Overview

This trial is active, not recruiting.

Condition vitamin d deficiency
Treatments oral vitamin d3, ultraviolet light
Sponsor Rockefeller University
Start date September 2012
End date July 2015
Trial size 120 participants
Trial identifier NCT01688102, MPO-0787

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose treatment
Arm
(Active Comparator)
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.
oral vitamin d3
50,000 units orally, each week x8 weeks; supplemental doses of 50,000 units orally, each month thereafter as needed
(Active Comparator)
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.
ultraviolet light
16 treatments, 2-3 times weekly over 8 weeks; initial dose 45-75 seconds, whole-body exposure except face and groin, increasing by 10% as tolerated, to a maximum of 4.5 minutes

Primary Outcomes

Measure
Change in LDL Cholesterol Level
time frame: baseline and 6 months or last observation carried forward (minimum 2 months)

Secondary Outcomes

Measure
Change in Total Cholesterol
time frame: baseline and 6 months or last observation carried forward (minimum 2 months)
Change in HDL Cholesterol
time frame: baseline and 6 months or last observation carried forward (minimum 2 months)
Change in triglycerides
time frame: baseline 6 months or last observation carried forward (minimum 2 months)
Change in hs-CRP
time frame: baseline and 6 months or last observation carried forward (minimum 2 months)
Change in 25(OH)D
time frame: baseline vs. 2 months vs. 6 months or last observation carried forward (minimum 2 months)
Change in serum calcium
time frame: baseline vs. 2 months vs. 6 months or last observation carried forward (minimum 2 months)
Change in PTH
time frame: baseline vs. 2 months vs. 6 months or last observation carried forward (minimum 2 months)

Eligibility Criteria

Male or female participants from 18 years up to 70 years old.

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 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 (AST or 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

Additional Information

Official title The Effect of Oral Vitamin D Versus Narrow-Band UV-B Exposure on the Lipid Profile
Principal investigator Manish Ponda, MD MS
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 partcipants from both groups will participate in a skin biopsy cohort, where skin biopsies are obtained before and after 8 weeks of treatment.
Trial information was received from ClinicalTrials.gov and was last updated in October 2015.
Information provided to ClinicalTrials.gov by Rockefeller University.