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

NCT04780776 | Completed Results FDA Device

• 1 other identifier: H-40850
• Study Type: interventional
• Target: 69
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of this study is to evaluate the safety and effectiveness of the SOLIUS System in improving serum levels of 25-hydroxyvitamin D in vitamin D deficient/ insufficient adults of various skin types. The investigators will conduct a 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 System for 16 weeks.

Conditions

Vitamin D Deficiency; Vitamin D Insufficiency

Keywords

Vitamin D; Ultraviolet B radiation; SOLIUS System

Outcome Measures

Primary Outcomes (3)

• Change in Serum 25-Hydroxyvitamin D [25(OH)D]

  This outcome measures the change in serum 25-hydroxyvitamin D \[25(OH)D\] concentrations in participants from Week 1 to the end of the intervention period Week 21.

  Week 1, Week 21

• Distribution of Participants by Vitamin D Deficiency Categories at Week 1

  The three vitamin D categories are defined as: Deficient - \<20 ng/mL 25(OH)D, Insufficient - 21-29 ng/mL 25(OH)D, Sufficient - 30-100 ng/mL 25(OH)D.

  Week 1

• Distribution of Participants by Vitamin D Deficiency Categories at Week 21

  The three vitamin D categories are defined as: Deficient - \<20 ng/mL 25(OH)D, Insufficient - 21-29 ng/mL 25(OH)D, Sufficient - 30-100 ng/mL 25(OH)D.

  Week 21

Study Arms (2)

UVB treatment arm

EXPERIMENTAL

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.

Device: UVB treatment

Sham comparator arm

SHAM COMPARATOR

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.

Device: Sham comparator

Interventions

UVB treatment DEVICE

5 weeks of UVB titration to determine individual's UVB sensitivity followed by 16 weeks of UVB exposure intervention

UVB treatment arm

Sham comparator DEVICE

5+16 weeks of visible light exposure

Sham comparator arm

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 child bearing 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 at the screening

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)

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: Dr. Michael F. Holick
• Organization: Boston University School of Medicine

mfholick@bu.edu

(617) 358-6139

Study Officials

• Michael F Holick, MD PhD

  Boston University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 26, 2021
• First Posted: March 4, 2021
• Study Start: February 23, 2022
• Primary Completion: November 2, 2023
• Study Completion: November 2, 2023
• Last Updated: October 22, 2024
• Results First Posted: October 22, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)