Iron Deficiency AnemiaNCT03618914
Anemia and Inflammation
An observational study of Iron Deficiency Anemia and Inflammation, run by Swiss Federal Institute of Technology at 1 site in Morocco.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 49 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Iron Deficiency Anemia, Inflammation
- What is being tested?
- Dultavax and Vaxigrip
- Type of treatment
- Vaccines
- How many people
- 50 participants
- Where
- 1 siteMorocco
- Study dates
- 15 Sep 2017to 30 Jun 2018
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 49 years
- Women only
- Healthy volunteers accepted
- Adult
Study population: Young women with or without iron-deficiency anemia
Who may be able to join
- 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)
Who cannot join
- pregnant or lactating
- chronic disease
- smoking
- inflammation defined as CRP<5mg/L; AGP<1g/L
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Iron Deficiency Anemia, Inflammation
- Being tested
- Dultavax and Vaxigrip
- Medical subject headings
- Anemia, Iron-Deficiency, Inflammation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dultavax and VaxigripBiological
All the women got an influenza/DTP vaccine in order to induce acute inflammation
| Study group | Role | What they receive |
|---|---|---|
| Non-anemic women | Not described Receives: Biological: Dultavax and Vaxigrip | |
| anemic women | anemia due to iron deficiency Receives: Biological: Dultavax and Vaxigrip |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fractional and total iron absorption
Measured: 14 days after the second baseline test meal administration
Fractional and total iron absorption
Measured: 14 days after the test meal administered 24 hours after vaccination
Secondary outcomes (6)
Serum hepcidin
Measured: up to 36 hours
Serum Interleukin 6
inflammation
Measured: up to 36 hours
Serum ferritin
Iron status
Measured: up to 36 hours
Serum transferrin
Iron status
Measured: up to 36 hours
Serum CRP
inflammation
Measured: up to 36 hours
Serum AGP
inflammation
Measured: up to 36 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Aug 2018
- Study start15 Sep 2017
- Primary completion29 Mar 2018
- Study completion30 Jun 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Iron Deficiency AnemiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Swiss Federal Institute of Technology
- Sponsor type
- University, hospital or other
- Collaborators
- Ibn Tofail University-CNESTEN
- Responsible party
- Principal investigator, Prof. Michael B. Zimmermann, Swiss Federal Institute of Technology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03618914
- Sponsor's protocol ID
- SMILE Study
- Status last verified
- Aug 2018
- First submitted
- 23 Jul 2018
- Last updated
- 22 Aug 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Interactive Effects of Iron Status and Inflammation on Serum Hepcidin and Erythrocyte Iron Incorporation in Young Women
- ClinicalTrials.gov ID
- NCT03618914
- Acronym / sponsor ID
- SMILE Study
- Conditions
- Iron Deficiency Anemia, Inflammation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Swiss Federal Institute of TechnologyUniversity, hospital or other
- Collaborators
- Ibn Tofail University-CNESTEN
- Study start
- 15 Sep 2017 (actual)
- Primary completion
- 29 Mar 2018 (actual)
- Study completion
- 30 Jun 2018 (actual)
- First posted
- 7 Aug 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Non-anemic women | – | Biological: Dultavax and Vaxigrip |
| anemic women | – | Biological: Dultavax and Vaxigripanemia due to iron deficiency |
Who may qualify
- Ages
- 18 to 49 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Young women with or without iron-deficiency anemia
Key inclusion criteria (3 listed)
- 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)
Key exclusion criteria (4 listed)
- pregnant or lactating
- chronic disease
- smoking
- inflammation defined as CRP<5mg/L; AGP<1g/L
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Dultavax and VaxigripAll the women got an influenza/DTP vaccine in order to induce acute inflammation | Biological | Non-anemic women, anemic women |
Primary outcome
Fractional and total iron absorption
Time frame: 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
6 secondary outcomes
Serum hepcidin
Time frame: up to 36 hours
Serum Interleukin 6
Time frame: up to 36 hours
Serum ferritin
Time frame: up to 36 hours
Serum transferrin
Time frame: up to 36 hours
Serum CRP
Time frame: up to 36 hours
Serum AGP
Time frame: up to 36 hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Aug 2018.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Iron Deficiency Anemia and Inflammation, run by Swiss Federal Institute of Technology at 1 site in Morocco.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Aug 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Morocco. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Fractional and total iron absorption (time frame: 14 days after the second baseline test meal administration). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Aug 2018.