CClinicalTrials.gg
RecruitingNCT07435766PROUDUpdated Feb 27, 2026

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

An interventional study of MMS with 30 mg iron and MMS with 60 mg iron in Pregnancy, sponsored by ETH Zurich. Recruiting at 2 sites in Kenya. Open to female participants aged 18 Years to 35 Years. Per ClinicalTrials.gov, last updated 2026-02-27.

Sponsored by ETH Zurich · Not applicable, Interventional, and Other

Phase
Not applicable
Study type
Interventional
Enrollment
50
Allocation
Randomized
Ages
18 Years to 35 Years
Sex
Female
01

Study summary

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.

02

Conditions studied

  • Pregnancy

Browse trials for

Keywords

  • Iron Supplements
  • Dietary Supplements
  • Iron Deficiency
  • Pregnancy
  • Stable Iron Isotopes
  • Iron Absorption
03

Who can participate

Ages eligible
18 Years to 35 Years
Sexes eligible
Female
Accepts healthy volunteers
No

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

Exclusion Criteria:

  • severe anemia (defined as Hb \<80 g/L)
  • malaria
  • sickle cell disease (SS and SC)
  • hemoglobin C disease (CC).
04

Study design

Phase
Not applicable
Primary purpose
Other
Allocation
Randomized
Intervention model
Crossover assignment
Masking
Single (Participant)
Enrollment
50 participants (estimated)

Study arms

  • Experimental
    Supplement crossover with maize porridge, comparison of iron absorption

    1 Block: Maize porridge with labelled ferrous fumarate or ferrous sulphate (54Fe, 57Fe or 58Fe) combined with either MMS with 30 mg of iron, MMS with 60 mg of iron, IFA with 60 mg of iron, given at day 1, day 3 and day 5

    Dietary Supplement: MMS with 30 mg iron · Dietary Supplement: MMS with 60 mg iron · Dietary Supplement: IFA with 60 mg iron

  • Experimental
    Supplement crossover with water, everyday vs. every other day

    Three blocks in randomized order: Block 1: Water with labelled ferrous fumarate (54Fe, 57Fe or 58Fe, randomized) combined with MMS with 30 mg of iron given at day 1, day 2/3 (randomized), day 4 Block 2: Water with labelled ferrous fumarate (54Fe, 57Fe or 58Fe, randomized) combined with MMS with 60 mg of iron given at day 1, day 2/3 (randomized), day 4 Block 3: Water with labelled ferrous sulphate (54Fe, 57Fe or 58Fe, randomized) combined with IFA with 60 mg of iron given at day 1, day 2/3 (randomized), day 4

    Dietary Supplement: MMS with 30 mg iron · Dietary Supplement: MMS with 60 mg iron · Dietary Supplement: IFA with 60 mg iron

Interventions

  • Dietary supplementMMS with 30 mg iron

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

  • Dietary supplementMMS with 60 mg iron

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

  • Dietary supplementIFA with 60 mg iron

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

05

What researchers measure

Primary outcomes

  1. Fractional iron absorption (%)

    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.

    Time frame: Day 19

  2. Fractional iron absorption (%)

    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.

    Time frame: Day 36

  3. Fractional iron absorption (%)

    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.

    Time frame: Day 53

  4. Fractional iron absorption (%)

    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.

    Time frame: Day 70

Secondary outcomes

  1. Hepcidin [µg/dL]

    Systemic iron regulator

    Time frame: Day 19

  2. Hepcidin [µg/dL]

    Systemic iron regulator

    Time frame: Day 20/21

  3. Hepcidin [µg/dL]

    Systemic iron regulator

    Time frame: Day 22

  4. Hepcidin [µg/dL]

    Systemic iron regulator

    Time frame: Day 36

  5. Hepcidin [µg/dL]

    Systemic iron regulator

    Time frame: Day 37/38

  6. Hepcidin [µg/dL]

    Systemic iron regulator

    Time frame: Day 39

  7. Hepcidin [µg/dL]

    Systemic iron regulator

    Time frame: Day 53

  8. Hepcidin [µg/dL]

    Systemic iron regulator

    Time frame: Day 54/55

  9. Hepcidin [µg/dL]

    Systemic iron regulator

    Time frame: Day 56

  10. Hemoglobin (g/dL)

    Iron status marker

    Time frame: Day 1

  11. Hemoglobin (g/dL)

    Iron status marker

    Time frame: Day 19

  12. Hemoglobin (g/dL)

    Iron status marker

    Time frame: Day 36

  13. Hemoglobin (g/dL)

    Iron status marker

    Time frame: Day 53

  14. Hemoglobin (g/dL)

    Iron status marker

    Time frame: Day 70

  15. Serum Ferritin (µg/L)

    Iron status marker

    Time frame: Day 1

  16. Serum Ferritin (µg/L)

    Iron status marker

    Time frame: Day 19

  17. Serum Ferritin (µg/L)

    Iron status marker

    Time frame: Day 36

  18. Serum Ferritin (µg/L)

    Iron status marker

    Time frame: Day 53

  19. C-reactive protein (mg/L)

    Chronic inflammation marker

    Time frame: Day 1

  20. C-reactive protein (mg/L)

    Chronic inflammation marker

    Time frame: Day 19

  21. C-reactive protein (mg/L)

    Chronic inflammation marker

    Time frame: Day 36

  22. C-reactive protein (mg/L)

    Chronic inflammation marker

    Time frame: Day 53

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

    Acute inflammation marker

    Time frame: Day 1

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

    Acute inflammation marker

    Time frame: Day 19

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

    Acute inflammation marker

    Time frame: Day 36

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

    Acute inflammation marker

    Time frame: Day 53

  27. soluble Transferrin Receptor (mg/L)

    Iron status marker

    Time frame: Day 1

  28. soluble Transferrin Receptor (mg/L)

    Iron status marker

    Time frame: Day 19

  29. soluble Transferrin Receptor (mg/L)

    Iron status marker

    Time frame: Day 36

  30. soluble Transferrin Receptor (mg/L)

    Iron status marker

    Time frame: Day 53

06

Study locations

2 of 2 sites recruiting
  • Kwale Sub County Hospital
    Kwale, Kwale County, Kenya
    Recruiting
  • Msambweni County Referral Hospital
    Msambweni, Kwale County, Kenya
    Recruiting
07

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

08

Registry details

Key details

Study ID
NCT07435766
Lead sponsor
ETH Zurich
Responsible party
Nicole Stoffel (Prof. Dr., ETH Zurich) — Principal investigator
First posted
Feb 27, 2026
Start date
Mar 2, 2026 (estimated)
Primary completion
Jul 31, 2026 (estimated)
Completion
Dec 31, 2026 (estimated)
Last update
Feb 27, 2026

Study contacts

Laura N Wasserfallen, MSc
Contact
laura.wasserfallen@pharma.ethz.ch
+41 76 574 88 52

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Interested in this study?

Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.

Contact study team

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion