Pregnancy
Conditions
Keywords
Iron Supplements, Dietary Supplements, Iron Deficiency, Pregnancy, Stable Iron Isotopes, Iron Absorption
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.
Interventions
DIETARY_SUPPLEMENTMMS with 30 mg iron
Multiple Micronutrient Supplementation (MMS) with 30 mg of iron given with ferrous fumarate isotope (54Fe, 57Fe, 58Fe)
DIETARY_SUPPLEMENTMMS with 60 mg iron
Multiple Micronutrient Supplementation (MMS) with 60 mg of iron given with ferrous fumarate isotope (54Fe, 57Fe, 58Fe)
DIETARY_SUPPLEMENTIFA with 60 mg iron
Iron Folic Acid (IFA) with 60 mg of iron given with ferrous sulphate isotope (54Fe, 57Fe, 58Fe)
Sponsors
ETH Zurich
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
OTHER
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 35 Years
Healthy volunteers
No
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).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Fractional iron absorption (%) | Day 19 | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Hepcidin [µg/dL] | Day 19 | Systemic iron regulator |
| Hemoglobin (g/dL) | Day 1 | Iron status marker |
| Serum Ferritin (µg/L) | Day 1 | Iron status marker |
| C-reactive protein (mg/L) | Day 1 | Chronic inflammation marker |
| Alpha-1-acid Glycoprotein (g/L) | Day 1 | Acute inflammation marker |
| soluble Transferrin Receptor (mg/L) | Day 1 | Iron status marker |
Countries
Kenya
Contacts
CONTACTLaura N Wasserfallen, MSc
Outcome results
None listed