ClinicalTrials.gg
Sign In
Active, not recruitingNCT07435766PROUDUpdated Nov 5, 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. Active, not recruiting at 2 sites in Kenya. Open to female participants aged 18 Years to 35 Years. Per ClinicalTrials.gov, last updated 2026-11-05.

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

Updated Nov 5, 2026Now Active, not recruitingPrimary completion movedGo to Updates ↓
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

In context

Iron Deficiencies

386 studies on the registry are indexed under Iron Deficiencies; 80 are open to participants now.

This study's planned enrollment of 50 is below the median of 99 across 301 interventional studies indexed under Iron Deficiencies.

Browse Iron Deficiencies studies →

Lead sponsor

ETH Zurich is the lead sponsor of 20 studies on the registry; 12 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

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

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • female
  • pregnant at gestational age 12 (±1) weeks (dated by ultrasound)
  • age 18 to 35 y
  • 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 \<80 g/L)
  • malaria
  • sickle cell disease (SS and SC)
  • hemoglobin C disease (CC).
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Hemoglobin (Hb)

The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).

05

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

    Drug pages: Methyl Methanesulfonate · Iron

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

  • Dietary supplementMMS with 60 mg iron

    Drug pages: Methyl Methanesulfonate · Iron

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

  • Dietary supplementIFA with 60 mg iron

    Drug pages: Incomplete Freund's adjuvant · Iron

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

06

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

07

Study locations

2 sites
  • Kwale Sub County Hospital
    Kwale, Kwale County, Kenya
  • Msambweni County Referral Hospital
    Msambweni, Kwale County, Kenya
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

1 registry update since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedDate before it movedWhere the date was before it movedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Mar 2026 (actual). Primary completion is estimated for Nov 2026, 8 months after the start.

Of 76 non-industry interventional studies with no phase under Iron Deficiencies, half reached primary completion within 9 months of starting (the median), counting those still running; a quarter within 4 and three quarters within 26. This study's planned 8 months is below that.

Counting every sponsor, half of 88 studies reached it within 10 months; a quarter within 5 and three quarters within 26.

Primary completion moved once since we started tracking on Sep 25, 2026: Jul 2026 → Nov 2026, on Nov 5, 2026.

Earlier changes are on the record history on ClinicalTrials.gov ↗

How these figures are worked out, and which studies are left out of them.

Registered
Feb 20, 2026
First posted
Feb 27, 2026
StartActual
Mar 2, 2026
Primary completionEst.
Nov 2026was Jul 2026
CompletionEst.
Dec 31, 2026
Last update
Nov 5, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
Status
Recruiting→Active, not recruiting
changed Nov 5, 2026
Primary completion
Jul 31, 2026→Nov 2026
Nov 5, 2026
Show all 1 update
  1. Nov 5, 2026
    Recruiting→Active, not recruiting
    Primary completion Jul 31, 2026→Nov 2026
    + 2 other changes: contact details and site details

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

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
Primary completion
Nov 2026 (estimated)
Completion
Dec 31, 2026 (estimated)
Last update
Nov 5, 2026

Oversight

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

Not currently enrolling

This study is active, not recruiting, as verified in Feb 2026. You cannot join it, but the record below documents what was studied.

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.

Studies of the drugs tested here: Methyl Methanesulfonate · Iron · Incomplete Freund's adjuvant

Other studies in this condition

Iron Deficiencies →

Other studies from this sponsor

ETH Zurich

Start the discussion