The Effect of a High-dose Oral Vitamin D3 Bolus on Serum 25(OH)D3 and Vitamin D Receptor Target Gene Expression (VitDbol)

July 28, 2016 updated by: University of Eastern Finland

The Effect of a High-dose Oral Vitamin D3 Bolus on Serum 25-hydroxyvitamin D3 and Vitamin D Receptor Target Gene Expression (VitDbol)

The purpose of the study is to investigate whether a high-dose vitamin D3 oral bolus (2000 micrograms) produces marked vitamin D receptor target gene expression response and whether there is large inter-individual variation.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Serum 25-hydroxyvitamin D [25(OH)D3] is a well-established marker for vitamin D status of the human body. In addition to the general importance of vitamin D for bone health, low serum 25(OH)D3 concentrations have been associated with increased risk of several health outcomes, such as autoimmune diseases, type 2 diabetes and cardiovascular complications. However, there is significant inter-individual variation in the average serum 25(OH)D3 concentrations and also in the response to supplementation with vitamin D. Genetic and epigenetic factors have been suggested to be responsible for a large part of the variation, but currently there is little information about the health effects of the variation.

In our previous study (VitDmet, Clinicaltrials.gov NCT01479933) we showed that only half of the participants responded to the 5-month vitamin D3 supplementation of 40 µg/day or 80 µg/day as expected and that certain vitamin D receptor (VDR) target genes were suitable biomarkers for displaying the transcriptomic response of human tissues to vitamin D3 supplementation.

The purpose of the current study is to investigate whether a high-dose vitamin D3 oral bolus produces marked VDR target gene expression response and whether there is large inter-individual variation, as what was suggested with the 5-month lower-dose supplementation.

In the Trial 1, the subjects are randomized to receive either 2,000 micrograms (80 000 IU) of vitamin D3 (n=20) or placebo (n=10) in one day. Blood samples are collected for peripheral blood mononuclear cell isolation and serum 25(OH)D3 measurements at baseline and 24 h and 48 h and 30 days after the first dose. Blood samples are also collected for immunomarker analyses. In the Trial 2, the procedures of the Trial 1 are repeated in two subjects with known low and high serum 25(OH)D3 concentrations in order to investigate more specifically the impact of different starting levels of serum 25(OH)D3.

In February 2015, new subjects were recruited to enter the Trial 1 in order to increase the size of the study. All the new subjects received the 2,000 microgram bolus of vitamin D3, there were no new subjects in the placebo arm.

June 30, 2016. Change to protocol: There will be no Trial 2, but instead the blood samples obtained in the Trial 1 from up to six subjects will be used for the additional analyses. The subjects are selected based on the response to vitamin D supplementation in the Trial 1.

Study Type

Interventional

Enrollment (Actual)

35

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Finland
      • Kuopio, Finland, 70211
        • University of Eastern Finland

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Non-smoking
  • BMI 20-25 kg/m2.

Exclusion Criteria:

  • History of kidney stones, renal failure or dialysis, hypercalcemia, hypo- or hyperparathyroidism, severe liver disease (cirrhosis), or sarcoidosis or other granulomatous diseases, such as active chronic tuberculosis or Wegener's granulomatosis.
  • Continuous use of anti-inflammatory medicines.
  • Regular use of supplements containing vitamin D.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Vitamin D3
2000 micrograms of vitamin D3 in two doses during one day
Dietary supplement: Vitamin D3
In total 25 pills will be taken by the subjects, each containing 80 micrograms of vitamin D3 or placebo. Of the 25 pills, 13 will be taken in the morning with breakfast and 12 with lunch.
Other Names:
  • cholecalciferol
Placebo Comparator: Placebo
Placebo in two doses during one day
Dietary supplement: Placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change from baseline in vitamin D target gene expression
Time Frame: 24 h, 48 h, and 30 days after the baseline
Effect of 2000 microgram vitamin D3 dose or placebo on the expression of vitamin D receptor target genes
24 h, 48 h, and 30 days after the baseline

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change from baseline in serum 25(OH)D
Time Frame: 24 h, 48 h, and 30 days after the baseline
Effect of 2000 microgram vitamin D3 dose or placebo on serum 25(OH)D3 concentrations
24 h, 48 h, and 30 days after the baseline

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change from baseline in immunomarkers
Time Frame: 24 h, 48 h, and 30 days after the baseline
Effect of 2000 microgram Vitamin D3 dose or placebo on immune system and inflammatory responses, such as hs-CRP, IL-6, TNF-alfa and IL-1RA.
24 h, 48 h, and 30 days after the baseline
Change from baseline in glucose metabolism
Time Frame: 24 h, 48 h, and 30 days after the baseline
Effect of 2000 microgram vitamin D3 dose or placebo on glucose metabolism responses, i.e. blood glucose and insulin
24 h, 48 h, and 30 days after the baseline
Change from baseline in safety measurements
Time Frame: 48 h and 30 days after the baseline
Serum calcium, alanine transaminase (ALAT), gamma-glutamyl transferase (GGT) and creatinine
48 h and 30 days after the baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Eastern Finland

Investigators

  • Principal Investigator: Jyrki K Virtanen, PhD, University of Eastern Finland

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2014

Primary Completion (Actual)

June 1, 2015

Study Completion (Actual)

June 1, 2015

Study Registration Dates

First Submitted

February 4, 2014

First Submitted That Met QC Criteria

February 12, 2014

First Posted (Estimate)

February 14, 2014

Study Record Updates

Last Update Posted (Estimate)

July 29, 2016

Last Update Submitted That Met QC Criteria

July 28, 2016

Last Verified

June 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • VitDbol

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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