Anemia and Inflammation | NCT03618914

Studies
Anemia and Inflammation

NCT03618914

Sponsor

Swiss Federal Institute of Technology

Status

Completed

Last Update Posted

Aug 22, 2018Actual

Enrollment

50Actual

Phase

Not provided

Conditions

Iron Deficiency Anemia
Inflammation

Interventions

Dultavax and Vaxigrip

Countries

Morocco

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

Status Module

Record Verification Date

Aug 2018

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 15, 2017Actual

Primary Completion Date

Mar 29, 2018Actual

Completion Date

Jun 30, 2018Actual

First Submitted Date

Jul 23, 2018

First Submission Date that Met QC Criteria

Aug 6, 2018

First Posted Date

Aug 7, 2018Actual

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

Aug 20, 2018

Last Update Posted Date

Aug 22, 2018Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Prof. Michael B. Zimmermann, Prof. Dr. med., Swiss Federal Institute of TechnologyPrincipal Investigator

Lead Sponsor

Swiss Federal Institute of TechnologyOTHER

Collaborators

Name	Class
Ibn Tofail University-CNESTEN	UNKNOWN

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

During inflammation hepcidin concentrations are increased, leading to a decrease in iron absorption. In iron deficiency anemia hepcidin is suppressed due to the activation of erythropoiesis. Whether inflammation or anemia has the stronger effect on hepcidin is uncertain.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

50Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Non-anemic women			Biological: Dultavax and Vaxigrip
anemic women		anemia due to iron deficiency	Biological: Dultavax and Vaxigrip

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Dultavax and Vaxigrip	Biological	All the women got an influenza/DTP vaccine in order to induce acute inflammation	Non-anemic women anemic women

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Fractional and total iron absorption		14 days after the second baseline test meal administration
Fractional and total iron absorption		14 days after the test meal administered 24 hours after vaccination

Secondary Outcomes

Measure	Description	Time Frame
Serum hepcidin		up to 36 hours
Serum Interleukin 6	inflammation	up to 36 hours
Serum ferritin

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

BMI <27.5kg/m2
body weight <70kg
either non-anemic (Hb>12.5g/dl) or anemic (Hb between 8-12 g/dl and ferritin <15ng/ml)

Exclusion Criteria:

pregnant or lactating
chronic disease
smoking
inflammation defined as CRP<5mg/L; AGP<1g/L

Accepts Healthy Volunteers

Yes

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

49 Years

Standard Ages

Adult

Study Population

Young women with or without iron-deficiency anemia

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Ibn Tofail University-CNESTEN		Rabat			Morocco

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D018798	Anemia, Iron-Deficiency
D007249	Inflammation

Ancestor Terms

ID	Term
D000747	Anemia, Hypochromic
D000740	Anemia
D006402	Hematologic Diseases
D006425	Hemic and Lymphatic Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
C478242	vaxigrip

Ancestor Terms

Not provided

Browse Leaves

Not provided

Browse Branches

Not provided