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

NCT04865432 | Completed Results FDA Device

• 1 other identifier: H-41681
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

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.

Conditions

Vitamin D Deficiency; Vitamin D Insufficiency

Keywords

Vitamin D; Ultraviolet B radiation

Outcome Measures

Primary Outcomes (1)

• Serum 25-hydroxyvitamin D

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

  Serum 25-hydroxyvitamin D at 4 weeks of intervention

Study Arms (1)

UVB treatment

EXPERIMENTAL

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.

Device: UVB treatment

Interventions

UVB treatment DEVICE

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

UVB treatment

Eligibility Criteria

• Age: 22 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Boston University: lead

Study Sites (1)

General Clinical Research Unit (GCRU) BU School of Medicine

Boston, Massachusetts, 02118, United States

Location

MeSH Terms

Conditions

Vitamin D Deficiency

Condition Hierarchy (Ancestors)

Avitaminosis; Deficiency Diseases; Malnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases

Results Point of Contact

• Title: Michael F. Holick PhD, MD
• Organization: Boston University Chobanian & Avedisian School of Medicine

mfholick@bu.edu

617-358-6139

Study Officials

• Michael Holick, PhD MD

  Boston University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 26, 2021
• First Posted: April 29, 2021
• Study Start: August 24, 2021
• Primary Completion: December 12, 2021
• Study Completion: December 12, 2021
• Last Updated: December 23, 2022
• Results First Posted: December 23, 2022

Record last verified: 2022-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)