Anemia and Inflammation

August 20, 2018 updated by: Prof. Michael B. Zimmermann, Swiss Federal Institute of Technology

Interactive Effects of Iron Status and Inflammation on Serum Hepcidin and Erythrocyte Iron Incorporation in Young Women

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

50

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Morocco
      • Rabat, Morocco
        • Ibn Tofail University-CNESTEN

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 47 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Sampling Method

Non-Probability Sample

Study Population

Young women with or without iron-deficiency anemia

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Only
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Non-anemic women
Biological: Dultavax and Vaxigrip
All the women got an influenza/DTP vaccine in order to induce acute inflammation
anemic women
anemia due to iron deficiency
Biological: Dultavax and Vaxigrip
All the women got an influenza/DTP vaccine in order to induce acute inflammation

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Serum hepcidin
Time Frame: up to 36 hours
up to 36 hours
Serum Interleukin 6
Time Frame: up to 36 hours
inflammation
up to 36 hours
Serum ferritin
Time Frame: up to 36 hours
Iron status
up to 36 hours
Serum transferrin
Time Frame: up to 36 hours
Iron status
up to 36 hours
Serum CRP
Time Frame: up to 36 hours
inflammation
up to 36 hours
Serum AGP
Time Frame: up to 36 hours
inflammation
up to 36 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Swiss Federal Institute of Technology

Collaborators

Ibn Tofail University-CNESTEN

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 15, 2017

Primary Completion (Actual)

March 29, 2018

Study Completion (Actual)

June 30, 2018

Study Registration Dates

First Submitted

July 23, 2018

First Submitted That Met QC Criteria

August 6, 2018

First Posted (Actual)

August 7, 2018

Study Record Updates

Last Update Posted (Actual)

August 22, 2018

Last Update Submitted That Met QC Criteria

August 20, 2018

Last Verified

August 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SMILE Study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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