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Completed

NCT Number: NCT03618914

Anemia and Inflammation

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.

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Key information

Conditions

Iron Deficiency Anemia Anemia Anemia, Hypochromic Anemia, Iron-Deficiency Hematologic Diseases Hemic and Lymphatic Diseases Inflammation Iron Deficiencies Iron Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year–49 year

Sex eligibility

Female

Study type

Observational

Primary location

Ibn Tofail University-CNESTEN

Rabat, Morocco

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Dultavax and Vaxigrip

Biological

All the women got an influenza/DTP vaccine in order to induce acute inflammation

Primary outcomes

  1. Fractional and total iron absorption

    Time frame: 14 days after the second baseline test meal administration

  2. Fractional and total iron absorption

    Time frame: 14 days after the test meal administered 24 hours after vaccination

Secondary outcomes

  1. Serum hepcidin

    Time frame: up to 36 hours

  2. Serum Interleukin 6

    Time frame: up to 36 hours

    inflammation

  3. Serum ferritin

    Time frame: up to 36 hours

    Iron status

  4. Serum transferrin

    Time frame: up to 36 hours

    Iron status

  5. Serum CRP

    Time frame: up to 36 hours

    inflammation

  6. Serum AGP

    Time frame: up to 36 hours

    inflammation

Sponsors and collaborators

Lead sponsor

Swiss Federal Institute of Technology

Other

Collaborators

  • Ibn Tofail University-CNESTEN

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Aug 7, 2018
Registry last updated
Aug 22, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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