Vitamin A and Response to Endotoxin | NCT00168649

Studies
Vitamin A and Response to Endotoxin

NCT00168649

Sponsor

Bandim Health Project

Status

Unknown status

Last Update Posted

Nov 15, 2013Estimated

Enrollment

Phase

Not Applicable

Conditions

TNF-alfa
Endotoxin Levels

Interventions

Vitamin A

Countries

Denmark

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
9583-2625

Status Module

Record Verification Date

Nov 2013

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Active, not recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 2005

Primary Completion Date

Not provided

Completion Date

Jun 2014

First Submitted Date

Sep 12, 2005

First Submission Date that Met QC Criteria

Sep 12, 2005

First Posted Date

Sep 15, 2005Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Nov 14, 2013

Last Update Posted Date

Nov 15, 2013Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Not provided

Lead Sponsor

Bandim Health ProjectOTHER

Collaborators

Name	Class
Uppsala University Hospital	OTHER
Institute for Human Nutrition, Royal Veterinary School, Copenhagen, Denmark	UNKNOWN

Description Module

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.

Detailed Description

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. As studies in children in low-income countries have indicated that vitamin A has long-term effects on the immune system, we furthermore wish to examine the long-term effects of vitamin A on the response to endotoxin. This will be done in an established model using infusion with endotoxin to male human volunteers. We hypothesise that vitamin A decreases endotoxin levels and TNF-alfa responses. Furthermore, we hypothesise that it reduces oxidative stress and injury.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

Name	Type	Description	Arm Group Labels	Other Names
Vitamin A	Drug

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Endotoxin levels
TNF-alfa levels

Secondary Outcomes

Measure	Description	Time Frame
Measures of oxidative injury and stress
Retinol and beta-caroten levels
Haematological values

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria: Healthy, male, between 18 and 35 years of age, non-smoker, no medicine, no infections in preceding 14 days

Exclusion Criteria:

Accepts Healthy Volunteers

Yes

Sex

Male

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

35 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Bente K Pedersen, MD, DMSc	Rigshospitalet, Denmark	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Rigshospitalet, Department M7641		Copenhagen		2100	Denmark

Intervention Browse Module

MeSH Terms

ID	Term
D014801	Vitamin A

Ancestor Terms

ID	Term
D012176	Retinoids
D002338	Carotenoids
D011090	Polyenes
D000475	Alkenes
D006839

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Browse Branches

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