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

NCT04780776 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 69

Last updated 2024-10-22

Study results available
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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

Interventions

DEVICE

UVB treatment

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

DEVICE

Sham comparator

5+16 weeks of visible light exposure

Sponsors & Collaborators

  • Boston University

    lead OTHER

Principal Investigators

  • Michael F Holick, MD PhD · Boston University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
22 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2022-02-23
Primary Completion
2023-11-02
Completion
2023-11-02
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04780776 on ClinicalTrials.gov