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

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.

Study Overview

• Status: Completed
• Conditions: Vitamin D Deficiency
• Intervention / Treatment: Dietary supplement: Oral Vitamin D3; Radiation: Ultraviolet Light

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.

• Study Type: Interventional
• Enrollment (Actual): 118
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • New York
    • New York, New York, United States, 10065
      • The Rockefeller University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: 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.	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
Active Comparator: 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.	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Change in LDL Cholesterol Level	baseline and 6 months or last observation carried forward (minimum 2 months)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Total Cholesterol	Change in Total Cholesterol	baseline and 6 months or last observation carried forward (minimum 2 months)
Change in HDL Cholesterol		baseline and 6 months or last observation carried forward (minimum 2 months)
Change in Triglycerides		baseline 6 months or last observation carried forward (minimum 2 months)
Change in C Reactive Protein		baseline and 6 months
Change in 25(OH)D		baseline vs. 6 months
Change in Serum Calcium		baseline vs. 6 months
Change in Parathyroid Hormone (PTH)		baseline vs.6 months

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Correlation Between Change in LDL Cholesterol and Change in Calcium	The Correlation between change in LDL cholesterol and change in serum calcium	2 months
Correlation Between Change in LDL Cholesterol and Change in PTH		2 months
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
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

Collaborators and Investigators

• Sponsor: Rockefeller University
• Investigators: Principal Investigator: Manish Ponda, MD MS, The Rockefeller University

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: September 1, 2012
• Primary Completion (Actual): July 1, 2015
• Study Completion (Actual): July 1, 2015

Study Registration Dates

• First Submitted: September 12, 2012
• First Submitted That Met QC Criteria: September 14, 2012
• First Posted (Estimate): September 19, 2012

Study Record Updates

• Last Update Posted (Actual): November 6, 2017
• Last Update Submitted That Met QC Criteria: October 6, 2017
• Last Verified: October 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nutrition Disorders; Avitaminosis; Deficiency Diseases; Malnutrition; Vitamin D Deficiency; Physiological Effects of Drugs; Micronutrients; Vitamins; Bone Density Conservation Agents; Calcium-Regulating Hormones and Agents; Vitamin D; Cholecalciferol
• Other Study ID Numbers: MPO-0787