Evaluating the Effect of Solius UV Light Source in Improving Vitamin D Status

• Sponsor: Boston University (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT04780776
• Collaborator: (none)
• Enrollment: 100
• Location: 1
• Arms: 2
• Anticipated Duration (Months): 7.2
• Patients Per Site Per Month: 13.8

Study Details

Study Description

Brief Summary

The aim of this study is to evaluate the safety and effectiveness of the Solius Photobiological System in improving serum levels of 25-hydroxyvitamin D in vitamin D deficient/ insufficient adults of various skin types.

The invetigators will conduct an double-blinded randomized clinical trial in 100 adults to compare the changes in serum 25-hydroxyvitamin D levels between subjects who received and do not receive weekly exposures to Ultraviolet B Radiation (UVB) generated by the Solius Photobiological System for 16 weeks.

Condition or Disease	Intervention/Treatment	Phase
Vitamin D Deficiency; Vitamin D Insufficiency	Device: UVB treatment; Device: Sham comparator	N/A

Detailed Description

Study enrollment

Approximately 100 healthy adults will be enrolled ages >18; both sexes, for vitamin D deficiency screening in order to enroll 80 adults with vitamin D deficiency/insufficiency (serum 25-hydroxyvitamin D <30 ng/mL). Participants will be randomized 1:1 into two groups: 40 adults for treatment arm who will receive weekly exposures of ultraviolet radiation generated by the Solius Photobiological system, and 40 adults for sham comparator arm.

Study procedure

The treatment group that will be exposed to the Solius Photobiological System will first undergo an evaluation of each individual's sensitivity to the Solius Photobiological System UVB using the device titration system for the first 5 weeks. Once determined after the 5 weeks, the subjects will be enrolled in a 16-week study where they will be exposed to their individualized titration evaluation. For the sham comparator group, they will undergo the procedures as the treated group with the exception that the Solius Photobiological System will only be turned on to emit visible radiation. At these visits, each subject assigned into both groups will be asked questions about consumption of vitamin D, sun exposure, and whether he/she has had any adverse changes in his/her health. Serum 25-hydroxyvitamin D levels will be measured at baseline and monthly, and the levels will be analyzed to compare between those who receive and who do not receive the UVB radiation intervention for baseline and during the 16-week treatment period. After the 16-week intervention, participants will be asked to return the study site weekly for measurement of serum 25-hydroxyvitamin D for 4 weeks. Serum 25(OH)D levels will be determined using the Liquid Chromatography with tandem mass spectrometry (LC/MS/MS) method. Safety will be monitored by interviewing the participants each UVB exposure for any adverse events, including erythema or any other skin reactions.

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 100 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Triple (Participant, Care Provider, Investigator)
• Primary Purpose: Treatment
• Official Title: Evaluating the Effect of Solius UV Light Source in Improving Serum Levels of 25-hydroxyvitamin D in Vitamin D Deficient/ Insufficient Adults of Various Skin Types
• Actual Study Start Date: Feb 23, 2022
• Anticipated Primary Completion Date: Oct 1, 2022
• Anticipated Study Completion Date: Oct 1, 2022

Arms and Interventions

Arm	Intervention/Treatment
Experimental: UVB treatment arm The treatment group will first undergo an evaluation of each individual's sensitivity to the Solius Photobiological System UVB using the device titration system for the first 5 weeks. Once determined after the 5 weeks, the subjects will be enrolled in a 16-week study where they will be exposed to their individualized titration evaluation.	Device: UVB treatment; 5 weeks of UVB titration to determine individual's UVB sensitivity followed by 16 weeks of UVB exposure intervention
Sham Comparator: Sham comparator arm The sham comparator group will undergo the procedures as the treatment group with the exception that the Solius Photobiological System will only be turned on to emit visible radiation.	Device: Sham comparator; 5+16 weeks of visible light exposure

Outcome Measures

Primary Outcome Measures

1. Baseline serum 25-hydroxyvitamin D [Baseline]

2. Serum 25-hydroxyvitamin D at 4 weeks of intervention [Week 4 of the intervention]

3. Serum 25-hydroxyvitamin D at 8 weeks of intervention [Week 8 of the intervention]

4. Serum 25-hydroxyvitamin D at 12 weeks of intervention [Week 12 of the intervention]

5. Serum 25-hydroxyvitamin D at 16 weeks of intervention [Week 16 of the intervention]

6. Serum 25-hydroxyvitamin D at 1 week post-intervention [Week 1 post-intervention]

7. Serum 25-hydroxyvitamin D at 2 weeks post-intervention [Week 2 post-intervention]

8. Serum 25-hydroxyvitamin D at 3 weeks post-intervention [Week 3 post-intervention]

9. Serum 25-hydroxyvitamin D at 4 weeks post-intervention [Week 4 post-intervention]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Inclusion Criteria:

1. Age at least 18 years' old

2. Male or Female

3. Skin Type I-VI

4. Women of child bearing potential must be on birth control and not pregnant based on a negative pregnancy test at baseline.

5. Ability and Willingness to give informed consent and comply to protocol requirements

6. Serum total 25(OH)D < 30 ng/mL at the screening

Exclusion Criteria:

1. Ongoing treatment with supplemental or pharmacological doses of vitamin D, vitamin D metabolites or analogues

2. Pregnant

3. History of underlying photosensitivity

4. Use of medications that cause a photosensitivity reaction (including but not limited to): tetracycline, tretinoin, amiodarone, doxycycline, naproxen, diphenhydramine, methotrexate, and hydrochlorothiazide

5. History of skin cancer

6. Plan to received significant sun exposure below the 33rd parallel during study

7. Used tanning or phototherapy devices within the last 30 days

8. Vitamin D supplement use of more than 600 IUs daily.

9. Systemic steroids use

10. H1 antihistamine use in the last 7 days

11. Diagnosed with light allergies (including but not limited to): actinic prurigo, polymorphous light eruption, or solar urticaria

12. Diagnosed with light sensitivities (including but not limited to): protoporphyria, photodermatitis, xeroderma pigmentosum, lupus erythematosus, chronic actinic dermatitis, or UV-sensitive syndrome

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	BU School of Medicine	Boston	Massachusetts	United States	02118

Sponsors and Collaborators

• Boston University

Investigators

• Principal Investigator: Michael F Holick, MD PhD, Boston University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Boston University
• ClinicalTrials.gov Identifier: NCT04780776
• Other Study ID Numbers: H-40850
• First Posted: Mar 4, 2021
• Last Update Posted: Mar 29, 2022
• Last Verified: Mar 1, 2022

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Product Manufactured in and Exported from the U.S.: Yes
• Keywords provided by Boston University: Vitamin D; Ultraviolet B radiation
• Additional relevant MeSH terms: Vitamin D Deficiency

Study Results

No Results Posted as of Mar 29, 2022