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UV Light Source
UVB treatment for Vitamin D Deficiency
N/A
Waitlist Available
Led By Michael F Holick, MD PhD
Research Sponsored by Boston University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up week 1, week 21
Summary
This trial is testing a special light system called the Solius Photobiological System to see if it can help adults with low vitamin D levels. The system uses UVB light to help the skin make more vitamin D. The study will observe the effects of this light treatment over several months.
Eligible Conditions
- Vitamin D Deficiency
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ week 1, week 21
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~week 1, week 21
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Change in Serum 25-Hydroxyvitamin D [25(OH)D]
Distribution of Participants by Vitamin D Deficiency Categories at Week 1
Distribution of Participants by Vitamin D Deficiency Categories at Week 21
Trial Design
2Treatment groups
Experimental Treatment
Placebo Group
Group I: UVB treatment armExperimental Treatment1 Intervention
The treatment group will first undergo an evaluation of each individual's sensitivity to the SOLIUS System UVB using the device titration system for the first 5 weeks. Once the UVB dose is determined during the 5 weeks, the subjects will be enrolled in a 16-week study where they will be exposed to their individualized dose.
Group II: Sham comparator armPlacebo Group1 Intervention
The sham comparator group will undergo the procedures as the treatment group with the exception that the SOLIUS System will only be turned on to emit visible radiation.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
UVB treatment
2011
Completed Phase 3
~110
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Who is running the clinical trial?
Boston UniversityLead Sponsor
472 Previous Clinical Trials
9,987,757 Total Patients Enrolled
8 Trials studying Vitamin D Deficiency
1,093 Patients Enrolled for Vitamin D Deficiency
Michael F Holick, MD PhDPrincipal InvestigatorBoston University
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Eligibility Criteria:
This trial includes the following eligibility criteria:- Anyone can participate regardless of gender.Your skin type falls within the range of Type I-VI.You have taken medication for allergies called H1 antihistamines in the past week.You take more than 600 International Units (IU) of vitamin D supplements every day.You have a past diagnosis of skin cancer.You have been diagnosed with a condition that makes you sensitive to light, such as protoporphyria, photodermatitis, xeroderma pigmentosum, lupus erythematosus, chronic actinic dermatitis, or UV-sensitive syndrome.You have used a tanning bed or received phototherapy treatment in the past month.You are currently pregnant.You have mild allergic reactions to sunlight, such as itchy skin, rashes, or hives.You have a history of being overly sensitive to sunlight.You are taking medications that make your skin sensitive to sunlight, such as tetracycline, doxycycline, and hydrochlorothiazide.You plan to be in areas with strong sunlight below the 33rd parallel during the study.You are currently taking steroids for a medical condition.
Research Study Groups:
This trial has the following groups:- Group 1: Sham comparator arm
- Group 2: UVB treatment arm
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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