Skip to main content
OpenTrials
Completed

NCT Number: NCT04074707

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Iron Deficiency Anemia of Pregnancy

Age range

18 year–45 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Mahidol University

Salaya, Changwat Nakhon Pathom, 73170, Thailand

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • gestational week 14-16 at study start
  • singleton pregnancy
  • Serum ferritin SF <60 µg/L
  • non-anemic or mildly anemic, defined as hemoglobin (Hb) >10 g/dL
  • female aged 18-45 years
  • healthy Thai woman

Exclusion criteria

  • acute or chronic disease
  • taking medications that could influence iron absorption
  • smoking

Treatment and study plan

Labeled iron solution (60mg and 120mg Ferrous Fumarate)

Dietary Supplement

3 doses of 60mg iron as ferrous fumarate are given on one consecutive day and one alternate day (e.g., days 1, 2, 4); 3 doses of 120mg iron as ferrous fumarate are given on one consecutive and one alternate day (e.g., days 20, 21, 23); 3 doses of 120mg iron as ferrous fumarate 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 200ml deionized water (57Fe, 58Fe or 54Fe). Participants will be randomly assigned to start with 60mg iron daily vs alternate day dosing, 120mg daily vs alternate day dosing or 120mg daily vs every-third day dosing.

Primary outcomes

  1. Fractional iron absorption in %

    Time frame: Day 18

    Erythrocyte incorporation of stable iron isotopes 14 days after the last supplement intake of the 60mg daily vs alternate day cycle

  2. Fractional iron absorption in %

    Time frame: Day 35

    Erythrocyte incorporation of stable iron isotopes 14 days after the last supplement intake of the 120mg daily vs alternate day cycle

  3. Fractional iron absorption in %

    Time frame: Day 53

    Erythrocyte incorporation of stable iron isotopes 14 days after the last supplement intake of the 120mg daily vs every third day cycle

  4. Total iron absorption in %

    Time frame: Day 18

    Fractional iron absorption measured from the 60mg daily vs alternate day cycle multiplied by the dose

  5. Total iron absorption in %

    Time frame: Day 35

    Fractional iron absorption measured from the 120mg daily vs alternate day cycle multiplied by the dose

  6. Total iron absorption in %

    Time frame: Day 53

    Fractional iron absorption measured from the 120mg daily vs every third day cycle multiplied by the dose

  7. Serum Hepcidin

    Time frame: Day 1

    in the morning before first supplement intake of the 60mg daily vs alternate day cycle

  8. Serum Hepcidin

    Time frame: Day 2

    in the morning before second supplement intake of the 60mg daily vs alternate day cycle

  9. Serum Hepcidin

    Time frame: Day 4

    in the morning before third supplement intake of the 60mg daily vs alternate day cycle

  10. Serum Hepcidin

    Time frame: Day 18

    in the morning before first supplement intake of 120mg daily vs alternate day cycle

  11. Serum Hepcidin

    Time frame: Day 19

    in the morning before second supplement intake of 120mg daily vs alternate day cycle

  12. Serum Hepcidin

    Time frame: Day 21

    in the morning before third supplement intake of 120mg daily vs alternate day cycle

  13. Serum Hepcidin

    Time frame: Day 35

    in the morning before first supplement intake of the 120mg daily vs every third day cycle

  14. Serum Hepcidin

    Time frame: Day 36

    in the morning before second supplement intake of the 120mg daily vs every third day cycle

  15. Serum Hepcidin

    Time frame: Day 39

    in the morning before third supplement intake of the 120mg daily vs every third day cycle

  16. Serum Hepcidin

    Time frame: Day 53

    in the morning 14 days after last supplement intake the 120mg daily vs every third day cycle

Secondary outcomes

  1. Serum Ferritin (SF)

    Time frame: Screening

    in the morning before first supplement intake

  2. Serum Ferritin (SF)

    Time frame: Day 1

    in the morning before first supplement intake of the 60mg daily vs alternate day cycle

  3. Serum Ferritin (SF)

    Time frame: Day 18

    in the morning before first supplement intake of the 120mg daily vs alternate day cycle

  4. Serum Ferritin (SF)

    Time frame: Day 35

    in the morning before first supplement intake of the 120mg daily vs every third day cycle

  5. Serum Ferritin (SF)

    Time frame: Day 53

    in the morning 14 days after last supplement intake of the 120mg daily vs every third day cycle

  6. Hemoglobin (Hb)

    Time frame: Screening

    in the morning before first supplement intake

  7. Hemoglobin (Hb)

    Time frame: Day 1

    in the morning before first supplement intake of the 60mg daily vs alternate day cycle

  8. Hemoglobin (Hb)

    Time frame: Day 18

    in the morning before first supplement intake of the 120mg daily vs alternate day cycle

  9. Hemoglobin (Hb)

    Time frame: Day 35

    in the morning before first supplement intake of the 120mg daily vs every third day cycle

  10. Hemoglobin (Hb)

    Time frame: Day 53

    in the morning 14 days after last supplement intake of the 120mg daily vs every third day cycle

  11. Soluble transferrin receptor (sTfR)

    Time frame: Day 1

    in the morning before first supplement intake of the 60mg daily vs alternate day cycle

  12. Soluble transferrin receptor (sTfR)

    Time frame: Day 18

    in the morning before first supplement intake of the 120mg daily vs alternate day cycle

  13. Soluble transferrin receptor (sTfR)

    Time frame: Day 35

    in the morning before first supplement intake of the 120mg daily vs every third day cycle

  14. Soluble transferrin receptor (sTfR)

    Time frame: Day 53

    in the morning 14 days after last supplement intake of the 120mg daily vs every third day cycle

  15. C-reactive protein (CRP)

    Time frame: Day 1

    in the morning before first supplement intake of the 60mg daily vs alternate day cycle

  16. C-reactive protein (CRP)

    Time frame: Day 18

    in the morning before first supplement intake of the 120mg daily vs alternate day cycle

  17. C-reactive protein (CRP)

    Time frame: Day 35

    in the morning before first supplement intake of the 120mg daily vs every third day cycle

  18. C-reactive protein (CRP)

    Time frame: Day 53

    in the morning 14 days after last supplement intake of the 120mg daily vs every third day cycle

  19. Alpha-1-acid glycoprotein (AGP)

    Time frame: Day 1

    in the morning before first supplement intake of the 60mg daily vs alternate day cycle

  20. Alpha-1-acid glycoprotein (AGP)

    Time frame: Day 18

    in the morning before first supplement intake of the 120mg daily vs alternate day cycle

  21. Alpha-1-acid glycoprotein (AGP)

    Time frame: Day 35

    in the morning before first supplement intake of the 120mg daily vs every third day cycle

  22. Alpha-1-acid glycoprotein (AGP)

    Time frame: Day 53

    in the morning 14 days after last supplement intake of the 120mg daily vs every third day cycle

  23. Serum Hepcidin

    Time frame: Day 1

    in the afternoon after first supplement intake of the 60mg daily vs alternate day cycle

  24. Serum Hepcidin

    Time frame: Day 18

    in the afternoon after first supplement intake of the 120mg daily vs alternate day cycle

  25. Serum Hepcidin

    Time frame: Day 53

    in the afternoon 14 days after third supplement intake of the 120mg daily vs every third day cycle

  26. Serum Iron (SFe)

    Time frame: Day 1

    in the morning before first supplement intake of the 60mg daily vs alternate day cycle

  27. Serum Iron (SFe)

    Time frame: Day 2

    in the morning before second supplement intake of the 60mg daily vs alternate day cycle

  28. Serum Iron (SFe)

    Time frame: Day 4

    in the morning before third supplement intake of the 60mg daily vs alternate day cycle

  29. Serum Iron (SFe)

    Time frame: Day 1

    in the afternoon after first supplement intake of the 60mg daily vs alternate day cycle

  30. Serum Iron (SFe)

    Time frame: Day 18

    in the morning before the first supplement intake of the 120mg daily vs alternate day cycle

  31. Serum Iron (SFe)

    Time frame: Day 19

    in the morning before the second supplement intake of the 120mg daily vs alternate day cycle

  32. Serum Iron (SFe)

    Time frame: Day 21

    in the morning before the third supplement intake of the 120mg daily vs alternate day cycle

  33. Serum Iron (SFe)

    Time frame: Day 18

    in the afternoon after the first supplement intake of the 120mg daily vs alternate day cycle

  34. Serum Iron (SFe)

    Time frame: Day 35

    in the morning before the first supplement intake of the 120mg daily vs every third day cycle

  35. Serum Iron (SFe)

    Time frame: Day 36

    in the morning before the second supplement intake of the 120mg daily vs every third day cycle

  36. Serum Iron (SFe)

    Time frame: Day 39

    in the morning before the third supplement intake of the 120mg daily vs every third day cycle

  37. Serum Iron (SFe)

    Time frame: Day 53

    in the morning 14 days after the last supplement intake of the 120mg daily vs every third day cycle

  38. Serum Iron (SFe)

    Time frame: Day 53

    in the afternoon 14 days after the last supplement intake of the 120mg daily vs every third day cycle

  39. Total Iron Binding Capacity (TIBC)

    Time frame: Day 1

    in the morning before first supplement intake of the 60mg daily vs alternate day cycle

  40. Total Iron Binding Capacity (TIBC)

    Time frame: Day 2

    in the morning before second supplement intake of the 60mg daily vs alternate day cycle

  41. Total Iron Binding Capacity (TIBC)

    Time frame: Day 4

    in the morning before third supplement intake of the 60mg daily vs alternate day cycle

  42. Total Iron Binding Capacity (TIBC)

    Time frame: Day 1

    in the afternoon after first supplement intake of the 60mg daily vs alternate day cycle

  43. Total Iron Binding Capacity (TIBC)

    Time frame: Day 18

    in the morning before first supplement intake of the 120mg daily vs alternate day cycle

  44. Total Iron Binding Capacity (TIBC)

    Time frame: Day 19

    in the morning before second supplement intake of the 120mg daily vs alternate day cycle

  45. Total Iron Binding Capacity (TIBC)

    Time frame: Day 21

    in the morning before third supplement intake of the 120mg daily vs alternate day cycle

  46. Total Iron Binding Capacity (TIBC)

    Time frame: Day 18

    in the afternoon after first supplement intake of the 120mg daily vs alternate day cycle

  47. Total Iron Binding Capacity (TIBC)

    Time frame: Day 35

    in the morning before first supplement intake of the 120mg daily vs every third day cycle

  48. Total Iron Binding Capacity (TIBC)

    Time frame: Day 36

    in the morning before second supplement intake of the 120mg daily vs every third day cycle

  49. Total Iron Binding Capacity (TIBC)

    Time frame: Day 39

    in the morning before third supplement intake of the 120mg daily vs every third day cycle

  50. Total Iron Binding Capacity (TIBC)

    Time frame: Day 53

    in the morning 14 after last supplement intake of the 120mg daily vs every third day cycle

  51. Total Iron Binding Capacity (TIBC)

    Time frame: Day 53

    in the afternoon 14 after last supplement intake of the 120mg daily vs every third day cycle

Sponsors and collaborators

Lead sponsor

Swiss Federal Institute of Technology

Other

Collaborators

  • Mahidol University

Registry information

Official study 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

Important dates

Study start
2019
Primary completion
2022
Study completion
2022
First posted
Aug 30, 2019
Registry last updated
Jul 24, 2024

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.

Related clinical trials

Published trials that share one or more normalized conditions with this study.