Solius UV Light Source in Improving Serum Levels of 25-hydroxyvitamin D

NCT ID: NCT04865432

Last Updated: 2022-12-23

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 10 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-08-24
• Study Completion Date: 2021-12-12

Brief Summary

This is a feasibility interventional study seeking to determine the safety and efficacy of the Solius Photobiologic System in increasing the serum levels of 25(OH)D in a vitamin D deficient/insufficient adult population.

Detailed Description

The investigators will conduct an interventional study to determine the changes in the changes in serum 25-hydroxyvitamin D levels between subjects who receive weekly exposures to Ultraviolet B Radiation (UVB) generated by the Solius Photobiological System for 4 weeks. Subjects 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 4-week study where they will be exposed to their individualized titration evaluation. Approximately 14 adult participants will be enrolled for serum 25-hydroxyvitamin D screening. The investigators expect to enroll 10 vitamin D-deficient or insufficient subjects in this study. Serum 25-hydroxyvitamin D levels will be measured prior to the first titration (week 2), prior to the intervention (week 6) and after the end of the study, and and the changes in serum 25-hydroxyvitamin D levels will be analyzed. The investigators expect that the levels will increase from the baseline.

Conditions

Vitamin D Deficiency; Vitamin D Insufficiency

Keywords

Vitamin D; Ultraviolet B radiation

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

UVB treatment

Participants 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, participants will participate in a 4-week intervention where they will be exposed to their individualized titration evaluation.

Group Type: EXPERIMENTAL

UVB treatment

Intervention Type: DEVICE

5 weeks of UVB titration to determine individual's UVB sensitivity followed by 4 weeks of UVB exposure intervention

Interventions

UVB treatment

5 weeks of UVB titration to determine individual's UVB sensitivity followed by 4 weeks of UVB exposure intervention

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

1. Age at least 22 years old

2. Male or Female

3. Skin Type I-VI

4. Women of childbearing 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

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

• Minimum Eligible Age: 22 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Boston University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Michael Holick, PhD MD

Role: PRINCIPAL_INVESTIGATOR

Boston University

Locations

General Clinical Research Unit (GCRU) BU School of Medicine

Boston, Massachusetts, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

H-41681

Identifier Type: -

Identifier Source: org_study_id