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Comparing a Novel Phototherapy Kiosk to Oral Vitamin D Supplementation

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ClinicalTrials.gov Identifier: NCT04556136
Recruitment Status : Completed
First Posted : September 21, 2020
Last Update Posted : September 21, 2020
Sponsor:
Information provided by (Responsible Party):
Mary McCarthy, 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.

Condition or disease Intervention/treatment Phase
Hypovitaminosis D Device: Standing Phototherapy Kiosk Dietary Supplement: D3 Oral supplement Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 98 participants
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)
Masking Description: 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.
Primary Purpose: Treatment
Official Title: A Pilot Feasibility Study Comparing a Novel Phototherapy Kiosk to Supplementation to Promote Vitamin D Sufficiency
Actual Study Start Date : April 30, 2018
Actual Primary Completion Date : January 22, 2019
Actual Study Completion Date : April 1, 2019

Resource links provided by the National Library of Medicine

Drug Information available for: Vitamin D

Arm Intervention/treatment
Experimental: Standing Phototherapy Kiosk (SPK)
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
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.
Other Name: Phototherapy Booth

Active Comparator: 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.
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.
Other Name: Vitamin D




Primary Outcome Measures :
  1. Serum vitamin D level [ Time Frame: Baseline ]
    25 Hydroxyvitamin D level in the blood

  2. Change from baseline serum vitamin D level [ Time Frame: 10 weeks ]
    25 Hydroxyvitamin D level in the blood

  3. Change from baseline serum vitamin D level [ Time Frame: 14 weeks ]
    25 Hydroxyvitamin D level in the blood


Secondary Outcome Measures :
  1. Device acceptability using Device Usability Scale [ Time Frame: 14 weeks ]
    User satisfaction with the novel device

  2. Device feasibility [ Time Frame: 14 weeks ]
    Retention



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Ages Eligible for Study:   18 Years to 69 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04556136


Locations
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United States, Washington
Madigan Army Medical Center
Tacoma, Washington, United States, 98431
Sponsors and Collaborators
Madigan Army Medical Center
Investigators
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Principal Investigator: Mary S McCarthy, PhD Nurse Scientist, CNSCI
Publications:
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Responsible Party: Mary McCarthy, Senior Nurse Scientist, Madigan Army Medical Center
ClinicalTrials.gov Identifier: NCT04556136    
Other Study ID Numbers: 217121
First Posted: September 21, 2020    Key Record Dates
Last Update Posted: September 21, 2020
Last Verified: September 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: Yes
Product Manufactured in and Exported from the U.S.: No
Keywords provided by Mary McCarthy, Madigan Army Medical Center:
VitaminD
UVBPhototherapy
Military
Additional relevant MeSH terms:
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Rickets
Avitaminosis
Vitamin D Deficiency
Deficiency Diseases
Malnutrition
Nutrition Disorders
Bone Diseases, Metabolic
Bone Diseases
Musculoskeletal Diseases
Metabolic Diseases
Calcium Metabolism Disorders
Vitamin D
Vitamins
Micronutrients
Nutrients
Growth Substances
Physiological Effects of Drugs
Bone Density Conservation Agents