Trial Outcomes & Findings for Treatment of Vitamin D Deficiency in Intestinal Rehabilitation Clinic Patients With a Portable Ultraviolet B Lamp (NCT NCT01930539)
NCT ID: NCT01930539
Last Updated: 2023-10-04
Results Overview
Our hypothesis is that Ultraviolet B light with a portable Ultraviolet device will increase Total 25 hydroxy vitamin D level in Intestinal Rehabilitation Clinic patients. We will measure serum level of 25 hydroxy vitamin D at baseline and 12 weeks to monitor the response of Ultraviolet B exposure administered by the portable Ultraviolet B lamp.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
11 participants
Primary outcome timeframe
12 weeks
Results posted on
2023-10-04
Participant Flow
Participant milestones
| Measure |
Ultraviolet B Lamp
Intervention arm: Patients in the Ultraviolet B lamp group will continue vitamin D2/D3 daily and will receive 3 treatment sessions of Ultraviolet B light once a week for 12 weeks. Patients will receive Ultraviolet B light from Ultraviolet B lamp at a distance of 14 inches for duration of 5 minutes each area while wearing an Ultraviolet eye shield. Areas of skin exposure will include 3 different areas amounting to 27% of body surface area. 9% body surface area will include front of abdomen, lower back, each arm, each leg is 18%, each thigh. Ultraviolet B light sessions will be supervised and conducted by study personnel or Center for Clinical and Translational Research staff. A food questionnaire will be reviewed at each visit to assess dietary intake of calcium. Skin exam will be conducted at the beginning and end of the session.
Ultraviolet B lamp: Ultraviolet-Fluorescent lamp (KBD, Inc, Crescent Springs, Kentucky, USA) was designed to use Ultraviolet B emitting fluorescent bulbs that have lower heat emission and allows a larger area of skin exposure. The Lamp is equipped with a timer for improved safety. This device is FDA (Food and Drug Administration) approved.
|
Control
Patients in control group will continue with their current dose of Vitamin D2/D3 for 12 weeks.Patients will remain on the same steady dose for the duration of the study.These patients will not receive Ultraviolet B light sessions.
|
|---|---|---|
|
Overall Study
STARTED
|
5
|
6
|
|
Overall Study
COMPLETED
|
3
|
4
|
|
Overall Study
NOT COMPLETED
|
2
|
2
|
Reasons for withdrawal
| Measure |
Ultraviolet B Lamp
Intervention arm: Patients in the Ultraviolet B lamp group will continue vitamin D2/D3 daily and will receive 3 treatment sessions of Ultraviolet B light once a week for 12 weeks. Patients will receive Ultraviolet B light from Ultraviolet B lamp at a distance of 14 inches for duration of 5 minutes each area while wearing an Ultraviolet eye shield. Areas of skin exposure will include 3 different areas amounting to 27% of body surface area. 9% body surface area will include front of abdomen, lower back, each arm, each leg is 18%, each thigh. Ultraviolet B light sessions will be supervised and conducted by study personnel or Center for Clinical and Translational Research staff. A food questionnaire will be reviewed at each visit to assess dietary intake of calcium. Skin exam will be conducted at the beginning and end of the session.
Ultraviolet B lamp: Ultraviolet-Fluorescent lamp (KBD, Inc, Crescent Springs, Kentucky, USA) was designed to use Ultraviolet B emitting fluorescent bulbs that have lower heat emission and allows a larger area of skin exposure. The Lamp is equipped with a timer for improved safety. This device is FDA (Food and Drug Administration) approved.
|
Control
Patients in control group will continue with their current dose of Vitamin D2/D3 for 12 weeks.Patients will remain on the same steady dose for the duration of the study.These patients will not receive Ultraviolet B light sessions.
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
2
|
2
|
Baseline Characteristics
Treatment of Vitamin D Deficiency in Intestinal Rehabilitation Clinic Patients With a Portable Ultraviolet B Lamp
Baseline characteristics by cohort
| Measure |
Ultraviolet B Lamp
n=3 Participants
Intervention arm: Patients in the Ultraviolet B lamp group will continue vitamin D2/D3 daily and will receive 3 treatment sessions of Ultraviolet B light once a week for 12 weeks. Patients will receive Ultraviolet B light from Ultraviolet B lamp at a distance of 14 inches for duration of 5 minutes each area while wearing an Ultraviolet eye shield. Areas of skin exposure will include 3 different areas amounting to 27% of body surface area. 9% body surface area will include front of abdomen, lower back, each arm, each leg is 18%, each thigh. Ultraviolet B light sessions will be supervised and conducted by study personnel or Center for Clinical and Translational Research staff. A food questionnaire will be reviewed at each visit to assess dietary intake of calcium. Skin exam will be conducted at the beginning and end of the session.
Ultraviolet B lamp: Ultraviolet-Fluorescent lamp (KBD, Inc, Crescent Springs, Kentucky, USA) was designed to use Ultraviolet B emitting fluorescent bulbs that have lower heat emission and allows a larger area of skin exposure. The Lamp is equipped with a timer for improved safety. This device is FDA (Food and Drug Administration) approved.
|
Control
n=4 Participants
Patients in control group will continue with their current dose of Vitamin D2/D3 for 12 weeks.Patients will remain on the same steady dose for the duration of the study.These patients will not receive Ultraviolet B light sessions.
|
Total
n=7 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
3 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Age, Continuous
|
37 years
n=5 Participants
|
50 years
n=7 Participants
|
47 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
3 participants
n=5 Participants
|
4 participants
n=7 Participants
|
7 participants
n=5 Participants
|
|
Baseline vitamin D level
|
19 ng/mL
STANDARD_DEVIATION 9 • n=5 Participants
|
17 ng/mL
STANDARD_DEVIATION 7 • n=7 Participants
|
18 ng/mL
STANDARD_DEVIATION 8 • n=5 Participants
|
PRIMARY outcome
Timeframe: 12 weeksPopulation: Male and female adults age 19 to 72
Our hypothesis is that Ultraviolet B light with a portable Ultraviolet device will increase Total 25 hydroxy vitamin D level in Intestinal Rehabilitation Clinic patients. We will measure serum level of 25 hydroxy vitamin D at baseline and 12 weeks to monitor the response of Ultraviolet B exposure administered by the portable Ultraviolet B lamp.
Outcome measures
| Measure |
Ultraviolet B Lamp
n=3 Participants
Intervention arm: Patients in the Ultraviolet B lamp group will continue vitamin D2/D3 daily and will receive 3 treatment sessions of Ultraviolet B light once a week for 12 weeks. Patients will receive Ultraviolet B light from Ultraviolet B lamp at a distance of 14 inches for duration of 5 minutes each area while wearing an Ultraviolet eye shield. Areas of skin exposure will include 3 different areas amounting to 27% of body surface area. 9% body surface area will include front of abdomen, lower back, each arm, each leg is 18%, each thigh. Ultraviolet B light sessions will be supervised and conducted by study personnel or Center for Clinical and Translational Research staff. A food questionnaire will be reviewed at each visit to assess dietary intake of calcium. Skin exam will be conducted at the beginning and end of the session.
Ultraviolet B lamp: Ultraviolet-Fluorescent lamp (KBD, Inc, Crescent Springs, Kentucky, USA) was designed to use Ultraviolet B emitting fluorescent bulbs that have lower heat emission and allows a larger area of skin exposure. The Lamp is equipped with a timer for improved safety. This device is FDA (Food and Drug Administration) approved.
|
Control
n=4 Participants
Patients in control group will continue with their current dose of Vitamin D2/D3 for 12 weeks.Patients will remain on the same steady dose for the duration of the study.These patients will not receive Ultraviolet B light sessions.
|
|---|---|---|
|
25 Hydroxy Vitamin D Levels
Week 12
|
26 ng/mL
Standard Error 14
|
14 ng/mL
Standard Error 3
|
|
25 Hydroxy Vitamin D Levels
Week 0
|
19 ng/mL
Standard Error 9
|
17 ng/mL
Standard Error 7
|
SECONDARY outcome
Timeframe: 12 weeksHypovitaminosis D is associated with increased Parathyroid hormone secretion (inversely related to 25 hydroxy D), increased bone turnover, osteoporosis, histological osteomalacia and increased risk of hip and other fractures, and, in its most severe expression,clinical osteomalacia.
Outcome measures
| Measure |
Ultraviolet B Lamp
n=3 Participants
Intervention arm: Patients in the Ultraviolet B lamp group will continue vitamin D2/D3 daily and will receive 3 treatment sessions of Ultraviolet B light once a week for 12 weeks. Patients will receive Ultraviolet B light from Ultraviolet B lamp at a distance of 14 inches for duration of 5 minutes each area while wearing an Ultraviolet eye shield. Areas of skin exposure will include 3 different areas amounting to 27% of body surface area. 9% body surface area will include front of abdomen, lower back, each arm, each leg is 18%, each thigh. Ultraviolet B light sessions will be supervised and conducted by study personnel or Center for Clinical and Translational Research staff. A food questionnaire will be reviewed at each visit to assess dietary intake of calcium. Skin exam will be conducted at the beginning and end of the session.
Ultraviolet B lamp: Ultraviolet-Fluorescent lamp (KBD, Inc, Crescent Springs, Kentucky, USA) was designed to use Ultraviolet B emitting fluorescent bulbs that have lower heat emission and allows a larger area of skin exposure. The Lamp is equipped with a timer for improved safety. This device is FDA (Food and Drug Administration) approved.
|
Control
n=4 Participants
Patients in control group will continue with their current dose of Vitamin D2/D3 for 12 weeks.Patients will remain on the same steady dose for the duration of the study.These patients will not receive Ultraviolet B light sessions.
|
|---|---|---|
|
Serum Intact Parathyroid Hormone Level
Week 12
|
62 pg/ml
Standard Error 59
|
70 pg/ml
Standard Error 23
|
|
Serum Intact Parathyroid Hormone Level
Week 0
|
139 pg/ml
Standard Error 38
|
82 pg/ml
Standard Error 30
|
Adverse Events
Ultraviolet B Lamp
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Control
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place