Comparing a Novel Phototherapy Kiosk to Oral Vitamin D Supplementation

Hypovitaminosis D Clinical Trial

Official title:

A Pilot Feasibility Study Comparing a Novel Phototherapy Kiosk to Supplementation to Promote Vitamin D Sufficiency

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04556136
• Other study ID #: 217121
• Status: Completed
• Phase: N/A
• Start date: April 30, 2018
• Est. completion date: April 1, 2019

Study information

• Verified date: March 2024
• Source: Madigan Army Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 106
• Est. completion date: April 1, 2019
• Est. primary completion date: January 22, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 69 Years

Eligibility

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

Related Conditions & MeSH terms

• Avitaminosis
• Hypovitaminosis D
• Rickets
• Vitamin D Deficiency

Intervention

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.

Locations

Country	Name	City	State
United States	Madigan Army Medical Center	Tacoma	Washington

Sponsors (1)

Lead Sponsor	Collaborator
Madigan Army Medical Center

Country where clinical trial is conducted

United States, 

References & Publications (6)

Bogh MK, Schmedes AV, Philipsen PA, Thieden E, Wulf HC. A small suberythemal ultraviolet B dose every second week is sufficient to maintain summer vitamin D levels: a randomized controlled trial. Br J Dermatol. 2012 Feb;166(2):430-3. doi: 10.1111/j.1365-2133.2011.10697.x. — View Citation

Chen TC, Chimeh F, Lu Z, Mathieu J, Person KS, Zhang A, Kohn N, Martinello S, Berkowitz R, Holick MF. Factors that influence the cutaneous synthesis and dietary sources of vitamin D. Arch Biochem Biophys. 2007 Apr 15;460(2):213-7. doi: 10.1016/j.abb.2006.12.017. Epub 2007 Jan 8. — View Citation

Fitzpatrick TB. The validity and practicality of sun-reactive skin types I through VI. Arch Dermatol. 1988 Jun;124(6):869-71. doi: 10.1001/archderm.124.6.869. No abstract available. — View Citation

He CS, Aw Yong XH, Walsh NP, Gleeson M. Is there an optimal vitamin D status for immunity in athletes and military personnel? Exerc Immunol Rev. 2016;22:42-64. — View Citation

Holick MF, Binkley NC, Bischoff-Ferrari HA, Gordon CM, Hanley DA, Heaney RP, Murad MH, Weaver CM; Endocrine Society. Evaluation, treatment, and prevention of vitamin D deficiency: an Endocrine Society clinical practice guideline. J Clin Endocrinol Metab. 2011 Jul;96(7):1911-30. doi: 10.1210/jc.2011-0385. Epub 2011 Jun 6. Erratum In: J Clin Endocrinol Metab. 2011 Dec;96(12):3908. — View Citation

Koutkia P, Lu Z, Chen TC, Holick MF. Treatment of vitamin D deficiency due to Crohn's disease with tanning bed ultraviolet B radiation. Gastroenterology. 2001 Dec;121(6):1485-8. doi: 10.1053/gast.2001.29686. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Serum Vitamin D Level	25 Hydroxyvitamin D level in the blood	10 weeks
Primary	Change in Serum Vitamin D Level From Baseline to Week 14	Change over time in 25(OH)D from baseline to week 14 in kiosk group versus supplement group.	Baseline and 14 weeks
Primary	Percentage of Participants With Adherence	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.	10 weeks
Secondary	Device Acceptability Using Device Usability Scale	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.	14 weeks
Secondary	Number of Subjects Retained at 14 Weeks	We examined the number of subjects remaining at 14 weeks.	Baseline to 14 weeks