Ignite Creation Date:
2025-12-25 @ 3:47 AM
Ignite Modification Date:
2026-02-08 @ 6:48 PM
Study NCT ID:
NCT01688102
Status:
COMPLETED
Last Update Posted:
2017-11-06
First Post:
2012-09-12
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
The Effect of Oral Vitamin D Versus Narrow-Band UV-B Exposure on the Lipid Profile
Sponsor:
Rockefeller University
Organization:
Study Overview
Official Title:
The Effect of Oral Vitamin D Versus Narrow-Band UV-B Exposure on the Lipid Profile
Status:
COMPLETED
Status Verified Date:
2017-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Participants in this study will be randomized to receive either oral vitamin D pills OR ultraviolet light treatment. The investigators will compare how these two methods of raising vitamin D levels will affect cholesterol levels.
Detailed Description:
Potential subjects will be screened for eligibility, including serum 25(OH)D levels \<20ng/ml. Eligible subjects will be randomly assigned to receive either: 1) oral vitamin D3, 50,000 units weekly for 8 weeks or 2) narrow-band UVB radiation, 2 treatments/wk for 8 weeks. Duration of treatment will be based on skin type. After 8 weeks, 25(OH)D levels will be measured monthly. For participants with levels \<35 ng/ml, additional doses of oral vitamin D3 or UV radiation will be administered.
A subset of participants from both groups will participate in a skin biopsy cohort, where skin biopsies are obtained before and after 8 weeks of treatment.
A subset of participants from both groups will participate in a skin biopsy cohort, where skin biopsies are obtained before and after 8 weeks of treatment.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: