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

Primary Purpose

Vitamin D Deficiency

Status

Completed

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Oral Vitamin D3

Ultraviolet Light

About this trial

This is an interventional treatment trial for Vitamin D Deficiency

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

Age > 18 years
Vitamin D 25-OH level < 20 ng/ml

Exclusion Criteria:

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

Sites / Locations

The Rockefeller University

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Arm Label

Oral Vitamin D3

Ultraviolet Light

Arm 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.

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.

Outcomes

Primary Outcome Measures

Change in LDL Cholesterol Level

Secondary Outcome Measures

Change in Total Cholesterol

Change in HDL Cholesterol

Change in Triglycerides

Change in C Reactive Protein

Change in 25(OH)D

Change in Serum Calcium

Change in Parathyroid Hormone (PTH)

Full Information

NCT ID

NCT01688102

First Posted

September 12, 2012

Last Updated

October 6, 2017

Sponsor

Rockefeller University

1. Study Identification

Unique Protocol Identification Number

NCT01688102

Brief Title

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

2. Study Status

Record Verification Date

October 2017

Overall Recruitment Status

Completed

Study Start Date

September 2012 (undefined)

Primary Completion Date

July 2015 (Actual)

Study Completion Date

July 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Rockefeller University

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Vitamin D Deficiency

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

118 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Oral Vitamin D3

Arm Type

Active Comparator

Arm 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.

Arm Title

Ultraviolet Light

Arm Type

Active Comparator

Arm 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.

Intervention Type

Dietary Supplement

Intervention Name(s)

Oral Vitamin D3

Intervention Description

50,000 units orally, each week x8 weeks; supplemental doses of 50,000 units orally, each month thereafter as needed

Intervention Type

Radiation

Intervention Name(s)

Ultraviolet Light

Intervention Description

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 Outcome Measure Information:

Title

Change in LDL Cholesterol Level

Time Frame

baseline and 6 months or last observation carried forward (minimum 2 months)

Secondary Outcome Measure Information:

Title

Change in Total Cholesterol

Description

Change in Total Cholesterol

Time Frame

baseline and 6 months or last observation carried forward (minimum 2 months)

Title

Change in HDL Cholesterol

Time Frame

baseline and 6 months or last observation carried forward (minimum 2 months)

Title

Change in Triglycerides

Time Frame

baseline 6 months or last observation carried forward (minimum 2 months)

Title

Change in C Reactive Protein

Time Frame

baseline and 6 months

Title

Change in 25(OH)D

Time Frame

baseline vs. 6 months

Title

Change in Serum Calcium

Time Frame

baseline vs. 6 months

Title

Change in Parathyroid Hormone (PTH)

Time Frame

baseline vs.6 months

Other Pre-specified Outcome Measures:

Title

Correlation Between Change in LDL Cholesterol and Change in Calcium

Description

The Correlation between change in LDL cholesterol and change in serum calcium

Time Frame

2 months

Title

Correlation Between Change in LDL Cholesterol and Change in PTH

Time Frame

2 months

Title

Gene Expression Changes in Peripheral Blood

Description

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.

Time Frame

baseline vs. 2 months

Title

Gene Expression Changes in Skin

Description

Time Frame

baseline vs. 2 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

70 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Age > 18 years Vitamin D 25-OH level < 20 ng/ml Exclusion Criteria: Serum calcium > 10.5 mg/dl Serum phosphorus > 5.5 mg/dl Serum parathyroid hormone (PTH) level < 12 pg/ml LDL cholesterol > 190 mg/dl History of recent acute infection (within 1 month) Glomerular filtration rate(GFR) < 60 mL/min Liver Function tests indicative of liver disease (aspartate aminotransferase (AST) or alanine transferase (ALT) > 3x ULN) Current use of Vitamin D > 400 IU/day Current use of any statins, fibrates, niacin, or ezetimibe Current use of any medications affecting sensitivity to UV light Pregnancy (self-reported) Intentional UV exposure (e.g. tanning bed use) in the last 2 weeks or planned use while participating in the study history of malignancy not in remission (> 6 months) History of malignant melanoma Participation in an investigational drug study within 30 days of the screening visit 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. History of any non-melanoma skin cancer

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Manish Ponda, MD MS

Organizational Affiliation

The Rockefeller University

Official's Role

Principal Investigator

Facility Information:

Facility Name

The Rockefeller University

City

New York

State/Province

New York

ZIP/Postal Code

10065

Country

United States

12. IPD Sharing Statement

Citations:

PubMed Identifier

28228421

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.

Results Reference

derived

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

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