Comparing a Novel Phototherapy Kiosk to Oral Vitamin D Supplementation

Not Applicable

Completed

Conditions: Hypovitaminosis D

Interventions: Dietary Supplement: D3 Oral supplement
Device: Standing Phototherapy Kiosk

Registration Number: NCT04556136

Lead Sponsor: Madigan Army Medical Center

Brief 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.

Detailed Description: The proposed pilot study uses a prospective, longitudinal, randomized design with repeated measures to address vitamin D sufficiency in Active Duty (AD), retiree, beneficiary, and Department of Army civilian populations. It is important and necessary to conduct this study with adult humans, military personnel in particular, to determine acceptability and feasibility of this phototherapy kiosk as an addition to existing Warfighter resources to promote health and resilience. Anticipating 20% attrition, approximately 120 volunteers will be recruited from Madigan Army Medical Center and Joint Base Lewis-McChord (JBLM), a large joint base in the Pacific Northwest, where over 25,000 Soldiers and Airmen train every day and regional beneficiaries number \~98,000. Recruiting efforts will attempt to capture a representative sample of the population including genders, diverse ethnicities, and a range of age (18-70 years) and body mass index, who have no contraindication for Ultraviolet (UV) B exposure or oral vitamin D supplementation. Using a computer-generated block design, volunteers will be randomized to one of two treatment groups; 1) oral vitamin D supplementation, or 2) standing phototherapy kiosk (SPK) with UVB exposure, for a 10 week period.

Group 1- Supplement: A Madigan Army Medical Center (MAMC) Research Pharmacist will dispense a 10-week supply of the vitamin D3 600 International Units (IU) oral supplement to subjects assigned to this group one time. The Project Coordinator will work with the pharmacist to coordinate pick-up of supplement bottles for subjects or optimal in-person dispensing times.

Group 2 - SPK: The Project Coordinator will oversee the phototherapy treatment. Spectrum isolation modules in the kiosk will deliver the UVB dose under supervised conditions over a 2-5 minute interval based on the Fitzpatrick skin type category with the subject wearing minimal or no clothing, preferably no more than a bathing suit and protective eye-wear. The experience in the SPK is designed to be comfortable.

We will enroll all eligible adult volunteers regardless of their baseline 25(OH)D level; it is important to show there is no potential for harm from phototherapy, even if the baseline 25(OH)D level is above 30 ng/mL. We also must learn the trajectory of vitamin D absorption and availability over a 3-4 month period in order to make evidence-based therapeutic recommendations. It is not possible to blind the subjects or research team to the group assignment. Serum levels of 25(OH)D, calcium, and parathyroid hormone will be drawn at baseline (T0), and immediately following the intervention at 10 weeks (T6); at 14 weeks (T8), 25(OH) D will be drawn to document sustainment of treatment effect. A survey will be completed at T1 to capture relevant demographic, medical history, sun exposure, travel, daily activities, and dietary data. Active duty participants will also report the number of days on profile for the previous three months, at T1 and T6. A survey regarding Device Usability will be administered upon kiosk protocol completion. We will analyze data using repeated measures analysis of variance adjusting for significant covariates such as 25(OH)D level at baseline. Logistic regression analyses will be used to predict outcomes and explain the interrelationships among variables, i.e. age, gender, body fat, BMI, ethnicity, and sun exposure relationship to 25(OH)D serum levels.

Outcomes:

1. Serum 25(OH)D level. This primary outcome will be crucial to establishing whether the device, a standing phototherapy kiosk (SPK), is equivalent to oral vitamin D3 supplementation which is currently the standard of care prescribed by licensed providers to address vitamin D insufficiency/deficiency. We will establish a baseline 25(OH)D level for both study arms.

2. Change in serum 25(OH)D at 10 weeks to reflect adequacy of SPK and supplement treatment.

3. Change in serum 25(OH)D at 14 weeks will evaluate sustainment of the post-SPK treatment level.

4. Device acceptability by Device Usability Scale. To properly evaluate the outcome of acceptability of this demonstration project involving two arms, one an SPK and the other an oral vitamin D supplement, the research team will administer the Device Usability Scale upon study completion at 14 weeks.

5. Device feasibility will be assessed by meticulously tracking of the number of potential participants screened, the number of enrolled subjects, and attrition from each arm. Reasons for attrition will be documented following a discussion with the subject, if possible.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 106

Inclusion Criteria

Adults, age 18 - 69 years
Ability to read and understand English
Subjectively in good health
Able to stand without assistance for ~10 minutes

Exclusion Criteria

Any volunteer with relocation, deployment, or release from active duty in the next 4 months
Pregnant, or currently breastfeeding, females
Anyone with chronic health problems (e.g. kidney disease, liver disease, intestinal malabsorption)
Any volunteer currently taking vitamin D supplementation
Taking medications for an endocrine disorder, such as Synthroid or oral hypoglycemic agents
Sarcoidosis
Medications having a high potential for interaction with vitamin D:

anti-seizure medications, cyclosporine, indinavir (Crixivan) • Adults diagnosed with light allergies: Actinic prurigo, Polymorphous light eruption, Solar urticaria

• Adults diagnosed with light sensitivities: Protoporphyria, Photodermatitis, Xeroderma pigmentosum, Lupus erythematosus, Actinic dermatitis, UV-sensitive syndrome

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Oral Supplement	D3 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.
Standing Phototherapy Kiosk (SPK)	Standing Phototherapy Kiosk	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.

Primary Outcome Measures

Name	Time	Method
Serum Vitamin D Level	10 weeks	25 Hydroxyvitamin D level in the blood
Change in Serum Vitamin D Level From Baseline to Week 14	Baseline and 14 weeks	Change over time in 25(OH)D from baseline to week 14 in kiosk group versus supplement group.
Percentage of Participants With Adherence	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.

Secondary Outcome Measures

Name	Time	Method
Device Acceptability Using Device Usability Scale	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.
Number of Subjects Retained at 14 Weeks	Baseline to 14 weeks	We examined the number of subjects remaining at 14 weeks.