NCT07435766

Brief 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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at below P25 for not_applicable pregnancy

Timeline
8mo left

Started Mar 2026

Shorter than P25 for not_applicable pregnancy

Geographic Reach
1 country

2 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress15%
Mar 2026Dec 2026

First Submitted

Initial submission to the registry

February 20, 2026

Completed
7 days until next milestone

First Posted

Study publicly available on registry

February 27, 2026

Completed
3 days until next milestone

Study Start

First participant enrolled

March 2, 2026

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 31, 2026

Expected
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2026

Last Updated

February 27, 2026

Status Verified

February 1, 2026

Enrollment Period

5 months

First QC Date

February 20, 2026

Last Update Submit

February 20, 2026

Conditions

Pregnancy

Keywords

Iron SupplementsDietary SupplementsIron DeficiencyPregnancyStable Iron IsotopesIron Absorption

Outcome Measures

Primary Outcomes (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.

    Day 19

  • 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.

    Day 36

  • 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.

    Day 53

  • 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.

    Day 70

Secondary Outcomes (30)

  • Hepcidin [µg/dL]

    Day 19

  • Hepcidin [µg/dL]

    Day 20/21

  • Hepcidin [µg/dL]

    Day 22

  • Hepcidin [µg/dL]

    Day 36

  • Hepcidin [µg/dL]

    Day 37/38

  • +25 more secondary outcomes

Study Arms (2)

Supplement crossover with maize porridge, comparison of iron absorption

EXPERIMENTAL

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 ironDietary Supplement: MMS with 60 mg ironDietary Supplement: IFA with 60 mg iron

Supplement crossover with water, everyday vs. every other day

EXPERIMENTAL

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 ironDietary Supplement: MMS with 60 mg ironDietary Supplement: IFA with 60 mg iron

Interventions

MMS with 30 mg ironDIETARY_SUPPLEMENT

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

Supplement crossover with maize porridge, comparison of iron absorptionSupplement crossover with water, everyday vs. every other day
MMS with 60 mg ironDIETARY_SUPPLEMENT

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

Supplement crossover with maize porridge, comparison of iron absorptionSupplement crossover with water, everyday vs. every other day
IFA with 60 mg ironDIETARY_SUPPLEMENT

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

Supplement crossover with maize porridge, comparison of iron absorptionSupplement crossover with water, everyday vs. every other day

Eligibility Criteria

Age18 Years - 35 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Kwale Sub County Hospital

Kwale, Kwale County, Kenya

RECRUITING

Msambweni County Referral Hospital

Msambweni, Kwale County, Kenya

RECRUITING

MeSH Terms

Conditions

Iron Deficiencies

Interventions

Iron

Condition Hierarchy (Ancestors)

Iron Metabolism DisordersMetabolic DiseasesNutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Metals, HeavyElementsInorganic ChemicalsTransition ElementsMetals

Central Study Contacts

Laura N Wasserfallen, MSc

CONTACT

+41 76 574 88 52laura.wasserfallen@pharma.ethz.ch

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
OTHER
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Prof. Dr.

Study Record Dates

First Submitted

February 20, 2026

First Posted

February 27, 2026

Study Start

March 2, 2026

Primary Completion (Estimated)

July 31, 2026

Study Completion (Estimated)

December 31, 2026

Last Updated

February 27, 2026

Record last verified: 2026-02

Data Sharing

IPD Sharing
Will not share

Locations

KE(2)