Clinical trial · Interventional
The Effect of a High-dose Oral Vitamin D3 Bolus on Serum 25(OH)D3 and Vitamin D Receptor Target Gene Expression
The Effect of a High-dose Oral Vitamin D3 Bolus on Serum 25-hydroxyvitamin D3 and Vitamin D Receptor Target Gene Expression (VitDbol)
NCT02063334CI-TRIAL-00023288VitDbolcompletedPhase 1ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Serum 25(OH)D Concentration | — | UNRESOLVED | — |
| Vitamin D Receptor Target Gene Expression | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Placebo | Dietary Supplement | — | UNRESOLVED |
| Vitamin D3 | Dietary Supplement | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- Vitamin D3
- description
- 2000 micrograms of vitamin D3 in two doses during one day
- interventionNames
- Dietary Supplement: Vitamin D3
- type
- PLACEBO_COMPARATOR
- label
- Placebo
- description
- Placebo in two doses during one day
- interventionNames
- Dietary Supplement: Placebo
Primary outcomes (1)
- measure
- Change from baseline in vitamin D target gene expression
- timeFrame
- 24 h, 48 h, and 30 days after the baseline
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (1)
- DERIVEDSeuter 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 27282116