NCT00168649

Brief Summary

Vitamin A given as treatment and pre-treatment has reduced the severity of symptoms after infusion with endotoxin in several animal models. We intend to examine the effect of vitamin A as pre-treatment on the response to endotoxin in humans. We furthermore wish to examine the long-term effects of vitamin A on the response to endotoxin. We hypothesise that vitamin A decreases endotoxin levels and TNF-alfa responses.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jun 2005

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

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

Study Start

First participant enrolled

June 1, 2005

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

September 12, 2005

Completed
3 days until next milestone

First Posted

Study publicly available on registry

September 15, 2005

Completed
8.7 years until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2014

Completed
Last Updated

November 15, 2013

Status Verified

November 1, 2013

First QC Date

September 12, 2005

Last Update Submit

November 14, 2013

Conditions

TNF-alfaEndotoxin Levels

Keywords

Vitamin AEndotoxinTNF-alfa

Outcome Measures

Primary Outcomes (2)

  • Endotoxin levels

  • TNF-alfa levels

Secondary Outcomes (4)

  • Measures of oxidative injury and stress

  • Retinol and beta-caroten levels

  • Haematological values

  • Clinical markers

Interventions

Vitamin ADRUG

Eligibility Criteria

Age18 Years - 35 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Rigshospitalet, Department M7641

Copenhagen, 2100, Denmark

Location

MeSH Terms

Interventions

Vitamin A

Intervention Hierarchy (Ancestors)

RetinoidsCarotenoidsPolyenesAlkenesHydrocarbons, AcyclicHydrocarbonsOrganic ChemicalsCyclohexenesCyclohexanesCycloparaffinsHydrocarbons, AlicyclicHydrocarbons, CyclicTerpenesDiterpenesPigments, BiologicalBiological Factors

Study Officials

  • Bente K Pedersen, MD, DMSc

    Rigshospitalet, Denmark

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

September 12, 2005

First Posted

September 15, 2005

Study Start

June 1, 2005

Study Completion

June 1, 2014

Last Updated

November 15, 2013

Record last verified: 2013-11

Locations

DK(1)