Comparing a Novel Phototherapy Kiosk to Oral Vitamin D Supplementation

NCT04556136 | Completed Results FDA Device

• 1 other identifier: 217121
• Study Type: interventional
• Target: 106
• Locations: 1 country
• Sites: 1

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.

Conditions

Hypovitaminosis D

Keywords

VitaminD; UVBPhototherapy; Military

Outcome Measures

Primary Outcomes (3)

• Serum Vitamin D Level

  25 Hydroxyvitamin D level in the blood

  10 weeks

• 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

• 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 Outcomes (2)

• Device Acceptability Using Device Usability Scale

  14 weeks

• Number of Subjects Retained at 14 Weeks

  Baseline to 14 weeks

Study Arms (2)

Standing Phototherapy Kiosk (SPK)

EXPERIMENTAL

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

Oral Supplement

ACTIVE COMPARATOR

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

Interventions

Standing Phototherapy Kiosk DEVICE

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.

Also known as: Phototherapy Booth

Standing Phototherapy Kiosk (SPK)

D3 Oral supplement DIETARY_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.

Also known as: Vitamin D

Oral Supplement

Eligibility Criteria

• Age: 18 Years - 69 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Madigan Army Medical Center: lead

Study Sites (1)

Madigan Army Medical Center

Tacoma, Washington, 98431, United States

Location

Related Publications (6)

• 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.

  PMID: 11729127 BACKGROUND

• 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.

  PMID: 26853300 BACKGROUND

• 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.

  PMID: 21646368 BACKGROUND

• 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.

  PMID: 17254541 BACKGROUND

• 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.

  PMID: 3377516 BACKGROUND

• 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.

  PMID: 22013924 BACKGROUND

MeSH Terms

Conditions

Vitamin D Deficiency

Interventions

Vitamin D

Condition Hierarchy (Ancestors)

Avitaminosis; Deficiency Diseases; Malnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Secosteroids; Steroids; Fused-Ring Compounds; Polycyclic Compounds

Limitations and Caveats

Due to the use of an untested device, the appropriate sample size was estimated based on previous and current vitamin D studies, involving an adult population, and a similar approach to vitamin D supplementation. Study conducted at a single center in a geographic location known for limited opportunity for exposure to UVB as a source for vitamin D therefore low vitamin D status is common. Results may not be generalizable to adults in communities throughout the US.

Results Point of Contact

• Title: Dr. Mary McCarthy
• Organization: Madigan Army Medical Center

mary.s.mccarthy1.civ@health.mil

253-968-3695

Study Officials

• Mary S McCarthy, PhD

  Nurse Scientist, CNSCI

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: FED
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Senior Nurse Scientist

Model Details: 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.

Study Record Dates

• First Submitted: July 10, 2020
• First Posted: September 21, 2020
• Study Start: April 30, 2018
• Primary Completion: January 22, 2019
• Study Completion: April 1, 2019
• Last Updated: March 13, 2024
• Results First Posted: March 12, 2024

Record last verified: 2024-03

Locations

US (1)