Clinical trial NCT01688102: The Effect of Oral Vitamin D Versus Narrow-Band UV-B Exposure on the Lipid Profile
Official title: The Effect of Oral Vitamin D Versus Narrow-Band UV-B Exposure on the Lipid Profile
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Vitamin D Deficiency
Lead sponsor: Rockefeller University
Sponsor class: OTHER
First posted: 2012-09-19
Enrollment: 118
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: Inclusion Criteria:

1. Age \> 18 years
2. Vitamin D 25-OH level \< 20 ng/ml

Exclusion Criteria:

1. Serum calcium \> 10.5 mg/dl
2. Serum phosphorus \> 5.5 mg/dl
3. Serum parathyroid hormone (PTH) level \< 12 pg/ml
4. LDL cholesterol \> 190 mg/dl
5. History of recent acute infection (within 1 month)
6. Glomerular filtration rate(GFR) \< 60 mL/min
7. Liver Function tests indicative of liver disease (aspartate aminotransferase (AST) or alanine transferase (ALT) \> 3x ULN)
8. Current use of Vitamin D \> 400 IU/day
9. Current use of any statins, fibrates, niacin, or ezetimibe
10. Current use of any medications affecting sensitivity to UV light
11. Pregnancy (self-reported)
12. Intentional UV exposure (e.g. tanning bed use) in the last 2 weeks or planned use while participating in the study
13. history of malignancy not in remission (\> 6 months)
14. History of malignant melanoma
15. Participation in an investigational drug study within 30 days of the screening visit
16. 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.
17. History of any non-melanoma skin cancer

Primary outcomes:
measure: Change in LDL Cholesterol Level
timeFrame: baseline and 6 months or last observation carried forward (minimum 2 months)
Secondary outcomes:
measure: Change in Total Cholesterol
timeFrame: baseline and 6 months or last observation carried forward (minimum 2 months)
measure: Change in HDL Cholesterol
timeFrame: baseline and 6 months or last observation carried forward (minimum 2 months)
measure: Change in Triglycerides
timeFrame: baseline 6 months or last observation carried forward (minimum 2 months)
measure: Change in C Reactive Protein
timeFrame: baseline and 6 months
measure: Change in 25(OH)D
timeFrame: baseline vs. 6 months
measure: Change in Serum Calcium
timeFrame: baseline vs. 6 months
measure: Change in Parathyroid Hormone (PTH)
timeFrame: baseline vs.6 months
Other outcomes:
measure: Correlation Between Change in LDL Cholesterol and Change in Calcium
timeFrame: 2 months
measure: Correlation Between Change in LDL Cholesterol and Change in PTH
timeFrame: 2 months
measure: Gene Expression Changes in Peripheral Blood
timeFrame: baseline vs. 2 months
measure: Gene Expression Changes in Skin
timeFrame: baseline vs. 2 months
Locations:
city: New York
country: United States
facility: The Rockefeller University
state: New York
Study officials:
affiliation: The Rockefeller University
name: Manish Ponda, MD MS
role: PRINCIPAL_INVESTIGATOR
References:
citation: Ponda MP, Liang Y, Kim J, Hutt R, Dowd K, Gilleaudeau P, Sullivan-Whalen MM, Rodrick T, Kim DJ, Barash I, Lowes MA, Breslow JL. A randomized clinical trial in vitamin D-deficient adults comparing replenishment with oral vitamin D3 with narrow-band UV type B light: effects on cholesterol and the transcriptional profiles of skin and blood. Am J Clin Nutr. 2017 May;105(5):1230-1238. doi: 10.3945/ajcn.116.150367. Epub 2017 Feb 22.