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

• Sponsor: Swiss Federal Institute of Technology (Other)
• Overall Status: Unknown status
• CT.gov ID: NCT04074707
• Collaborator: Mahidol University (Other)
• Enrollment: 28
• Location: 1
• Arm: 1
• Anticipated Duration (Months): 3
• Patients Per Site Per Month: 9.4

Study Details

Study Description

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)	N/A

Study Design

• Study Type: Interventional
• Anticipated 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.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
• Anticipated Study Start Date: Sep 1, 2019
• Anticipated Primary Completion Date: Dec 1, 2019
• Anticipated Study Completion Date: Dec 1, 2019

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

1. Fractional iron absorption in % [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 % [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 % [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 % [Day 17]

   Fractional iron absorption measured from consecutive day cycle multiplied by the dose

5. Total iron absorption in % [Day 34]

   Fractional iron absorption measured from alternate day cycle multiplied by the dose

6. Total iron absorption in % [Day 52]

   Fractional iron absorption measured from every third day cycle multiplied by the dose

7. Serum Hepcidin [Day 0]

   in the morning a day before first supplement intake of consecutive day cycle

8. Serum Hepcidin [Day 1]

   in the morning before first supplement intake of consecutive day cycle

9. Serum Hepcidin [Day 2]

   in the morning before second supplement intake of consecutive day cycle

10. Serum Hepcidin [Day 3]

    in the morning before third supplement intake of consecutive day cycle

11. Serum Hepcidin [Day 17]

    in the morning before first supplement intake of alternate day cycle

12. Serum Hepcidin [Day 18]

    in the morning before second supplement intake of alternate day cycle

13. Serum Hepcidin [Day 20]

    in the morning before third supplement intake of alternate day cycle

14. Serum Hepcidin [Day 34]

    in the morning before first supplement intake of every third day cycle

15. Serum Hepcidin [Day 35]

    in the morning before second supplement intake of every third day cycle

16. Serum Hepcidin [Day 38]

    in the morning before third supplement intake of every third day cycle

17. Serum Hepcidin [Day 52]

    in the morning 14 days after last supplement intake of every third day cycle

Secondary Outcome Measures

1. Serum Ferritin (SF) [Day 0]

   in the morning 1 day before first supplement intake of consecutive day cycle

2. Serum Ferritin (SF) [Day 1]

   in the morning before first supplement intake of consecutive day cycle

3. Serum Ferritin (SF) [Day 17]

   in the morning before first supplement intake of alternate day cycle

4. Serum Ferritin (SF) [Day 34]

   in the morning before first supplement intake of every third day cycle

5. Serum Ferritin (SF) [Day 52]

   in the morning 14 days after last supplement intake of every third day

6. Hemoglobin (Hb) [Day 0]

   in the morning 1 day before first supplement intake of consecutive day cycle

7. Hemoglobin (Hb) [Day 1]

   in the morning before first supplement intake of consecutive day cycle

8. Hemoglobin (Hb) [Day 17]

   in the morning before first supplement intake of alternate day cycle

9. Hemoglobin (Hb) [Day 34]

   in the morning before first supplement intake of every third day cycle

10. Hemoglobin (Hb) [Day 52]

    in the morning 14 days after last supplement intake of every third day cycle

11. Soluble transferrin receptor (sTfR) [Day 0]

    in the morning 1 day before first supplement intake of consecutive day cycle

12. Soluble transferrin receptor (sTfR) [Day 1]

    in the morning before first supplement intake of consecutive day cycle

13. Soluble transferrin receptor (sTfR) [Day 17]

    in the morning before first supplement intake of alternate day cycle

14. Soluble transferrin receptor (sTfR) [Day 34]

    in the morning before first supplement intake of every third day cycle

15. Soluble transferrin receptor (sTfR) [Day 52]

    in the morning 14 days after last supplement intake of every third day cycle

16. C-reactive protein (CRP) [Day 0]

    in the morning 1 day before first supplement intake of consecutive day cycle

17. C-reactive protein (CRP) [Day 1]

    in the morning before first supplement intake of consecutive day cycle

18. C-reactive protein (CRP) [Day 17]

    in the morning before first supplement intake of alternate day cycle

19. C-reactive protein (CRP) [Day 34]

    in the morning before first supplement intake of every third day cycle

20. C-reactive protein (CRP) [Day 52]

    in the morning 14 days after last supplement intake of every third day cycle

21. Alpha-1-acid glycoprotein (AGP) [Day 0]

    in the morning 1 day before first supplement intake of consecutive day cycle

22. Alpha-1-acid glycoprotein (AGP) [Day 1]

    in the morning before first supplement intake of consecutive day cycle

23. Alpha-1-acid glycoprotein (AGP) [Day 17]

    in the morning before first supplement intake of alternate day cycle

24. Alpha-1-acid glycoprotein (AGP) [Day 34]

    in the morning before first supplement intake of every third day cycle

25. Alpha-1-acid glycoprotein (AGP) [Day 52]

    in the morning 14 days after last supplement intake of every third day cycle

26. Serum Hepcidin [Day 0]

    in the afternoon a day before first supplement intake of consecutive day cycle

27. Serum Hepcidin [Day 1]

    in the afternoon after first supplement intake of consecutive day cycle

28. Serum Hepcidin [Day 2]

    in the afternoon after second supplement intake of consecutive day cycle

29. Serum Hepcidin [Day 3]

    in the afternoon after third supplement intake of consecutive day cycle

30. Serum Hepcidin [Day 17]

    in the afternoon after first supplement intake of alternate day cycle

31. Serum Hepcidin [Day 18]

    in the afternoon after second supplement intake of alternate day cycle

32. Serum Hepcidin [Day 20]

    in the afternoon after third supplement intake of alternate day cycle

33. Serum Hepcidin [Day 34]

    in the afternoon after first supplement intake of every third day cycle

34. Serum Hepcidin [Day 35]

    in the afternoon after second supplement intake of every third day cycle

35. Serum Hepcidin [Day 38]

    in the afternoon after third supplement intake of every third day cycle

36. Serum Hepcidin [Day 52]

    in the afternoon 14 days after third supplement intake of every third day cycle

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 45 Years
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Mahidol University	Salaya	Nakhon Pathom	Thailand	73170

Sponsors and Collaborators

• Swiss Federal Institute of Technology
• Mahidol University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Prof. Michael B. Zimmermann, Prof.Dr., Swiss Federal Institute of Technology
• ClinicalTrials.gov Identifier: NCT04074707
• Other Study ID Numbers: TIPS
• First Posted: Aug 30, 2019
• Last Update Posted: Aug 30, 2019
• Last Verified: Aug 1, 2019

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Anemia, Iron-Deficiency

Study Results

No Results Posted as of Aug 30, 2019