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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
University of Eastern Finland
ClinicalTrials.gov Identifier:
NCT02063334
First received: February 4, 2014
Last updated: June 12, 2014
Last verified: June 2014
  Purpose

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.


Condition Intervention Phase
Vitamin D Receptor Target Gene Expression
Serum 25(OH)D Concentration
Dietary Supplement: Vitamin D3
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacokinetics/Dynamics Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Basic Science
Official Title: The Effect of a High-dose Oral Vitamin D3 Bolus on Serum 25-hydroxyvitamin D3 and Vitamin D Receptor Target Gene Expression (VitDbol)

Resource links provided by NLM:


Further study details as provided by University of Eastern Finland:

Primary Outcome Measures:
  • Change from baseline in vitamin D target gene expression [ Time Frame: 24 h, 48 h, and 30 days after the baseline ] [ Designated as safety issue: No ]
    Effect of 2000 microgram vitamin D3 dose or placebo on the expression of vitamin D receptor target genes


Secondary Outcome Measures:
  • Change from baseline in serum 25(OH)D [ Time Frame: 24 h, 48 h, and 30 days after the baseline ] [ Designated as safety issue: Yes ]
    Effect of 2000 microgram vitamin D3 dose or placebo on serum 25(OH)D3 concentrations


Other Outcome Measures:
  • Change from baseline in immunomarkers [ Time Frame: 24 h, 48 h, and 30 days after the baseline ] [ Designated as safety issue: Yes ]
    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.

  • Change from baseline in glucose metabolism [ Time Frame: 24 h, 48 h, and 30 days after the baseline ] [ Designated as safety issue: Yes ]
    Effect of 2000 microgram vitamin D3 dose or placebo on glucose metabolism responses, i.e. blood glucose and insulin

  • Change from baseline in safety measurements [ Time Frame: 48 h and 30 days after the baseline ] [ Designated as safety issue: Yes ]
    Serum calcium, alanine transaminase (ALAT), gamma-glutamyl transferase (GGT) and creatinine


Enrollment: 22
Study Start Date: February 2014
Primary Completion Date: May 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: cholecalciferol
Placebo Comparator: Placebo
Placebo in two doses during one day

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02063334

Locations
Finland
University of Eastern Finland
Kuopio, Finland, 70211
Sponsors and Collaborators
University of Eastern Finland
Investigators
Principal Investigator: Jyrki K Virtanen, PhD University of Eastern Finland
  More Information

No publications provided

Responsible Party: University of Eastern Finland
ClinicalTrials.gov Identifier: NCT02063334     History of Changes
Other Study ID Numbers: VitDbol
Study First Received: February 4, 2014
Last Updated: June 12, 2014
Health Authority: Finland: Ethics Committee

Keywords provided by University of Eastern Finland:
vitamin D3
cholecalciferol
calcidiol
25-hydroxyvitamin D
gene expression
vitamin D receptor
randomized controlled trial
men
adults

Additional relevant MeSH terms:
Calcifediol
Cholecalciferol
Vitamin D
Ergocalciferols
Hydroxycholecalciferols
Vitamins
Micronutrients
Growth Substances
Physiological Effects of Drugs
Pharmacologic Actions
Bone Density Conservation Agents

ClinicalTrials.gov processed this record on August 26, 2014