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PregnancyPROUDNCT07435766

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

A study testing MMS with 30 mg iron, MMS with 60 mg iron and IFA with 60 mg iron in people with Pregnancy, run by ETH Zurich at 2 sites in Kenya.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 35 years, women only
Conditions the study is for
Pregnancy
What is being tested?
MMS with 30 mg iron, MMS with 60 mg iron and IFA with 60 mg iron
Could I receive a placebo?
No, everyone receives an active treatment
How many people
50 participants
Where
2 sitesKenya
Study dates
2 Mar 2026to 31 Dec 2026
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 35 years
  • Women only
  • No healthy volunteers
  • Adult

Who may be able to join

  • 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
Show all 9Show fewer
  • 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

Who cannot join

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

Trial locations and contacts

2 sites in 1 country.

Kenya2 sites

  • Kwale Sub County Hospital

    Kwale, Kwale County

  • Msambweni County Referral Hospital

    Msambweni, Kwale County

Other trials in Kenya

About this study

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

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.

Conditions
Pregnancy
Being tested
MMS with 30 mg iron, MMS with 60 mg iron, IFA with 60 mg iron
Keywords
Iron Supplements, Dietary Supplements, Iron Deficiency, Pregnancy, Stable Iron Isotopes, Iron Absorption
Medical subject headings
Iron Deficiencies

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • MMS with 30 mg ironDietary supplement

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

  • MMS with 60 mg ironDietary supplement

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

  • IFA with 60 mg ironDietary supplement

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

Study groups in NCT07435766
Study groupRoleWhat they receive
Supplement crossover with maize porridge, comparison of iron absorptionExperimental1 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
Receives: Dietary Supplement: MMS with 30 mg iron; Dietary Supplement: MMS with 60 mg iron; Dietary Supplement: IFA with 60 mg iron
Supplement crossover with water, everyday vs. every other dayExperimentalThree 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
Receives: Dietary Supplement: MMS with 30 mg iron; Dietary Supplement: MMS with 60 mg iron; Dietary Supplement: IFA with 60 mg iron

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: 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.

    Measured: 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.

    Measured: 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.

    Measured: Day 70

Secondary outcomes (30)

  1. Hepcidin [µg/dL]

    Systemic iron regulator

    Measured: Day 19

  2. Hepcidin [µg/dL]

    Systemic iron regulator

    Measured: Day 20/21

  3. Hepcidin [µg/dL]

    Systemic iron regulator

    Measured: Day 22

  4. Hepcidin [µg/dL]

    Systemic iron regulator

    Measured: Day 36

  5. Hepcidin [µg/dL]

    Systemic iron regulator

    Measured: Day 37/38

  6. Hepcidin [µg/dL]

    Systemic iron regulator

    Measured: Day 39

  7. Hepcidin [µg/dL]

    Systemic iron regulator

    Measured: Day 53

  8. Hepcidin [µg/dL]

    Systemic iron regulator

    Measured: Day 54/55

  9. Hepcidin [µg/dL]

    Systemic iron regulator

    Measured: Day 56

  10. Hemoglobin (g/dL)

    Iron status marker

    Measured: Day 1

  11. Hemoglobin (g/dL)

    Iron status marker

    Measured: Day 19

  12. Hemoglobin (g/dL)

    Iron status marker

    Measured: Day 36

  13. Hemoglobin (g/dL)

    Iron status marker

    Measured: Day 53

  14. Hemoglobin (g/dL)

    Iron status marker

    Measured: Day 70

  15. Serum Ferritin (µg/L)

    Iron status marker

    Measured: Day 1

  16. Serum Ferritin (µg/L)

    Iron status marker

    Measured: Day 19

  17. Serum Ferritin (µg/L)

    Iron status marker

    Measured: Day 36

  18. Serum Ferritin (µg/L)

    Iron status marker

    Measured: Day 53

  19. C-reactive protein (mg/L)

    Chronic inflammation marker

    Measured: Day 1

  20. C-reactive protein (mg/L)

    Chronic inflammation marker

    Measured: Day 19

  21. C-reactive protein (mg/L)

    Chronic inflammation marker

    Measured: Day 36

  22. C-reactive protein (mg/L)

    Chronic inflammation marker

    Measured: Day 53

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

    Acute inflammation marker

    Measured: Day 1

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

    Acute inflammation marker

    Measured: Day 19

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

    Acute inflammation marker

    Measured: Day 36

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

    Acute inflammation marker

    Measured: Day 53

  27. soluble Transferrin Receptor (mg/L)

    Iron status marker

    Measured: Day 1

  28. soluble Transferrin Receptor (mg/L)

    Iron status marker

    Measured: Day 19

  29. soluble Transferrin Receptor (mg/L)

    Iron status marker

    Measured: Day 36

  30. soluble Transferrin Receptor (mg/L)

    Iron status marker

    Measured: Day 53

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted27 Feb 2026
  2. Study start2 Mar 2026
  3. Primary completionNov 2026 (estimated)
  4. Study completion31 Dec 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Other
Allocation
Randomised
Intervention model
Crossover
Masking
Single blind
Who is masked
Participant
Enrolment
50 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07435766
Sponsor's protocol ID
PROUD
Acronym
PROUD
Status last verified
Feb 2026
First submitted
20 Feb 2026
Last updated
5 Nov 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing MMS with 30 mg iron, MMS with 60 mg iron and IFA with 60 mg iron in people with Pregnancy, run by ETH Zurich at 2 sites in Kenya.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 5 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in Kenya. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Fractional iron absorption (%) (time frame: Day 19). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07435766.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Nov 2026.

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