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

NCT04074707 | Completed

• 1 other identifier: TIPS
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Iron Deficiency Anemia of Pregnancy

Outcome Measures

Primary Outcomes (16)

• Fractional iron absorption in %

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

  Day 18

• Fractional iron absorption in %

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

  Day 35

• Fractional iron absorption in %

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

  Day 53

• Total iron absorption in %

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

  Day 18

• Total iron absorption in %

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

  Day 35

• Total iron absorption in %

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

  Day 53

• Serum Hepcidin

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

  Day 1

• Serum Hepcidin

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

  Day 2

• Serum Hepcidin

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

  Day 4

• Serum Hepcidin

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

  Day 18

• Serum Hepcidin

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

  Day 19

• Serum Hepcidin

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

  Day 21

• Serum Hepcidin

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

  Day 35

• Serum Hepcidin

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

  Day 36

• Serum Hepcidin

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

  Day 39

• Serum Hepcidin

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

  Day 53

Secondary Outcomes (51)

• Serum Ferritin (SF)

  Screening

• Serum Ferritin (SF)

  Day 1

• Serum Ferritin (SF)

  Day 18

• Serum Ferritin (SF)

  Day 35

• Serum Ferritin (SF)

  Day 53

Study Arms (1)

oral iron supplementation

EXPERIMENTAL

Participants go through 3 cycles of oral iron Supplementation (60mg daily vs alternate day dosing, 120mg daily vs alternate day dosing, 120mg daily vs every third-day dosing)

Dietary Supplement: Labeled iron solution (60mg and 120mg Ferrous Fumarate)

Interventions

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.

oral iron supplementation

Eligibility Criteria

• Age: 18 Years - 45 Years
• Gender Eligibility Details: Pregnancy
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Swiss Federal Institute of Technology: lead
• Mahidol University: collaborator

Study Sites (1)

Mahidol University

Salaya, Changwat Nakhon Pathom, 73170, Thailand

Location

Related Publications (1)

• von Siebenthal HK, Moretti D, Zimmermann MB, Stoffel NU. Effect of dietary factors and time of day on iron absorption from oral iron supplements in iron deficient women. Am J Hematol. 2023 Sep;98(9):1356-1363. doi: 10.1002/ajh.26987. Epub 2023 Jun 26.

  PMID: 37357807 DERIVED

MeSH Terms

Interventions

ferrous fumarate

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof.Dr.

Model Details: each subject acts as her own control by going through all the three supplementation cycles. Women will be randomly assigned to start with the 60mg daily vs alternate day, 120mg daily vs alternate day or 120mg daily vs every third day supplementation cycle.

Study Record Dates

• First Submitted: August 27, 2019
• First Posted: August 30, 2019
• Study Start: October 24, 2019
• Primary Completion: June 30, 2022
• Study Completion: June 30, 2022
• Last Updated: July 24, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share

Locations

TH (1)