A Phase 1 interventional study of Vitamin D3 and Placebo in Vitamin D Receptor Target Gene Expression and Serum 25(OH)D Concentration, sponsored by University of Eastern Finland. Completed at 1 site in Finland. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2016-07-29.
Sponsored by University of Eastern Finland · Phase 1, Interventional, and Basic science
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.
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.
University of Eastern Finland is the lead sponsor of 51 studies on the registry; 9 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
2000 micrograms of vitamin D3 in two doses during one day
Dietary Supplement: Vitamin D3
Placebo in two doses during one day
Dietary Supplement: Placebo
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.
Also known as: cholecalciferol
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
Time frame: 24 h, 48 h, and 30 days after the baseline
Change from baseline in serum 25(OH)D
Effect of 2000 microgram vitamin D3 dose or placebo on serum 25(OH)D3 concentrations
Time frame: 24 h, 48 h, and 30 days after the baseline
Change from baseline in immunomarkers
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.
Time frame: 24 h, 48 h, and 30 days after the baseline
Change from baseline in glucose metabolism
Effect of 2000 microgram vitamin D3 dose or placebo on glucose metabolism responses, i.e. blood glucose and insulin
Time frame: 24 h, 48 h, and 30 days after the baseline
Change from baseline in safety measurements
Serum calcium, alanine transaminase (ALAT), gamma-glutamyl transferase (GGT) and creatinine
Time frame: 48 h and 30 days after the baseline
This study is completed, as verified in Jun 2016. You cannot join it, but the record below documents what was studied.
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University of Eastern Finland