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

NCT01688102 | Completed Results

• 1 other identifier: MPO-0787
• Study Type: interventional
• Target: 118
• Locations: 1 country
• Sites: 1

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.

Conditions

Vitamin D Deficiency

Outcome Measures

Primary Outcomes (1)

• Change in LDL Cholesterol Level

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

Secondary Outcomes (7)

• 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

Other Outcomes (4)

• Correlation Between Change in LDL Cholesterol and Change in Calcium

  2 months

• Correlation Between Change in LDL Cholesterol and Change in PTH

  2 months

• Gene Expression Changes in Peripheral Blood

  baseline vs. 2 months

Study Arms (2)

Oral Vitamin D3

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.

Dietary Supplement: Oral Vitamin D3

Ultraviolet Light

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.

Radiation: Ultraviolet Light

Interventions

Oral Vitamin D3 DIETARY_SUPPLEMENT

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

Oral Vitamin D3

Ultraviolet Light RADIATION

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

Ultraviolet Light

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Rockefeller University: lead

Study Sites (1)

The Rockefeller University

New York, New York, 10065, United States

Location

Related Publications (1)

• 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.

  PMID: 28228421 DERIVED

MeSH Terms

Conditions

Vitamin D Deficiency

Interventions

Cholecalciferol; Ultraviolet Rays

Condition Hierarchy (Ancestors)

Avitaminosis; Deficiency Diseases; Malnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Cholestenes; Cholestanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Sterols; Vitamin D; Secosteroids; Membrane Lipids; Lipids; Light; Electromagnetic Radiation; Electromagnetic Phenomena; Magnetic Phenomena; Physical Phenomena; Optical Phenomena; Radiation; Radiation, Ionizing; Radiation, Nonionizing; Sunlight; Weather; Atmosphere; Environment; Ecological and Environmental Phenomena; Biological Phenomena; Meteorological Concepts; Environment and Public Health

Results Point of Contact

• Title: Dr. Manish Ponda
• Organization: The Rockefeller University

mponda@rockefeller.edu

212-327-7631

Study Officials

• Manish Ponda, MD MS

  The Rockefeller University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Clinical Investigation

Study Record Dates

• First Submitted: September 12, 2012
• First Posted: September 19, 2012
• Study Start: September 1, 2012
• Primary Completion: July 1, 2015
• Study Completion: July 1, 2015
• Last Updated: November 6, 2017
• Results First Posted: September 23, 2016

Record last verified: 2017-10

Locations

US (1)