Trial Outcomes & Findings for Ultraviolet Light And Vitamin D In Subjects With Fat Malabsorption Or After Gastric Bypass Surgery (NCT NCT01910792)
NCT ID: NCT01910792
Last Updated: 2017-07-11
Results Overview
Increase circulating 25(OH)D levels
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
19 participants
Primary outcome timeframe
Baseline, Months 1, 2, 3
Results posted on
2017-07-11
Participant Flow
Patients will be recruited from the Center for Digestive Disorders or the Endocrinology, Diabetes, and Nutrition clinic during regularly scheduled outpatient visits. Subjects will also be recruited by placing IRB approved posters around BUMC and also placing an IRB approved email in the monthly resear
Participant milestones
| Measure |
Pts w/ Fat Malabsorption
Patients with fat malabsorption syndromes will be exposed to a Sperti Lamp 3x/week
Sperti Lamp: UV light exposure 3 times per week for 12 weeks
|
Pts w/ Gastric Bypass
Patients who have had gastric bypass surgery will be exposed to a Sperti Lamp 3x/week
Sperti Lamp: UV light exposure 3 times per week for 12 weeks
|
|---|---|---|
|
Overall Study
STARTED
|
10
|
9
|
|
Overall Study
COMPLETED
|
10
|
9
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Group 2
n=9 Participants
Patients who have had gastric bypass surgery will be exposed to a Sperti Lamp 3x/week
Sperti Lamp: UV light exposure 3 times per week for 12 weeks
|
Group 1
n=10 Participants
Patients with fat malabsorption syndromes will be exposed to a Sperti Lamp 3x/week
Sperti Lamp: UV light exposure 3 times per week for 12 weeks
|
Total
n=19 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=9 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=19 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
9 Participants
n=9 Participants
|
10 Participants
n=10 Participants
|
19 Participants
n=19 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=9 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=19 Participants
|
|
Sex: Female, Male
Female
|
4 Participants
n=9 Participants
|
6 Participants
n=10 Participants
|
10 Participants
n=19 Participants
|
|
Sex: Female, Male
Male
|
5 Participants
n=9 Participants
|
4 Participants
n=10 Participants
|
9 Participants
n=19 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Region of Enrollment
United States
|
9 participants
n=9 Participants
|
10 participants
n=10 Participants
|
19 participants
n=19 Participants
|
|
Established diagnosis of Fat Malabsorption Syndromes
|
0 Participants
n=9 Participants
|
10 Participants
n=10 Participants
|
10 Participants
n=19 Participants
|
|
History of Gastric Bypass at least 3 months post-op with no continuing complications
|
9 Participants
n=9 Participants
|
0 Participants
n=10 Participants
|
9 Participants
n=19 Participants
|
PRIMARY outcome
Timeframe: Baseline, Months 1, 2, 3Population: Only 3 subjects in each Arm had a conclusive set of data eligible for analysis.
Increase circulating 25(OH)D levels
Outcome measures
| Measure |
Pts w/ Gastric Bypass
n=3 Participants
Patients who have had gastric bypass surgery will be exposed to a Sperti Lamp 3x/week
Sperti Lamp: UV light exposure 3 times per week for 12 weeks
|
Pts w/ Fat Malabsorption
n=3 Participants
Patients with fat malabsorption syndromes will be exposed to a Sperti Lamp 3x/week
Sperti Lamp: UV light exposure 3 times per week for 12 weeks
|
|---|---|---|
|
# of Pts w/ Enhanced Vitamin D Status
|
3 Participants
|
3 Participants
|
Adverse Events
Pts w/ Gastric Bypass
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Pts w/ Fat Malabsorption
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
Dr. Michael F Holick
Vitamin D, Skin, and Bone Research Laboratory
Phone: 6176384546
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place