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OpenTrials
Completed

NCT Number: NCT03623997

Measuring Erythrocyte Iron Incorporation From Different Dosing Regimens in Anemic Women

Iron-deficient anaemic subjects are likely to benefit most from oral iron supplements, but supplementation schedules vary widely in clinical practice, absorption is low and compliance is poor due to mild gastrointestinal side effects. The investigators will compare iron absorption from labeled oral iron doses of 100mg and 200mg administered either on two consecutive days or on alternate days in young anemic women.

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Key information

Conditions

Iron Deficiency Anemia Anemia Anemia, Hypochromic Anemia, Iron-Deficiency Hematologic Diseases Hemic and Lymphatic Diseases Iron Deficiencies Iron Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year–45 year

Sex eligibility

Female

Study type

Observational

Primary location

Human Nutrition Laboratory ETH Zurich

Zurich, 8092, Switzerland

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Ferritin <15 µg/L
  • Hb 8-11.9 g/dl
  • BMI 18.5-24.9 kg/m2
  • Body weight <70 kg

Exclusion criteria

  • Severe anemia (Hb <8 g/dl)
  • Elevated CRP >5.0 mg/L
  • Chronic disease
  • Long-term medication, except contraception
  • Consumption of Mineral and Vitamin supplements within the study period
  • Therapeutic iron infusion over the past 6 months
  • Pregnancy or breastfeeding
  • Smoking

Treatment and study plan

Iron stable isotope labeled iron(II) sulfate

Other

Administration of oral stable isotope labels using different dosings and different regimens in women with iron deficiency anemia

Primary outcomes

  1. Fractional and total iron absorption

    Time frame: absorption will be measured 14days after the 100mg and 200mg cycle

    Fractional and total iron absorption from different supplementation regimens

  2. Serum hepcidin

    Time frame: right before the administration of an iron dose

    Serum hepcidin after the administration of different doses and using different regimens

  3. Serum EPO

    Time frame: right before the administration of an iron dose

    Serum EPO after the administration of different doses and using different

Secondary outcomes

  1. Serum ferritin

    Time frame: right before the administration of an iron dose

    Determination of iron status

  2. Serum TfR

    Time frame: right before the administration of an iron dose

    Determination of iron status

  3. Serum CRP

    Time frame: right before the administration of an iron dose

    Determination of inflammation status

  4. Serum AGP

    Time frame: right before the administration of an iron dose

    Determination of inflammation status

  5. Serum iron

    Time frame: right before the administration of an iron dose

    Determination of iron status

  6. Total iron binding capacity

    Time frame: right before the administration of an iron dose

    Determination of iron status

Sponsors and collaborators

Lead sponsor

Swiss Federal Institute of Technology

Other

Registry information

Official study title

Defining Systemic Control of Iron Absorption to Optimize Oral Iron Supplementation Regiemns for Women With Iron Deficiency Anemia

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Aug 9, 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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