The Effect of Oral Vitamin D Versus Narrow-Band UV-B Exposure on the Lipid Profile
NCT ID: NCT01688102
Last Updated: 2017-11-06
Study Results
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View full resultsBasic Information
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COMPLETED
NA
118 participants
INTERVENTIONAL
2012-09-30
2015-07-31
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Oral Vitamin D3
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
Ultraviolet Light
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
Interventions
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Oral Vitamin D3
50,000 units orally, each week x8 weeks; supplemental doses of 50,000 units orally, each month thereafter as needed
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
Eligibility Criteria
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Inclusion Criteria
2. Vitamin D 25-OH level \< 20 ng/ml
Exclusion Criteria
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
18 Years
70 Years
ALL
Yes
Sponsors
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Rockefeller University
OTHER
Responsible Party
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Manish Ponda
Assistant Professor of Clinical Investigation
Principal Investigators
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Manish Ponda, MD MS
Role: PRINCIPAL_INVESTIGATOR
The Rockefeller University
Locations
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The Rockefeller University
New York, New York, United States
Countries
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References
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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.
Other Identifiers
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MPO-0787
Identifier Type: -
Identifier Source: org_study_id