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Completed

NCT Number: NCT04865432

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

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.

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Key information

Age range

22 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

General Clinical Research Unit (GCRU) BU School of Medicine

Boston, Massachusetts, 02118, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

UVB treatment

Device

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

Primary outcomes

  1. Serum 25-hydroxyvitamin D

    Time frame: Serum 25-hydroxyvitamin D at 4 weeks of intervention

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

Sponsors and collaborators

Lead sponsor

Boston University

Other

Registry information

Official study 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

Important dates

Study start
2021
Primary completion
2021
Study completion
2021
First posted
Apr 29, 2021
Registry last updated
Dec 23, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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