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

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.

Study Overview

• Status: Recruiting
• Conditions: Pregnancy
• Intervention / Treatment: Dietary supplement: MMS with 30 mg iron; Dietary supplement: MMS with 60 mg iron; Dietary supplement: IFA with 60 mg iron

• Study Type: Interventional
• Enrollment (Estimated): 50
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Laura N Wasserfallen, MSc; Phone Number: +41 76 574 88 52; Email: laura.wasserfallen@pharma.ethz.ch

Study Locations

• Kenya
  • Kwale County
    • Kwale, Kwale County, Kenya
      • Recruiting
      • Kwale Sub County Hospital
      • Contact: Suzane Nyilima, MSc; Phone Number: +254 702 836210; Email: suzane.nyilima@gmail.com
    • Msambweni, Kwale County, Kenya
      • Recruiting
      • Msambweni County Referral Hospital
      • Contact: Suzane Nyilima, MSc; Phone Number: +254 702 836210; Email: suzane.nyilima@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

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).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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; Multiple Micronutrient Supplementation (MMS) with 30 mg of iron given with ferrous fumarate isotope (54Fe, 57Fe, 58Fe); Dietary supplement: MMS with 60 mg iron; Multiple Micronutrient Supplementation (MMS) with 60 mg of iron given with ferrous fumarate isotope (54Fe, 57Fe, 58Fe); Dietary supplement: IFA with 60 mg iron; Iron Folic Acid (IFA) with 60 mg of iron given with ferrous sulphate isotope (54Fe, 57Fe, 58Fe)
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; Multiple Micronutrient Supplementation (MMS) with 30 mg of iron given with ferrous fumarate isotope (54Fe, 57Fe, 58Fe); Dietary supplement: MMS with 60 mg iron; Multiple Micronutrient Supplementation (MMS) with 60 mg of iron given with ferrous fumarate isotope (54Fe, 57Fe, 58Fe); Dietary supplement: IFA with 60 mg iron; Iron Folic Acid (IFA) with 60 mg of iron given with ferrous sulphate isotope (54Fe, 57Fe, 58Fe)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Hemoglobin (g/dL)	Iron status marker	Day 1
Serum Ferritin (µg/L)	Iron status marker	Day 1
soluble Transferrin Receptor (mg/L)	Iron status marker	Day 1
C-reactive protein (mg/L)	Chronic inflammation marker	Day 1
Alpha-1-acid Glycoprotein (g/L)	Acute inflammation marker	Day 1
Hepcidin [µg/dL]	Systemic iron regulator	Day 19
Hepcidin [µg/dL]	Systemic iron regulator	Day 20/21
Hepcidin [µg/dL]	Systemic iron regulator	Day 22
Hepcidin [µg/dL]	Systemic iron regulator	Day 36
Hepcidin [µg/dL]	Systemic iron regulator	Day 37/38
Hepcidin [µg/dL]	Systemic iron regulator	Day 39
Hepcidin [µg/dL]	Systemic iron regulator	Day 53
Hepcidin [µg/dL]	Systemic iron regulator	Day 54/55
Hepcidin [µg/dL]	Systemic iron regulator	Day 56
Hemoglobin (g/dL)	Iron status marker	Day 19
Hemoglobin (g/dL)	Iron status marker	Day 36
Hemoglobin (g/dL)	Iron status marker	Day 53
Hemoglobin (g/dL)	Iron status marker	Day 70
Serum Ferritin (µg/L)	Iron status marker	Day 19
Serum Ferritin (µg/L)	Iron status marker	Day 36
Serum Ferritin (µg/L)	Iron status marker	Day 53
C-reactive protein (mg/L)	Chronic inflammation marker	Day 19
C-reactive protein (mg/L)	Chronic inflammation marker	Day 36
C-reactive protein (mg/L)	Chronic inflammation marker	Day 53
Alpha-1-acid Glycoprotein (g/L)	Acute inflammation marker	Day 19
Alpha-1-acid Glycoprotein (g/L)	Acute inflammation marker	Day 36
Alpha-1-acid Glycoprotein (g/L)	Acute inflammation marker	Day 53
soluble Transferrin Receptor (mg/L)	Iron status marker	Day 19
soluble Transferrin Receptor (mg/L)	Iron status marker	Day 36
soluble Transferrin Receptor (mg/L)	Iron status marker	Day 53

Collaborators and Investigators

• Sponsor: ETH Zurich

Study record dates

Study Major Dates

• Study Start (Estimated): March 2, 2026
• Primary Completion (Estimated): July 31, 2026
• Study Completion (Estimated): December 31, 2026

Study Registration Dates

• First Submitted: February 20, 2026
• First Submitted That Met QC Criteria: February 20, 2026
• First Posted (Actual): February 27, 2026

Study Record Updates

• Last Update Posted (Actual): February 27, 2026
• Last Update Submitted That Met QC Criteria: February 20, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Keywords: Pregnancy; Dietary Supplements; Iron Deficiency; Iron Absorption; Iron Supplements; Stable Iron Isotopes
• Additional Relevant MeSH Terms: Metabolic Diseases; Iron Metabolism Disorders; Nutritional and Metabolic Diseases; Iron Deficiencies; Inorganic Chemicals; Elements; Metals; Metals, Heavy; Transition Elements; Iron
• Other Study ID Numbers: PROUD

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No