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NCT Number: NCT07435766

Iron Absorption From IFA and MMS Supplements in Kenyan Women During the Second Trimester of Pregnancy

This study evaluates iron absorption from three antenatal supplements, 30 mg MMS, 60 mg MMS, and 60 mg IFA, in 50 pregnant Kenyan women in their second trimester. Using a randomized crossover design and stable iron isotopes, we will compare bioavailability in both fasted and fed states. Additionally, the trial will investigate if daily dosing triggers a hepcidin response that inhibits subsequent absorption, testing whether alternate-day dosing is a more effective strategy for treating iron deficiency.

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Key information

Conditions

Pregnancy Iron Deficiencies Iron Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year–35 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Kwale Sub County Hospital, Kwale, Kwale County, Kenya

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Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • female
  • pregnant at gestational age 12 (±1) weeks (dated by ultrasound)
  • age 18 to 35 y
  • Hb concentration ≥80 g/L
  • absence of significant inflammation
  • body weight <80 kg
  • no major chronic diseases
  • no intake of vitamin and mineral supplements outside of this study in the 1-2 weeks between screening and study start and during the study
  • no blood transfusion, blood donation, or significant blood loss over the past 4 months

Exclusion criteria

  • severe anemia (defined as Hb <80 g/L)
  • malaria
  • sickle cell disease (SS and SC)
  • hemoglobin C disease (CC).

Treatment and study plan

MMS with 30 mg iron

Dietary Supplement

Multiple Micronutrient Supplementation (MMS) with 30 mg of iron given with ferrous fumarate isotope (54Fe, 57Fe, 58Fe)

MMS with 60 mg iron

Dietary Supplement

Multiple Micronutrient Supplementation (MMS) with 60 mg of iron given with ferrous fumarate isotope (54Fe, 57Fe, 58Fe)

IFA with 60 mg iron

Dietary Supplement

Iron Folic Acid (IFA) with 60 mg of iron given with ferrous sulphate isotope (54Fe, 57Fe, 58Fe)

Primary outcomes

  1. Fractional iron absorption (%)

    Time frame: Day 19

    Fractional iron absorption calculated as the percentage of the administered labelled iron dose incorporated into red blood cells. The calculation is based on the measured shift in iron isotope ratios in blood samples collected 14 days after intake compared to baseline.

  2. Fractional iron absorption (%)

    Time frame: Day 36

    Fractional iron absorption calculated as the percentage of the administered labelled iron dose incorporated into red blood cells. The calculation is based on the measured shift in iron isotope ratios in blood samples collected 14 days after intake compared to baseline.

  3. Fractional iron absorption (%)

    Time frame: Day 53

    Fractional iron absorption calculated as the percentage of the administered labelled iron dose incorporated into red blood cells. The calculation is based on the measured shift in iron isotope ratios in blood samples collected 14 days after intake compared to baseline.

  4. Fractional iron absorption (%)

    Time frame: Day 70

    Fractional iron absorption calculated as the percentage of the administered labelled iron dose incorporated into red blood cells. The calculation is based on the measured shift in iron isotope ratios in blood samples collected 14 days after intake compared to baseline.

Secondary outcomes

  1. Hepcidin [µg/dL]

    Time frame: Day 19

    Systemic iron regulator

  2. Hepcidin [µg/dL]

    Time frame: Day 20/21

    Systemic iron regulator

  3. Hepcidin [µg/dL]

    Time frame: Day 22

    Systemic iron regulator

  4. Hepcidin [µg/dL]

    Time frame: Day 36

    Systemic iron regulator

  5. Hepcidin [µg/dL]

    Time frame: Day 37/38

    Systemic iron regulator

  6. Hepcidin [µg/dL]

    Time frame: Day 39

    Systemic iron regulator

  7. Hepcidin [µg/dL]

    Time frame: Day 53

    Systemic iron regulator

  8. Hepcidin [µg/dL]

    Time frame: Day 54/55

    Systemic iron regulator

  9. Hepcidin [µg/dL]

    Time frame: Day 56

    Systemic iron regulator

  10. Hemoglobin (g/dL)

    Time frame: Day 1

    Iron status marker

  11. Hemoglobin (g/dL)

    Time frame: Day 19

    Iron status marker

  12. Hemoglobin (g/dL)

    Time frame: Day 36

    Iron status marker

  13. Hemoglobin (g/dL)

    Time frame: Day 53

    Iron status marker

  14. Hemoglobin (g/dL)

    Time frame: Day 70

    Iron status marker

  15. Serum Ferritin (µg/L)

    Time frame: Day 1

    Iron status marker

  16. Serum Ferritin (µg/L)

    Time frame: Day 19

    Iron status marker

  17. Serum Ferritin (µg/L)

    Time frame: Day 36

    Iron status marker

  18. Serum Ferritin (µg/L)

    Time frame: Day 53

    Iron status marker

  19. C-reactive protein (mg/L)

    Time frame: Day 1

    Chronic inflammation marker

  20. C-reactive protein (mg/L)

    Time frame: Day 19

    Chronic inflammation marker

  21. C-reactive protein (mg/L)

    Time frame: Day 36

    Chronic inflammation marker

  22. C-reactive protein (mg/L)

    Time frame: Day 53

    Chronic inflammation marker

  23. Alpha-1-acid Glycoprotein (g/L)

    Time frame: Day 1

    Acute inflammation marker

  24. Alpha-1-acid Glycoprotein (g/L)

    Time frame: Day 19

    Acute inflammation marker

  25. Alpha-1-acid Glycoprotein (g/L)

    Time frame: Day 36

    Acute inflammation marker

  26. Alpha-1-acid Glycoprotein (g/L)

    Time frame: Day 53

    Acute inflammation marker

  27. soluble Transferrin Receptor (mg/L)

    Time frame: Day 1

    Iron status marker

  28. soluble Transferrin Receptor (mg/L)

    Time frame: Day 19

    Iron status marker

  29. soluble Transferrin Receptor (mg/L)

    Time frame: Day 36

    Iron status marker

  30. soluble Transferrin Receptor (mg/L)

    Time frame: Day 53

    Iron status marker

Study contacts

Contact information is provided by the study sponsor or research team.

Laura N Wasserfallen, MSc

CONTACT

[email protected]

+41 76 574 88 52

Sponsors and collaborators

Lead sponsor

ETH Zurich

Other

Registry information

Official study title

Comparing Iron Absorption From Multiple Micronutrient Supplements and Iron-folate Supplements: a Stable Isotope Study in Kenyan Pregnant Women

Acronym: PROUD

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Feb 27, 2026
Registry last updated
Feb 27, 2026

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.

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