Anemia and Inflammation

Inflammation Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03618914
• Other study ID #: SMILE Study
• Status: Completed
• Start date: September 15, 2017
• Est. completion date: June 30, 2018

Study information

• Verified date: August 2018
• Source: Swiss Federal Institute of Technology
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: June 30, 2018
• Est. primary completion date: March 29, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 49 Years

Eligibility

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

Related Conditions & MeSH terms

• Anemia
• Anemia, Iron-Deficiency
• Inflammation
• Iron Deficiency Anemia

Intervention

Biological:
• Dultavax and Vaxigrip
All the women got an influenza/DTP vaccine in order to induce acute inflammation

Locations

Country	Name	City	State
Morocco	Ibn Tofail University-CNESTEN	Rabat

Sponsors (2)

Lead Sponsor	Collaborator
Swiss Federal Institute of Technology	Ibn Tofail University-CNESTEN

Country where clinical trial is conducted

Morocco, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Fractional and total iron absorption		14 days after the second baseline test meal administration
Primary	Fractional and total iron absorption		14 days after the test meal administered 24 hours after vaccination
Secondary	Serum hepcidin		up to 36 hours
Secondary	Serum Interleukin 6	inflammation	up to 36 hours
Secondary	Serum ferritin	Iron status	up to 36 hours
Secondary	Serum transferrin	Iron status	up to 36 hours
Secondary	Serum CRP	inflammation	up to 36 hours
Secondary	Serum AGP	inflammation	up to 36 hours