Vitamin D Deficiency, Vitamin D Insufficiency
Conditions
Keywords
Vitamin D, Ultraviolet B radiation, SOLIUS System
Brief summary
The aim of this study is to evaluate the safety and effectiveness of the SOLIUS System in improving serum levels of 25-hydroxyvitamin D in vitamin D deficient/ insufficient adults of various skin types. The investigators will conduct a double-blinded randomized clinical trial in 100 adults to compare the changes in serum 25-hydroxyvitamin D levels between subjects who received and do not receive weekly exposures to Ultraviolet B Radiation (UVB) generated by the SOLIUS System for 16 weeks.
Detailed description
Study enrollment Approximately 100 healthy adults will be enrolled ages 22 or older; both sexes, for vitamin D deficiency screening in order to enroll 80 adults with vitamin D deficiency/insufficiency (serum 25-hydroxyvitamin D \<30 ng/mL). Participants will be randomized 1:1 into two groups: 40 adults for treatment arm who will receive weekly exposures of ultraviolet radiation generated by the SOLIUS System, and 40 adults for sham comparator arm. Study procedure The treatment group that will be exposed to the SOLIUS System will first undergo an evaluation of each individual's sensitivity to the SOLIUS System UVB using the device titration system for the first 5 weeks. Once the UVB dose is determined during the 5 weeks, the subjects will be enrolled in a 16-week study where they will be exposed to their individualized dose. For the sham comparator group, they will undergo the procedures as the treated group with the exception that the SOLIUS System will only be turned on to emit visible radiation. At these visits, each subject assigned into both groups will be asked questions about consumption of vitamin D, sun exposure, and whether he/she has had any adverse changes in his/her health. Serum 25-hydroxyvitamin D levels will be measured at baseline and monthly, and the levels will be analyzed to compare between those who receive and who do not receive the UVB radiation intervention for baseline and during the 16-week treatment period. After the 16-week intervention, participants will be asked to return to the study site weekly for measurement of serum 25-hydroxyvitamin D for 4 weeks. Serum 25(OH)D levels will be determined using the Liquid Chromatography with tandem mass spectrometry (LC/MS/MS) method. Safety will be monitored by interviewing the participants after each UVB exposure for any adverse events, including erythema or any other skin reactions.
Interventions
DEVICEUVB treatment
5 weeks of UVB titration to determine individual's UVB sensitivity followed by 16 weeks of UVB exposure intervention
DEVICESham comparator
5+16 weeks of visible light exposure
Sponsors
Boston University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
22 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
1. Age at least 22 years old 2. Male or Female 3. Skin Type I-VI 4. Women of child bearing potential must be on birth control and not pregnant based on a negative pregnancy test at baseline. 5. Ability and Willingness to give informed consent and comply to protocol requirements 6. Serum total 25(OH)D \< 30 ng/mL at the screening
Exclusion criteria
1. Ongoing treatment with supplemental or pharmacological doses of vitamin D, vitamin D metabolites or analogues 2. Pregnant 3. History of underlying photosensitivity 4. Use of medications that cause a photosensitivity reaction (including but not limited to): tetracycline, tretinoin, amiodarone, doxycycline, naproxen, diphenhydramine, methotrexate, and hydrochlorothiazide 5. History of skin cancer 6. Plan to received significant sun exposure below the 33rd parallel during study 7. Used tanning or phototherapy devices within the last 30 days 8. Vitamin D supplement use of more than 600 IUs daily 9. Systemic steroids use 10. H1 antihistamine use in the last 7 days 11. Diagnosed with light allergies (including but not limited to): actinic prurigo, polymorphous light eruption, or solar urticaria 12. Diagnosed with light sensitivities (including but not limited to): protoporphyria, photodermatitis, xeroderma pigmentosum, lupus erythematosus, chronic actinic dermatitis, or UV-sensitive syndrome
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Serum 25-Hydroxyvitamin D [25(OH)D] | Week 1, Week 21 | This outcome measures the change in serum 25-hydroxyvitamin D \[25(OH)D\] concentrations in participants from Week 1 to the end of the intervention period Week 21. |
| Distribution of Participants by Vitamin D Deficiency Categories at Week 1 | Week 1 | The three vitamin D categories are defined as: Deficient - \<20 ng/mL 25(OH)D, Insufficient - 21-29 ng/mL 25(OH)D, Sufficient - 30-100 ng/mL 25(OH)D. |
| Distribution of Participants by Vitamin D Deficiency Categories at Week 21 | Week 21 | The three vitamin D categories are defined as: Deficient - \<20 ng/mL 25(OH)D, Insufficient - 21-29 ng/mL 25(OH)D, Sufficient - 30-100 ng/mL 25(OH)D. |
Countries
United States
Participant flow
Recruitment details
Screened adults with vitamin D deficiency or insufficiency were selected for the study and randomized into the two study arms.
Participants by arm
| Arm | Count |
|---|---|
| UVB Treatment Arm Participants receive ultraviolet B radiation (UVB) exposure from the SOLIUS System. | 35 |
| Sham Comparator Arm Participants receive blue/violet light exposure from the SOLIUS System. | 34 |
| Total | 69 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Follow up Week 22-25 | Lost to Follow-up | 2 | 2 |
| Titration Week 1-5 | Lost to Follow-up | 2 | 8 |
| Treatment Week 6-21 | Lost to Follow-up | 4 | 4 |
Baseline characteristics
| Characteristic | Total | UVB Treatment Arm | Sham Comparator Arm |
|---|---|---|---|
| Age, Continuous | 34.26 years STANDARD_DEVIATION 11.01 | 34.09 years STANDARD_DEVIATION 10.78 | 34.44 years STANDARD_DEVIATION 11.4 |
| Fitzpatrick Skin Type Skin Type II/III | 60 Participants | 30 Participants | 30 Participants |
| Fitzpatrick Skin Type Skin Type IV/V | 9 Participants | 5 Participants | 4 Participants |
| Race and Ethnicity Not Collected | 0 Participants | — | — |
| Race/Ethnicity, Customized Asian | 11 Participants | 8 Participants | 3 Participants |
| Race/Ethnicity, Customized Black | 19 Participants | 6 Participants | 13 Participants |
| Race/Ethnicity, Customized Black- Cape Verde | 1 Participants | 1 Participants | 0 Participants |
| Race/Ethnicity, Customized Black- Hispanic | 1 Participants | 1 Participants | 0 Participants |
| Race/Ethnicity, Customized Black- Multirace | 1 Participants | 0 Participants | 1 Participants |
| Race/Ethnicity, Customized Hispanic | 8 Participants | 4 Participants | 4 Participants |
| Race/Ethnicity, Customized Hispanic- Multirace | 1 Participants | 1 Participants | 0 Participants |
| Race/Ethnicity, Customized Hispanic- White | 1 Participants | 1 Participants | 0 Participants |
| Race/Ethnicity, Customized Multirace | 1 Participants | 0 Participants | 1 Participants |
| Race/Ethnicity, Customized White | 25 Participants | 13 Participants | 12 Participants |
| Region of Enrollment United States | 69 participants | 35 participants | 34 participants |
| Screening 25(OH)D Levels | 20.41 ng/mL STANDARD_DEVIATION 5.21 | 20.57 ng/mL STANDARD_DEVIATION 5.3 | 19.71 ng/mL STANDARD_DEVIATION 5.16 |
| Sex: Female, Male Female | 44 Participants | 23 Participants | 21 Participants |
| Sex: Female, Male Male | 25 Participants | 12 Participants | 13 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 35 | 0 / 34 |
| other Total, other adverse events | 23 / 35 | 13 / 34 |
| serious Total, serious adverse events | 0 / 35 | 0 / 34 |
Outcome results
Primary
Change in Serum 25-Hydroxyvitamin D [25(OH)D]
This outcome measures the change in serum 25-hydroxyvitamin D \[25(OH)D\] concentrations in participants from Week 1 to the end of the intervention period Week 21.
Time frame: Week 1, Week 21
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| UVB Treatment Arm | Change in Serum 25-Hydroxyvitamin D [25(OH)D] | 10.14 ng/mL | Standard Deviation 7.5 |
| Sham Comparator Arm | Change in Serum 25-Hydroxyvitamin D [25(OH)D] | -2.3 ng/mL | Standard Deviation 4.9 |
Primary
Distribution of Participants by Vitamin D Deficiency Categories at Week 1
The three vitamin D categories are defined as: Deficient - \<20 ng/mL 25(OH)D, Insufficient - 21-29 ng/mL 25(OH)D, Sufficient - 30-100 ng/mL 25(OH)D.
Time frame: Week 1
Population: Only participants who completed the treatment are analyzed (27 in the treatment and 20 in the control arm).
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| UVB Treatment Arm | Distribution of Participants by Vitamin D Deficiency Categories at Week 1 | Deficient | 19 Participants |
| UVB Treatment Arm | Distribution of Participants by Vitamin D Deficiency Categories at Week 1 | Insufficient | 6 Participants |
| UVB Treatment Arm | Distribution of Participants by Vitamin D Deficiency Categories at Week 1 | Sufficient | 2 Participants |
| Sham Comparator Arm | Distribution of Participants by Vitamin D Deficiency Categories at Week 1 | Deficient | 9 Participants |
| Sham Comparator Arm | Distribution of Participants by Vitamin D Deficiency Categories at Week 1 | Insufficient | 10 Participants |
| Sham Comparator Arm | Distribution of Participants by Vitamin D Deficiency Categories at Week 1 | Sufficient | 1 Participants |
Primary
Distribution of Participants by Vitamin D Deficiency Categories at Week 21
The three vitamin D categories are defined as: Deficient - \<20 ng/mL 25(OH)D, Insufficient - 21-29 ng/mL 25(OH)D, Sufficient - 30-100 ng/mL 25(OH)D.
Time frame: Week 21
Population: Only participants who completed the treatment are analyzed (27 in the treatment and 20 in the control arm).
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| UVB Treatment Arm | Distribution of Participants by Vitamin D Deficiency Categories at Week 21 | Sufficient | 11 Participants |
| UVB Treatment Arm | Distribution of Participants by Vitamin D Deficiency Categories at Week 21 | Deficient | 3 Participants |
| UVB Treatment Arm | Distribution of Participants by Vitamin D Deficiency Categories at Week 21 | Insufficient | 13 Participants |
| Sham Comparator Arm | Distribution of Participants by Vitamin D Deficiency Categories at Week 21 | Deficient | 16 Participants |
| Sham Comparator Arm | Distribution of Participants by Vitamin D Deficiency Categories at Week 21 | Insufficient | 4 Participants |
| Sham Comparator Arm | Distribution of Participants by Vitamin D Deficiency Categories at Week 21 | Sufficient | 0 Participants |