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

Vitamin D Deficiency Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01688102
• Other study ID #: MPO-0787
• Status: Completed
• Phase: N/A
• First received: September 12, 2012
• Last updated: October 6, 2017
• Start date: September 2012
• Est. completion date: July 2015

Study information

• Verified date: October 2017
• Source: Rockefeller University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 118
• Est. completion date: July 2015
• Est. primary completion date: July 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Vitamin D Deficiency

Intervention

Dietary Supplement:
• Oral Vitamin D3
50,000 units orally, each week x8 weeks; supplemental doses of 50,000 units orally, each month thereafter as needed

Radiation:
• 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

Locations

Country	Name	City	State
United States	The Rockefeller University	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
Rockefeller University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Correlation Between Change in LDL Cholesterol and Change in Calcium	The Correlation between change in LDL cholesterol and change in serum calcium	2 months
Other	Correlation Between Change in LDL Cholesterol and Change in PTH		2 months
Other	Gene Expression Changes in Peripheral Blood	Interferon response genesets (curated by GSEA). Values are presented as the normalized enrichment score, a metric of gene upregulation (when positive) or down-regulation (when negative), normalized for gene set size. This is a useful basis for comparison for direction and degree of change between treatment groups and GSEA genesets.	baseline vs. 2 months
Other	Gene Expression Changes in Skin	Interferon response genesets (curated by GSEA). Values are presented as the normalized enrichment score, a metric of gene upregulation (when positive) or down-regulation (when negative), normalized for gene set size. This is a useful basis for comparison for direction and degree of change between treatment groups and GSEA genesets.	baseline vs. 2 months
Primary	Change in LDL Cholesterol Level		baseline and 6 months or last observation carried forward (minimum 2 months)
Secondary	Change in Total Cholesterol	Change in Total Cholesterol	baseline and 6 months or last observation carried forward (minimum 2 months)
Secondary	Change in HDL Cholesterol		baseline and 6 months or last observation carried forward (minimum 2 months)
Secondary	Change in Triglycerides		baseline 6 months or last observation carried forward (minimum 2 months)
Secondary	Change in C Reactive Protein		baseline and 6 months
Secondary	Change in 25(OH)D		baseline vs. 6 months
Secondary	Change in Serum Calcium		baseline vs. 6 months
Secondary	Change in Parathyroid Hormone (PTH)		baseline vs.6 months