The Effect of a High-dose Oral Vitamin D3 Bolus on Serum 25(OH)D3 and Vitamin D Receptor Target Gene Expression
VitDbol
1 other identifier
interventional
35
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_1
Started Feb 2014
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 1, 2014
CompletedFirst Submitted
Initial submission to the registry
February 4, 2014
CompletedFirst Posted
Study publicly available on registry
February 14, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2015
CompletedJuly 29, 2016
June 1, 2016
1.3 years
February 4, 2014
July 28, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change from baseline in vitamin D target gene expression
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 Outcomes (1)
Change from baseline in serum 25(OH)D
24 h, 48 h, and 30 days after the baseline
Other Outcomes (3)
Change from baseline in immunomarkers
24 h, 48 h, and 30 days after the baseline
Change from baseline in glucose metabolism
24 h, 48 h, and 30 days after the baseline
Change from baseline in safety measurements
48 h and 30 days after the baseline
Study Arms (2)
Vitamin D3
ACTIVE COMPARATOR2000 micrograms of vitamin D3 in two doses during one day
Placebo
PLACEBO COMPARATORPlacebo in two doses during one day
Interventions
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.
Eligibility Criteria
You may qualify if:
- Non-smoking
- BMI 20-25 kg/m2.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University of Eastern Finland
Kuopio, 70211, Finland
Related Publications (1)
Seuter S, Virtanen JK, Nurmi T, Pihlajamaki 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.
PMID: 27282116DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Jyrki K Virtanen, PhD
University of Eastern Finland
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- BASIC SCIENCE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 4, 2014
First Posted
February 14, 2014
Study Start
February 1, 2014
Primary Completion
June 1, 2015
Study Completion
June 1, 2015
Last Updated
July 29, 2016
Record last verified: 2016-06