NCT07435766 - Iron Absorption From IFA and MMS Supplements in Kenyan Women During the Second Trimester of Pregnancy | Crick

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

OTHER

Masking

SINGLE

Enrollment

50

Conditions

Pregnancy

Interventions

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)

Eligibility

Sex: FEMALEMin age: 18 YearsMax age: 35 Years

Medical Language ↔ Plain English

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).

Locations (2)

Kwale Sub County Hospital

Kwale, Kwale County, Kenya

RECRUITING

Msambweni County Referral Hospital

Msambweni, Kwale County, Kenya

RECRUITING

Outcomes

Primary Outcomes

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

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

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

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

Hepcidin [µg/dL]

Systemic iron regulator

Time frame: Day 19

Hepcidin [µg/dL]

Systemic iron regulator

Time frame: Day 20/21

Hepcidin [µg/dL]

Central Contacts

Laura N Wasserfallen, MSc

CONTACT

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