Comparing a Novel Phototherapy Kiosk to Oral Vitamin D Supplementation
Condition: Hypovitaminosis D
MeSH terms: Rickets; Avitaminosis; Vitamin D Deficiency
Study type: Interventional

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.
    

Intervention name(s): Standing Phototherapy Kiosk; D3 Oral supplement
Intervention type(s): Device; Dietary Supplement
Intervention description(s): 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.; 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 intervention name(s): Phototherapy Booth; Vitamin D
Intervention MeSH terms: Vitamin D
Allocation: Randomized
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)
Primary purpose: Treatment
Keywords: VitaminD; UVBPhototherapy; Military