NCT04556136

Comparing a Novel Phototherapy Kiosk to Oral Vitamin D Supplementation

Completed NA Results posted Last updated 13 March 2024

What this trial tests

NA trial testing Standing Phototherapy Kiosk in Hypovitaminosis D in 106 participants. Completed in 1 April 2019.

Timeline

30 April 2018

Primary endpoint
22 January 2019

1 April 2019

Quick facts

Lead sponsor	Madigan Army Medical Center
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	triple
Primary purpose	treatment
Enrollment	106
Start date	30 April 2018
Primary completion	22 January 2019
Estimated completion	1 April 2019
Sites	1 location across United States

Drugs / interventions tested

• Standing Phototherapy Kiosk
• D3 Oral supplement

Conditions studied

• Hypovitaminosis D — all drugs for Hypovitaminosis D →

Sponsor

Madigan Army Medical Center

Who can join

Adults 18 to 69, any sex, with Hypovitaminosis D. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Serum Vitamin D Level Primary · 10 weeks

25 Hydroxyvitamin D level in the blood

Group	Value	95% CI
Standing Phototherapy Kiosk (SPK)	30.0	25.8 – 37.0
Oral Supplement	25.5	21.0 – 29.8

Change in Serum Vitamin D Level From Baseline to Week 14 Primary · Baseline and 14 weeks

Change over time in 25(OH)D from baseline to week 14 in kiosk group versus supplement group.

Group	Value	95% CI
Standing Phototherapy Kiosk (SPK)	27	22.0 – 32.5
Oral Supplement	21	17.0 – 30.0

Percentage of Participants With Adherence Primary · 10 weeks

Percentage of participants with adherence to daily supplement, and Percentage of phototherapy treatments received. Adherence to daily supplement was calculated as the percentage of participants who consumed all 70 pills. Adherence to phototherapy treatments was calculated as the percentage of participants who received all 6 treatments according to protocol.

Group	Value	95% CI
Standing Phototherapy Kiosk (SPK)	98
Oral Supplement	98

Device Acceptability Using Device Usability Scale Secondary · 14 weeks

User acceptability and satisfaction with the novel kiosk on the Device Usability Scale (DUS), also referred to as System Usability Scale. The DUS was administered to the SPK Group upon completion of the study to assess user acceptability of the intervention. This 12-item Likert-type scale assessed cleanliness, ease of use, and comfort of the kiosk with a Likert-type scale where 1= Strongly disagree to 5 = Strongly agree. Minimum score = 12, maximum score = 60. Higher scores indicate greater acceptability and satisfaction with the device.

Group	Value	95% CI
Standing Phototherapy Kiosk (SPK)	55.38	± 4.33

Number of Subjects Retained at 14 Weeks Secondary · Baseline to 14 weeks

We examined the number of subjects remaining at 14 weeks.

Group	Value	95% CI
Standing Phototherapy Kiosk (SPK)	39
Oral Supplement	41

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.