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Defining a Dosing Regimen With Maximal Absorption for Oral Iron Supplementation During Pregnancy

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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04074707
Recruitment Status : Not yet recruiting
First Posted : August 30, 2019
Last Update Posted : August 30, 2019
Sponsor:
Collaborator:
Mahidol University
Information provided by (Responsible Party):
Prof. Michael B. Zimmermann, Swiss Federal Institute of Technology

Brief Summary:

Iron deficiency anemia (IDA) is common during pregnancy and has adverse effects on the mother, fetus and newborn. Oral iron supplements are usually recommended to prevent ID/IDA during pregnancy.

The aim of this study is to define an iron supplementation schedule with maximal absorption using serum hepcidin profiles and stable iron isotopes in pregnant women. In this randomized, open-label trial, fractional and total iron absorption will be compared from daily dosing with 60 mg iron versus alternate day and every third day dosing with 120 mg iron in pregnant Thai women with low iron stores (n=28) during their second trimester of pregnancy.

This study could have wide impact, providing the evidence base for revised, improved recommendations for iron supplementation during pregnancy.


Condition or disease Intervention/treatment Phase
Iron Deficiency Anemia of Pregnancy Dietary Supplement: Labeled iron solution (60mg and 120mg Ferrous Sulfate) Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 28 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description: each subject acts as her own control by going through all the three supplementation cycles. Women will be randomly assigned to start with the daily, every other day or every third day supplementation cycle.
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Optimizing Oral Iron Supplementation Regimens During Pregnancy Using Serum Hepcidin Profiles and Iron Stable Isotopes: Defining a Dosing Regimen With Maximal Absorption and Minimal Gastrointestinal Side Effects
Estimated Study Start Date : September 2019
Estimated Primary Completion Date : December 2019
Estimated Study Completion Date : December 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Anemia Iron

Arm Intervention/treatment
Experimental: oral iron supplementation
Participants go through 3 cycles of oral iron Supplementation (daily dosing, alternate-day dosing, every third-day dosing)
Dietary Supplement: Labeled iron solution (60mg and 120mg Ferrous Sulfate)
3 doses of 60mg iron as FeSO4 are given on 3 consecutive days (e.g., days 1-3); 3 doses of 120mg iron as FeSO4 are given on one consecutive and one alternate day (e.g., days 20, 21, 23); 3 doses of 120mg iron as FeSO4 are given on one consecutive and one 3rd day (e.g., days 37, 38, 41). Iron doses are labeled with 4mg of a stable isotope in 100ml deionized water (57Fe, 58Fe or 54Fe). Participants will be randomly assigned to start with daily, alternate-day or every-third day dosing.




Primary Outcome Measures :
  1. Fractional iron absorption in % [ Time Frame: Day 17 ]
    Erythrocyte incorporation of stable iron isotopes 14 days after the last supplement intake of the consecutive day cycle

  2. Fractional iron absorption in % [ Time Frame: Day 34 ]
    Erythrocyte incorporation of stable iron isotopes 14 days after the last supplement intake of the alternate day cycle

  3. Fractional iron absorption in % [ Time Frame: Day 52 ]
    Erythrocyte incorporation of stable iron isotopes 14 days after the last supplement intake of the every third day cycle

  4. Total iron absorption in % [ Time Frame: Day 17 ]
    Fractional iron absorption measured from consecutive day cycle multiplied by the dose

  5. Total iron absorption in % [ Time Frame: Day 34 ]
    Fractional iron absorption measured from alternate day cycle multiplied by the dose

  6. Total iron absorption in % [ Time Frame: Day 52 ]
    Fractional iron absorption measured from every third day cycle multiplied by the dose

  7. Serum Hepcidin [ Time Frame: Day 0 ]
    in the morning a day before first supplement intake of consecutive day cycle

  8. Serum Hepcidin [ Time Frame: Day 1 ]
    in the morning before first supplement intake of consecutive day cycle

  9. Serum Hepcidin [ Time Frame: Day 2 ]
    in the morning before second supplement intake of consecutive day cycle

  10. Serum Hepcidin [ Time Frame: Day 3 ]
    in the morning before third supplement intake of consecutive day cycle

  11. Serum Hepcidin [ Time Frame: Day 17 ]
    in the morning before first supplement intake of alternate day cycle

  12. Serum Hepcidin [ Time Frame: Day 18 ]
    in the morning before second supplement intake of alternate day cycle

  13. Serum Hepcidin [ Time Frame: Day 20 ]
    in the morning before third supplement intake of alternate day cycle

  14. Serum Hepcidin [ Time Frame: Day 34 ]
    in the morning before first supplement intake of every third day cycle

  15. Serum Hepcidin [ Time Frame: Day 35 ]
    in the morning before second supplement intake of every third day cycle

  16. Serum Hepcidin [ Time Frame: Day 38 ]
    in the morning before third supplement intake of every third day cycle

  17. Serum Hepcidin [ Time Frame: Day 52 ]
    in the morning 14 days after last supplement intake of every third day cycle


Secondary Outcome Measures :
  1. Serum Ferritin (SF) [ Time Frame: Day 0 ]
    in the morning 1 day before first supplement intake of consecutive day cycle

  2. Serum Ferritin (SF) [ Time Frame: Day 1 ]
    in the morning before first supplement intake of consecutive day cycle

  3. Serum Ferritin (SF) [ Time Frame: Day 17 ]
    in the morning before first supplement intake of alternate day cycle

  4. Serum Ferritin (SF) [ Time Frame: Day 34 ]
    in the morning before first supplement intake of every third day cycle

  5. Serum Ferritin (SF) [ Time Frame: Day 52 ]
    in the morning 14 days after last supplement intake of every third day

  6. Hemoglobin (Hb) [ Time Frame: Day 0 ]
    in the morning 1 day before first supplement intake of consecutive day cycle

  7. Hemoglobin (Hb) [ Time Frame: Day 1 ]
    in the morning before first supplement intake of consecutive day cycle

  8. Hemoglobin (Hb) [ Time Frame: Day 17 ]
    in the morning before first supplement intake of alternate day cycle

  9. Hemoglobin (Hb) [ Time Frame: Day 34 ]
    in the morning before first supplement intake of every third day cycle

  10. Hemoglobin (Hb) [ Time Frame: Day 52 ]
    in the morning 14 days after last supplement intake of every third day cycle

  11. Soluble transferrin receptor (sTfR) [ Time Frame: Day 0 ]
    in the morning 1 day before first supplement intake of consecutive day cycle

  12. Soluble transferrin receptor (sTfR) [ Time Frame: Day 1 ]
    in the morning before first supplement intake of consecutive day cycle

  13. Soluble transferrin receptor (sTfR) [ Time Frame: Day 17 ]
    in the morning before first supplement intake of alternate day cycle

  14. Soluble transferrin receptor (sTfR) [ Time Frame: Day 34 ]
    in the morning before first supplement intake of every third day cycle

  15. Soluble transferrin receptor (sTfR) [ Time Frame: Day 52 ]
    in the morning 14 days after last supplement intake of every third day cycle

  16. C-reactive protein (CRP) [ Time Frame: Day 0 ]
    in the morning 1 day before first supplement intake of consecutive day cycle

  17. C-reactive protein (CRP) [ Time Frame: Day 1 ]
    in the morning before first supplement intake of consecutive day cycle

  18. C-reactive protein (CRP) [ Time Frame: Day 17 ]
    in the morning before first supplement intake of alternate day cycle

  19. C-reactive protein (CRP) [ Time Frame: Day 34 ]
    in the morning before first supplement intake of every third day cycle

  20. C-reactive protein (CRP) [ Time Frame: Day 52 ]
    in the morning 14 days after last supplement intake of every third day cycle

  21. Alpha-1-acid glycoprotein (AGP) [ Time Frame: Day 0 ]
    in the morning 1 day before first supplement intake of consecutive day cycle

  22. Alpha-1-acid glycoprotein (AGP) [ Time Frame: Day 1 ]
    in the morning before first supplement intake of consecutive day cycle

  23. Alpha-1-acid glycoprotein (AGP) [ Time Frame: Day 17 ]
    in the morning before first supplement intake of alternate day cycle

  24. Alpha-1-acid glycoprotein (AGP) [ Time Frame: Day 34 ]
    in the morning before first supplement intake of every third day cycle

  25. Alpha-1-acid glycoprotein (AGP) [ Time Frame: Day 52 ]
    in the morning 14 days after last supplement intake of every third day cycle

  26. Serum Hepcidin [ Time Frame: Day 0 ]
    in the afternoon a day before first supplement intake of consecutive day cycle

  27. Serum Hepcidin [ Time Frame: Day 1 ]
    in the afternoon after first supplement intake of consecutive day cycle

  28. Serum Hepcidin [ Time Frame: Day 2 ]
    in the afternoon after second supplement intake of consecutive day cycle

  29. Serum Hepcidin [ Time Frame: Day 3 ]
    in the afternoon after third supplement intake of consecutive day cycle

  30. Serum Hepcidin [ Time Frame: Day 17 ]
    in the afternoon after first supplement intake of alternate day cycle

  31. Serum Hepcidin [ Time Frame: Day 18 ]
    in the afternoon after second supplement intake of alternate day cycle

  32. Serum Hepcidin [ Time Frame: Day 20 ]
    in the afternoon after third supplement intake of alternate day cycle

  33. Serum Hepcidin [ Time Frame: Day 34 ]
    in the afternoon after first supplement intake of every third day cycle

  34. Serum Hepcidin [ Time Frame: Day 35 ]
    in the afternoon after second supplement intake of every third day cycle

  35. Serum Hepcidin [ Time Frame: Day 38 ]
    in the afternoon after third supplement intake of every third day cycle

  36. Serum Hepcidin [ Time Frame: Day 52 ]
    in the afternoon 14 days after third supplement intake of every third day cycle



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Gender Eligibility Description:   Pregnancy
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • gestational week 14-16
  • singleton pregnancy
  • iron depleted, defined as serum ferritin SF <30 µg/L
  • non-anemic, defined as hemoglobin (Hb) >11g/dL

Exclusion Criteria:

  • acute or chronic disease
  • taking medications that could influence iron absorption
  • 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): NCT04074707


Contacts
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Contact: Hanna von Siebenthal +41 44 632 53 73 hanna.vonsiebenthal@hest.ethz.ch
Contact: Nicole Stoffel, PhD +41 44 632 83 93 nicole.stoffel@hest.ethz.ch

Locations
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Thailand
Mahidol University
Salaya, Nakhon Pathom, Thailand, 73170
Sponsors and Collaborators
Swiss Federal Institute of Technology
Mahidol University
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Responsible Party: Prof. Michael B. Zimmermann, Prof.Dr., Swiss Federal Institute of Technology
ClinicalTrials.gov Identifier: NCT04074707    
Other Study ID Numbers: TIPS
First Posted: August 30, 2019    Key Record Dates
Last Update Posted: August 30, 2019
Last Verified: August 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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, Iron-Deficiency
Anemia, Hypochromic
Anemia
Hematologic Diseases
Iron Metabolism Disorders
Metabolic Diseases