N/A
Completed N=118
The Effect of Oral Vitamin D Versus Narrow-Band UV-B Exposure on the Lipid Profile
Source: ClinicalTrials.gov NCT01688102 ↗Enrolled (actual)
118
Serious AEs
2.5%
Results posted
Sep 2016
Primary outcomePrimary: Change in LDL Cholesterol Level — 3.2; 1.4 mg/dl
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in LDL Cholesterol Level |
3.2; 1.4 | — |
| SECONDARY Change in Total Cholesterol |
4.1; 2.0 | — |
| SECONDARY Change in HDL Cholesterol |
0.2; 0.3 | — |
| SECONDARY Change in Triglycerides |
2.6; 1.7 | — |
| SECONDARY Change in C Reactive Protein |
1.88; -.11 | — |
| SECONDARY Change in 25(OH)D |
18.7; 15.6 | — |
| SECONDARY Change in Serum Calcium |
.09; .07 | — |
| SECONDARY Change in Parathyroid Hormone (PTH) |
-5; -9 | — |
Eligibility Criteria
Inclusion Criteria
- Age > 18 years
- Vitamin D 25-OH level 10.5 mg/dl
- Serum phosphorus > 5.5 mg/dl
- Serum parathyroid hormone (PTH) level 190 mg/dl
- History of recent acute infection (within 1 month)
- Glomerular filtration rate(GFR) 3x ULN)
- Current use of Vitamin D > 400 IU/day
- Current use of any statins, fibrates, niacin, or ezetimibe
- Current use of any medications affecting sensitivity to UV light
- Pregnancy (self-reported)
- Intentional UV exposure (e.g. tanning bed use) in the last 2 weeks or planned use while participating in the study
- history of malignancy not in remission (> 6 months)
- History of malignant melanoma
- Participation in an investigational drug study within 30 days of the screening visit
- Any medical, psychological or social condition that, in the opinion of the Investigator, would jeopardize the health or well-being of the participant during any study procedures or the integrity of the data.
- History of any non-melanoma skin cancer
Data sourced from ClinicalTrials.gov (NCT01688102). 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.