NCT01538485

Brief Summary

In this pilot study the investigators aim to investigate the effects of vitamin D supplementation on regulatory FoxP3+ T cells in the gastrointestinal mucosa in healthy women and men.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
16

participants targeted

Target at below P25 for phase_4

Timeline
Completed

Started Jan 2012

Shorter than P25 for phase_4

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2012

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

February 8, 2012

Completed
16 days until next milestone

First Posted

Study publicly available on registry

February 24, 2012

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2012

Completed
Last Updated

October 10, 2012

Status Verified

October 1, 2012

Enrollment Period

7 months

First QC Date

February 8, 2012

Last Update Submit

October 9, 2012

Conditions

Immune Tolerance

Keywords

Vitamin Dregulatory T cellsGUT

Outcome Measures

Primary Outcomes (1)

  • Increase of regulatory FOXP3+ T cells

    the effects of vitamin D on regulatory FOXP3+ T cells will be measured at basal and after 2 months

    2 months

Secondary Outcomes (2)

  • other immune cells in the gastrointestinal mucosa

    2 months

  • serum calcium level

    2 months

Study Arms (1)

Cholecalciferol

EXPERIMENTAL
Drug: Cholecalciferol

Interventions

CholecalciferolDRUG

weekly dose (based on 70IU KG body weight/day)

Also known as: Oleovit D3
Cholecalciferol

Eligibility Criteria

Age18 Years - 40 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • years
  • non smoker
  • BMI: 20-30 kg/m²
  • Healthy

You may not qualify if:

  • hypercalcemia \> 2,65 mmol/L
  • pregnancy
  • chronic diseases

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Medical university Graz

Graz, 8020, Austria

Location

MeSH Terms

Interventions

Cholecalciferol

Intervention Hierarchy (Ancestors)

CholestenesCholestanesSteroidsFused-Ring CompoundsPolycyclic CompoundsSterolsVitamin DSecosteroidsMembrane LipidsLipids

Study Officials

  • Thomas R. Pieber, Prof.

    Medical University of Graz

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NA
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 8, 2012

First Posted

February 24, 2012

Study Start

January 1, 2012

Primary Completion

August 1, 2012

Study Completion

August 1, 2012

Last Updated

October 10, 2012

Record last verified: 2012-10

Locations

AU(1)