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Comparing a Novel Phototherapy Kiosk to Oral Vitamin D Supplementation

NCT04556136 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 106

Last updated 2024-03-13

Study results available
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Summary

The purpose of this project is to demonstrate the capability of a standing phototherapy kiosk (SPK) to stimulate cutaneous vitamin D3 and subsequent production of 25 Hydroxyvitamin (OH) D safely and as efficiently as an oral vitamin D3 supplement of 600 IU taken daily over a 10 week intervention period. We will conduct a randomized controlled trial with two treatment arms; \~120 volunteers will be assigned to either the SPK or to a 600 IU daily oral vitamin D3 supplement for 10 weeks. The SPK is an innovative, networked, self-care technology that stimulates endogenous vitamin D production with two \~2-minute treatments per month. It will be tested in an ambulatory setting where enrolled/assigned participants of various baseline levels of 25(OH)D will present for a treatment dose, based on Fitzpatrick skin type category, every other week for 10 weeks. The SPK does not produce a cosmetic tan or dispense pills.

Conditions

  • Hypovitaminosis D

Interventions

DEVICE

Standing Phototherapy Kiosk

Benesol is a freestanding booth designed to deliver a small amount of targeted UVB with an interactive user interface and cloud-based software that enables patient self-care. The treatment delivery mechanism uses a metal halide lamp with a series of filters and a lens to optimize full-body exposure to the narrow spectrum (293 - 303nm) of UVB light most efficient at producing vitamin D3. The device uses software to identify patients, establish individual skin types and determine dosage. The system has been designed to manage exposure time and frequency and deliver 60% of a skin-type-adjusted Minimal Erythemal Dose (MED). The expected result for users is a rise in blood levels of 25(OH)D via the endogenous pathway.

DIETARY_SUPPLEMENT

D3 Oral supplement

Each subject assigned to the comparison group was instructed to take one vitamin D3 pill, dispensed by the research pharmacist, each day with a meal for 70 days. Subjects were instructed not to take any additional vitamin D supplementation during the study period. This dosing frequency is consistent with the RDA recommendation. Subjects were instructed to bring their pill bottle with them when returning for their follow up appointment.

Sponsors & Collaborators

  • Madigan Army Medical Center

    lead FED

Principal Investigators

  • Mary S McCarthy, PhD · Nurse Scientist, CNSCI

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
69 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2018-04-30
Primary Completion
2019-01-22
Completion
2019-04-01
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 NCT04556136 on ClinicalTrials.gov