Change from Baseline in Cognitive Function at 4 and 8 weeks
Participants will complete neuropsychological assessments of processing speed and learning and memory.
Measured: 0, 4, and 8 weeks
Change from Baseline in Mood State at 4 and 8 weeks
Participants will complete a 30-item self-report measure of overall mood.
Measured: 0, 4, and 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Feb 2015 (estimated)
- Study startJan 2015
- Primary completionFeb 2016 (estimated)
- Study completionFeb 2016 (estimated)
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.
- 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
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Illinois at Urbana-Champaign
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Robert W Motl, PhD, Principal investigator, University of Illinois at Urbana-Champaign
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02365259
- Sponsor's protocol ID
- 15178
- Status last verified
- Feb 2015
- First submitted
- 2 Feb 2015
- Last updated
- 18 Feb 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Feb 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of UVB Phototherapy on Serum Vitamin D in Persons With Multiple Sclerosis; a Placebo Controlled Study
- ClinicalTrials.gov ID
- NCT02365259
- Acronym / sponsor ID
- 15178
- Conditions
- Multiple Sclerosis
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (actual)
- Lead sponsor
- University of Illinois at Urbana-ChampaignUniversity, hospital or other
- Study start
- Jan 2015
- Primary completion
- Feb 2016 (estimated)
- Study completion
- Feb 2016 (estimated)
- First posted
- 18 Feb 2015 (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 current study examines the effect of phototherapy equipped with Narrow Band UVB lamps on vitamin D production in persons with MS.
Detailed description
Participants will be exposed to phototherapy according to the 2014 Guidelines issued by the American Academy of Dermatology 3 days per week over an 8-week period.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Phototherapy | Experimental | Device: PhototherapyThis arm involves exposure to a UVB phototherapy device 3 times per week over 8 weeks. |
| Shame phototherapy | Placebo comparator | Device: PhototherapyThis arm is identical with experimental arm, except that participants will be exposed to non-UVB florescent light. |
Who may qualify
- Ages
- 18 to 64 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Female with multiple sclerosis
Key exclusion criteria (12 listed)
- Inability to stand still in a stabilized fashion without risk of falling for up to 6 minutes
- Known medical history of calcium disorder or knowledge of high calcium levels
- Known medical history of hyper-parathyroidism
- Current supplementation with oral vitamin D
- Known allergy to vitamin D
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 |
|---|---|---|
| PhototherapyParticipants will be exposed to phototherapy according to the 2014 Guidelines issued by the American Academy of Dermatology 3 days per week over an 8-week period. | Device | Phototherapy, Shame phototherapy |
Primary outcome
Change from Baseline in Serum Vitamin D at 4 and 8 weeks
Time frame: 0, 4, and 8 weeks
Venous blood will be collected to quantify levels of circulating Vitamin D.
3 secondary outcomes
Change from Baseline in Walking Speed at 4 and 8 weeks
Time frame: 0, 4, and 8 weeks
Change from Baseline in Cognitive Function at 4 and 8 weeks
Time frame: 0, 4, and 8 weeks
Change from Baseline in Mood State at 4 and 8 weeks
Time frame: 0, 4, and 8 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Feb 2015.
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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.
Robert W Motl, PhD principal investigator
University of Illinois at Urbana-Champaign
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 Phototherapy in people with Multiple Sclerosis, run by University of Illinois at Urbana-Champaign 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 1 inclusion and 12 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: status not confirmed, as of the sponsor's last update on 18 Feb 2015. 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. Some participants in this study may receive a placebo. 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?
Results are not available in the source record.
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 from Baseline in Serum Vitamin D at 4 and 8 weeks (time frame: 0, 4, and 8 weeks). 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 18 Feb 2015.