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Completed

NCT Number: NCT01688102

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.

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Key information

Conditions

Vitamin D Deficiency Avitaminosis Deficiency Diseases Malnutrition Nutrition Disorders Nutritional and Metabolic Diseases

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

The Rockefeller University

New York, 10065, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

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

Primary outcomes

  1. Change in LDL Cholesterol Level

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

Secondary outcomes

  1. Change in Total Cholesterol

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

    Change in Total Cholesterol

  2. Change in HDL Cholesterol

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

  3. Change in Triglycerides

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

  4. Change in C Reactive Protein

    Time frame: baseline and 6 months

  5. Change in 25(OH)D

    Time frame: baseline vs. 6 months

  6. Change in Serum Calcium

    Time frame: baseline vs. 6 months

  7. Change in Parathyroid Hormone (PTH)

    Time frame: baseline vs.6 months

Other outcomes

  1. Correlation Between Change in LDL Cholesterol and Change in Calcium

    Time frame: 2 months

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

  2. Correlation Between Change in LDL Cholesterol and Change in PTH

    Time frame: 2 months

  3. Gene Expression Changes in Peripheral Blood

    Time frame: baseline vs. 2 months

    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.

  4. Gene Expression Changes in Skin

    Time frame: baseline vs. 2 months

    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.

Sponsors and collaborators

Lead sponsor

Rockefeller University

Other

Registry information

Important dates

Study start
2012
Primary completion
2015
Study completion
2015
First posted
Sep 19, 2012
Registry last updated
Nov 6, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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