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Trial record 10 of 30 for:    high dose vitamin k

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

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ClinicalTrials.gov Identifier: NCT02063334
Recruitment Status : Completed
First Posted : February 14, 2014
Last Update Posted : July 29, 2016
Sponsor:
Information provided by (Responsible Party):
University of Eastern Finland

Tracking Information
First Submitted Date  ICMJE February 4, 2014
First Posted Date  ICMJE February 14, 2014
Last Update Posted Date July 29, 2016
Study Start Date  ICMJE February 2014
Actual Primary Completion Date June 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 12, 2014)
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
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: February 12, 2014)
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
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures
 (submitted: February 12, 2014)
  • 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.
  • 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
  • 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
Original Other Pre-specified Outcome Measures Same as current
 
Descriptive Information
Brief Title  ICMJE The Effect of a High-dose Oral Vitamin D3 Bolus on Serum 25(OH)D3 and Vitamin D Receptor Target Gene Expression
Official Title  ICMJE The Effect of a High-dose Oral Vitamin D3 Bolus on Serum 25-hydroxyvitamin D3 and Vitamin D Receptor Target Gene Expression (VitDbol)
Brief Summary 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.
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  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Basic Science
Condition  ICMJE
  • Vitamin D Receptor Target Gene Expression
  • Serum 25(OH)D Concentration
Intervention  ICMJE
  • 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
  • Dietary Supplement: Placebo
Study Arms  ICMJE
  • Active Comparator: Vitamin D3
    2000 micrograms of vitamin D3 in two doses during one day
    Intervention: Dietary Supplement: Vitamin D3
  • Placebo Comparator: Placebo
    Placebo in two doses during one day
    Intervention: Dietary Supplement: Placebo
Publications * Seuter S, Virtanen JK, Nurmi T, Pihlajamäki J, Mursu J, Voutilainen S, Tuomainen TP, Neme A, Carlberg C. Molecular evaluation of vitamin D responsiveness of healthy young adults. J Steroid Biochem Mol Biol. 2017 Nov;174:314-321. doi: 10.1016/j.jsbmb.2016.06.003. Epub 2016 Jun 6.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: December 2, 2015)
35
Original Estimated Enrollment  ICMJE
 (submitted: February 12, 2014)
32
Actual Study Completion Date  ICMJE June 2015
Actual Primary Completion Date June 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Finland
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02063334
Other Study ID Numbers  ICMJE VitDbol
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party University of Eastern Finland
Study Sponsor  ICMJE University of Eastern Finland
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Jyrki K Virtanen, PhD University of Eastern Finland
PRS Account University of Eastern Finland
Verification Date June 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP