N/A
Completed N=106
Comparing a Novel Phototherapy Kiosk to Oral Vitamin D Supplementation
Hypovitaminosis D
Source: ClinicalTrials.gov NCT04556136 ↗
Enrolled (actual)
106
Serious AEs
0.0%
Results posted
Mar 2024
Primary outcomePrimary: Serum Vitamin D Level — 30.0; 25.5 ng/mL — p=0.01
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Serum Vitamin D Level |
30.0; 25.5 | 0.01 sig |
| PRIMARY Change in Serum Vitamin D Level From Baseline to Week 14 |
27; 21 | — |
| PRIMARY Percentage of Participants With Adherence |
98; 98 | — |
| SECONDARY Device Acceptability Using Device Usability Scale |
55.38 | — |
| SECONDARY Number of Subjects Retained at 14 Weeks |
39; 41 | — |
Eligibility 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
Data sourced from ClinicalTrials.gov (NCT04556136). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.