Comparing a Novel Phototherapy Kiosk to Oral Vitamin D Supplementation
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|ClinicalTrials.gov Identifier: NCT04556136|
Recruitment Status : Completed
First Posted : September 21, 2020
Last Update Posted : September 21, 2020
|Condition or disease||Intervention/treatment||Phase|
|Hypovitaminosis D||Device: Standing Phototherapy Kiosk Dietary Supplement: D3 Oral supplement||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||98 participants|
|Intervention Model:||Parallel Assignment|
|Intervention Model Description:||For volunteers assigned to the phototherapy kiosk, a measured dose of UVB was administered under conditions of full body exposure of 0.6 minimal erythemal dose (MED) every other week for 10 weeks. The stimulation of cutaneous vitamin D and subsequent 25(OH)D production from phototherapy was compared to the effect of a Recommended Daily Allowance (RDA) based dose of 600 IU vitamin D3 supplement daily for 10 weeks.|
|Masking:||Triple (Participant, Investigator, Outcomes Assessor)|
|Masking Description:||A computer-generated block design was created by an onsite biostatistician and used by the research pharmacist to randomize subjects. Once a subject met the inclusion criteria, the pharmacist was notified and she relayed the group assignment to the Project Coordinator. The study team had no knowledge of the group assignment in advance.|
|Official Title:||A Pilot Feasibility Study Comparing a Novel Phototherapy Kiosk to Supplementation to Promote Vitamin D Sufficiency|
|Actual Study Start Date :||April 30, 2018|
|Actual Primary Completion Date :||January 22, 2019|
|Actual Study Completion Date :||April 1, 2019|
Experimental: Standing Phototherapy Kiosk (SPK)
Volunteers assigned to this group were administered phototherapy treatments in a standing phototherapy kiosk once every other week, for 10 weeks. The treatment usually lasts no more than 10 minutes and is based on the Fitzpatrick skin type classification tool, which is self-reported via the computer touch screen in the kiosk.
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.
Other Name: Phototherapy Booth
Active Comparator: Oral Supplement
Volunteers assigned to this group were provided with a 10-week supply (70 pills) of a vitamin D3 supplement. Consented subjects were instructed to take one 600 IU pill by mouth each day for ten weeks. They were instructed to take this with a meal. This dose is the RDA for adults between 18 and 70 years old according to the Institute of Medicine Committee to Review Dietary Reference Intakes for Vitamin D and Calcium.
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.
Other Name: Vitamin D
- Serum vitamin D level [ Time Frame: Baseline ]25 Hydroxyvitamin D level in the blood
- Change from baseline serum vitamin D level [ Time Frame: 10 weeks ]25 Hydroxyvitamin D level in the blood
- Change from baseline serum vitamin D level [ Time Frame: 14 weeks ]25 Hydroxyvitamin D level in the blood
- Device acceptability using Device Usability Scale [ Time Frame: 14 weeks ]User satisfaction with the novel device
- Device feasibility [ Time Frame: 14 weeks ]Retention
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04556136
|United States, Washington|
|Madigan Army Medical Center|
|Tacoma, Washington, United States, 98431|
|Principal Investigator:||Mary S McCarthy, PhD||Nurse Scientist, CNSCI|