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Measuring Erythrocyte Iron Incorporation From Different Dosing Regimens in Anemic Women

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03623997
Recruitment Status : Completed
First Posted : August 9, 2018
Last Update Posted : August 22, 2018
Sponsor:
Information provided by (Responsible Party):
Prof. Michael B. Zimmermann, Swiss Federal Institute of Technology

Brief Summary:
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.

Condition or disease Intervention/treatment
Iron Deficiency Anemia Other: Iron stable isotope labeled iron(II) sulfate

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Study Type : Observational
Actual Enrollment : 20 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Defining Systemic Control of Iron Absorption to Optimize Oral Iron Supplementation Regiemns for Women With Iron Deficiency Anemia
Actual Study Start Date : October 10, 2017
Actual Primary Completion Date : January 8, 2018
Actual Study Completion Date : June 30, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Anemia Iron

Group/Cohort Intervention/treatment
Stable isotope labeled iron II sulfate
All subjects will go through two iron absorption study cycles. In one cycle they get 100mg oral iron labeled with stable isotopes on two consecutive and on one alternate day and in another cycle they get 200mg oral iron labeled with stable isotopes on two consecutive and on one alternate day. Half of the subjects start with the 100mg cycle whereas the other half starts with the 200mg cycle.
Other: Iron stable isotope labeled iron(II) sulfate
Administration of oral stable isotope labels using different dosings and different regimens in women with iron deficiency anemia




Primary Outcome Measures :
  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 Outcome Measures :
  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



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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Young women with iron-deficiency anemia
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03623997


Locations
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Switzerland
Human Nutrition Laboratory ETH Zurich
Zurich, Switzerland, 8092
Sponsors and Collaborators
Swiss Federal Institute of Technology
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Prof. Michael B. Zimmermann, Prof. Dr. med, Swiss Federal Institute of Technology
ClinicalTrials.gov Identifier: NCT03623997    
Other Study ID Numbers: FeSupp_Anemia
First Posted: August 9, 2018    Key Record Dates
Last Update Posted: August 22, 2018
Last Verified: August 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Anemia
Anemia, Iron-Deficiency
Hematologic Diseases
Anemia, Hypochromic
Iron Metabolism Disorders
Metabolic Diseases