Interactive Effects of Iron Status and Inflammation on Serum Hepcidin and Erythrocyte Iron Incorporation in Young Women
Anemia and Inflammation
Sponsors
Source
Swiss Federal Institute of Technology
Oversight Info
Has Dmc
No
Is Fda Regulated Drug
No
Is Fda Regulated Device
No
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.
Overall Status
Completed
Start Date
2017-09-15
Completion Date
2018-06-30
Primary Completion Date
2018-03-29
Study Type
Observational
Primary Outcome
Measure |
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 Outcome
Measure |
Time Frame |
|
Serum hepcidin |
up to 36 hours |
|
Serum Interleukin 6 |
up to 36 hours |
|
Serum ferritin |
up to 36 hours |
|
Serum transferrin |
up to 36 hours |
|
Serum CRP |
up to 36 hours |
|
Serum AGP |
up to 36 hours |
Number Of Groups
2
Enrollment
50
Conditions
Intervention
Intervention Type
Biological
Intervention Name
Description
All the women got an influenza/DTP vaccine in order to induce acute inflammation
Arm Group Label
Non-anemic women
anemic women
Eligibility
Study Pop
Young women with or without iron-deficiency anemia
Sampling Method
Non-Probability Sample
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
Gender
Female
Minimum Age
18 Years
Maximum Age
49 Years
Healthy Volunteers
Accepts Healthy Volunteers
Location
Facility |
|
Ibn Tofail University-CNESTEN Rabat Morocco |
Location Countries
Country
Morocco
Verification Date
2018-08-01
Lastchanged Date
N/A
Firstreceived Date
N/A
Responsible Party
Responsible Party Type
Principal Investigator
Investigator Affiliation
Swiss Federal Institute of Technology
Investigator Full Name
Prof. Michael B. Zimmermann
Investigator Title
Prof. Dr. med.
Has Expanded Access
No
Condition Browse
Arm Group
Arm Group Label
Non-anemic women
Arm Group Label
anemic women
Description
anemia due to iron deficiency
Firstreceived Results Date
N/A
Biospec Retention
Samples Without DNA
Biospec Descr
Serum Samples
Patient Data
Sharing Ipd
No
Firstreceived Results Disposition Date
N/A
Study Design Info
Observational Model
Case-Only
Time Perspective
Prospective
Study First Submitted
July 23, 2018
Study First Submitted Qc
August 6, 2018
Study First Posted
August 7, 2018
Last Update Submitted
August 20, 2018
Last Update Submitted Qc
August 20, 2018
Last Update Posted
August 22, 2018
ClinicalTrials.gov processed this data on December 06, 2019
Conditions
Conditions usually refer to a disease, disorder, syndrome, illness, or injury. In ClinicalTrials.gov,
conditions include any health issue worth studying, such as lifespan, quality of life, health risks, etc.
Interventions
Interventions refer to the drug, vaccine, procedure, device, or other potential treatment being studied.
Interventions can also include less intrusive possibilities such as surveys, education, and interviews.
Study Phase
Most clinical trials are designated as phase 1, 2, 3, or 4, based on the type of questions
that study is seeking to answer:
In Phase 1 (Phase I) clinical trials, researchers test a new drug or treatment in a small group of people (20-80) for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
In Phase 2 (Phase II) clinical trials, the study drug or treatment is given to a larger group of people (100-300) to see if it is effective and to further evaluate its safety.
In Phase 3 (Phase III) clinical trials, the study drug or treatment is given to large groups of people (1,000-3,000) to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
In Phase 4 (Phase IV) clinical trials, post marketing studies delineate additional information including the drug's risks, benefits, and optimal use.
These phases are defined by the Food and Drug Administration in the Code of Federal Regulations.
In Phase 1 (Phase I) clinical trials, researchers test a new drug or treatment in a small group of people (20-80) for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
In Phase 2 (Phase II) clinical trials, the study drug or treatment is given to a larger group of people (100-300) to see if it is effective and to further evaluate its safety.
In Phase 3 (Phase III) clinical trials, the study drug or treatment is given to large groups of people (1,000-3,000) to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
In Phase 4 (Phase IV) clinical trials, post marketing studies delineate additional information including the drug's risks, benefits, and optimal use.
These phases are defined by the Food and Drug Administration in the Code of Federal Regulations.