NCT03537027

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P50-P75 for phase_1

Timeline
Completed

Started May 2018

Shorter than P25 for phase_1

Geographic Reach
1 country

1 active site

Status
completed

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

First Submitted

Initial submission to the registry

April 26, 2018

Completed
7 days until next milestone

Study Start

First participant enrolled

May 3, 2018

Completed
22 days until next milestone

First Posted

Study publicly available on registry

May 25, 2018

Completed
6 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 31, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 31, 2018

Completed
Last Updated

October 12, 2018

Status Verified

October 1, 2018

Enrollment Period

28 days

First QC Date

April 26, 2018

Last Update Submit

October 11, 2018

Conditions

Vitamin D Receptor Target Gene ExpressionSerum 25(OH)D Concentration

Keywords

vitamin D3cholecalciferolcalcidiol25-hydroxyvitamin Dgene expressionvitamin D receptoradultsclinical trial

Outcome Measures

Primary Outcomes (2)

  • In vivo change from baseline in vitamin D target gene expression in the subjects

    Effect of 2000 microgram vitamin D3 dose on the expression of vitamin D receptor target genes

    24 hours after the baseline

  • In vitro change from baseline in vitamin D target gene expression in peripheral blood mononuclear cells

    Effects of treatment of cells for 24 h with 100 nM of 25(OH)D3, 1 nM of 1,25(OH)2D3 or vehicle (solvent) on the expression of vitamin D receptor target genes

    24 hours after the baseline

Secondary Outcomes (5)

  • In vivo change from baseline in serum 25(OH)D concentration

    24 hours after the baseline

  • In vivo change from baseline in serum calcium concentration (safety and tolerability)

    24 hours after the baseline

  • In vivo change from baseline in serum alanine transaminase concentration (safety and tolerability)

    24 hours after the baseline

  • In vivo change from baseline in serum gamma-glutamyl transferase concentration (safety and tolerability)

    24 hours after the baseline

  • In vivo change from baseline in serum creatinine concentration (safety and tolerability)

    24 hours after the baseline

Study Arms (1)

Vitamin D3

EXPERIMENTAL

2000 micrograms of vitamin D3 in two doses during one day

Dietary Supplement: Vitamin D3

Interventions

Vitamin D3DIETARY_SUPPLEMENT

In total 20 pills will be taken by the subjects, each containing 100 micrograms of vitamin D3, resulting in the total amount of 2000 micrograms of vitamin D3. Of the 20 pills, 10 will be taken in the morning with breakfast and 10 with lunch.

Also known as: cholecalciferol
Vitamin D3

Eligibility Criteria

Age20 Years - 60 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

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 over 20 micrograms of vitamin D.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Eastern Finland

Kuopio, 70211, Finland

Location

MeSH Terms

Interventions

Cholecalciferol

Intervention Hierarchy (Ancestors)

CholestenesCholestanesSteroidsFused-Ring CompoundsPolycyclic CompoundsSterolsVitamin DSecosteroidsMembrane LipidsLipids

Study Officials

  • Carsten Carlberg, PhD

    University of Eastern Finland

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor of biochemistry

Study Record Dates

First Submitted

April 26, 2018

First Posted

May 25, 2018

Study Start

May 3, 2018

Primary Completion

May 31, 2018

Study Completion

May 31, 2018

Last Updated

October 12, 2018

Record last verified: 2018-10

Data Sharing

IPD Sharing
Will not share

Locations

FI(1)