The Effect of Oral Vitamin D Versus Narrow-Band UV-B Exposure on the Lipid Profile

Rockefeller University

Status: Completed

Conditions: Vitamin D Deficiency

Treatments: Radiation: Ultraviolet Light; Dietary Supplement: Oral Vitamin D3

Study type: Interventional

Funder types: Other

Identifiers

NCT01688102

MPO-0787

Details and patient eligibility

About

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.

Full 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.

Enrollment: 118 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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118 participants in 2 patient groups

Oral Vitamin D3

Active Comparator group

Description:

Participants will receive oral vitamin D3 50,000 units weekly for 8 weeks. If 25(OH)D levels remain \<35 ng/ml, subjects will receive additional doses of oral vitamin D.

Treatment:

Dietary Supplement: Oral Vitamin D3

Ultraviolet Light

Active Comparator group

Description:

Subjects will receive 16 treatments with ultraviolet light (narrow band UVB) over 8 weeks. If 25(OH)D levels remain \<35 ng/ml, subjects will receive additional doses of narrow band UVB.

Treatment:

Radiation: Ultraviolet Light