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

Primary Purpose

Vitamin D Deficiency, Vitamin D Insufficiency

Status

Completed

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

UVB treatment

About this trial

This is an interventional treatment trial for Vitamin D Deficiency focused on measuring Vitamin D, Ultraviolet B radiation

Eligibility Criteria

22 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

Age at least 22 years old
Male or Female
Skin Type I-VI
Women of childbearing potential must be on birth control and not pregnant based on a negative pregnancy test at baseline.
Ability and Willingness to give informed consent and comply to protocol requirements
Serum total 25(OH)D < 30 ng/mL

Exclusion Criteria:

Ongoing treatment with supplemental or pharmacological doses of vitamin D, vitamin D metabolites or analogues
Pregnant
History of underlying photosensitivity
Use of medications that cause a photosensitivity reaction (including but not limited to): tetracycline, tretinoin, amiodarone, doxycycline, naproxen, diphenhydramine, methotrexate, and hydrochlorothiazide
History of skin cancer
Plan to received significant sun exposure below the 33rd parallel during study
Used tanning or phototherapy devices within the last 30 days
Vitamin D supplement use of more than 600 IUs daily.
Systemic steroids use
H1 antihistamine use in the last 7 days
Diagnosed with light allergies (including but not limited to): actinic prurigo, polymorphous light eruption, or solar urticaria
Diagnosed with light sensitivities (including but not limited to): protoporphyria, photodermatitis, xeroderma pigmentosum, lupus erythematosus, chronic actinic dermatitis, or UV-sensitive syndrome

Sites / Locations

General Clinical Research Unit (GCRU) BU School of Medicine

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

UVB treatment

Arm Description

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.

Outcomes

Primary Outcome Measures

Serum 25-hydroxyvitamin D

Serum 25-hydroxyvitamin D level at 4 weeks of intervention (the end of study)

Secondary Outcome Measures

Full Information

NCT ID

NCT04865432

First Posted

April 26, 2021

Last Updated

December 2, 2022

Sponsor

Boston University

1. Study Identification

Unique Protocol Identification Number

NCT04865432

Brief Title

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

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: A Feasibility Study

Study Type

Interventional

2. Study Status

Record Verification Date

December 2022

Overall Recruitment Status

Completed

Study Start Date

August 24, 2021 (Actual)

Primary Completion Date

December 12, 2021 (Actual)

Study Completion Date

December 12, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Boston University

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Yes

Product Manufactured in and Exported from the U.S.

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Vitamin D Deficiency, Vitamin D Insufficiency

Keywords

Vitamin D, Ultraviolet B radiation

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

10 (Actual)

8. Arms, Groups, and Interventions

Arm Title

UVB treatment

Arm Type

Experimental

Arm Description

Intervention Type

Device

Intervention Name(s)

UVB treatment

Intervention Description

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

Primary Outcome Measure Information:

Title

Serum 25-hydroxyvitamin D

Description

Serum 25-hydroxyvitamin D level at 4 weeks of intervention (the end of study)

Time Frame

Serum 25-hydroxyvitamin D at 4 weeks of intervention

10. Eligibility

Sex

All

Minimum Age & Unit of Time

22 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Age at least 22 years old Male or Female Skin Type I-VI Women of childbearing potential must be on birth control and not pregnant based on a negative pregnancy test at baseline. Ability and Willingness to give informed consent and comply to protocol requirements Serum total 25(OH)D < 30 ng/mL Exclusion Criteria: Ongoing treatment with supplemental or pharmacological doses of vitamin D, vitamin D metabolites or analogues Pregnant History of underlying photosensitivity Use of medications that cause a photosensitivity reaction (including but not limited to): tetracycline, tretinoin, amiodarone, doxycycline, naproxen, diphenhydramine, methotrexate, and hydrochlorothiazide History of skin cancer Plan to received significant sun exposure below the 33rd parallel during study Used tanning or phototherapy devices within the last 30 days Vitamin D supplement use of more than 600 IUs daily. Systemic steroids use H1 antihistamine use in the last 7 days Diagnosed with light allergies (including but not limited to): actinic prurigo, polymorphous light eruption, or solar urticaria Diagnosed with light sensitivities (including but not limited to): protoporphyria, photodermatitis, xeroderma pigmentosum, lupus erythematosus, chronic actinic dermatitis, or UV-sensitive syndrome

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Michael Holick, PhD MD

Organizational Affiliation

Boston University

Official's Role

Principal Investigator

Facility Information:

Facility Name

General Clinical Research Unit (GCRU) BU School of Medicine

City

Boston

State/Province

Massachusetts

ZIP/Postal Code

02118

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

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

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