Serum 25(OH)D Concentration Clinical Trial
Official title:
Comparing the Efficiency of Vitamin D3 and 25-hydroxyvitamin D3 Treatment on Changes of the Transcriptome of Low Vitamin D Responders
The purpose of the study is to investigate in vivo 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. These effects are compared to in vitro treatment of peripheral blood mononuclear cells from these subjects with 25(OH)D.
Serum 25-hydroxyvitamin D3 [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 studies VitDmet (Clinicaltrials.gov NCT01479933) and VitDbol
(Clinicaltrials.gov NCT02063334) we showed that the participants can be classified into high,
mid and low responders to vitamin D and defined the new biomarker "vitamin D response index".
Some 25% of the population seem to be low responders and are under higher risk to suffer from
insufficient supplementation with vitamin D. The current study will focus on low vitamin D
responders (among the 40 healthy individuals recruited in the study, 20-60 years old), i.e.
it will use the same oral vitamin D3 bolus (2,000 µg, i.e. 80,000 IU in one day) as in our
VitDbol study, in order to identify low vitamin D responders.
By in vitro treatment of peripheral blood mononuclear cells (PBMCs) of low responders with
25(OH)D3 for 24 h (in comparison to in vitro stimulations with 1,25-dihydroxyvitamin D3
[1,25(OH)2D3] and in vivo vitamin D3 supplementation of the same subjects) we will obtain
samples that allow the transcriptome-wide investigation of changes in gene expression. The
underlying hypothesis of this study is that a stimulation with 25(OH)D3 is more efficient
than a treatment with vitamin D3, so that in future low vitamin D responders may be
supplemented with 25(OH)D3 rather than with vitamin D3.
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| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT02063334 -
The Effect of a High-dose Oral Vitamin D3 Bolus on Serum 25(OH)D3 and Vitamin D Receptor Target Gene Expression
|
Phase 1 |