Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
|
| 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| MMS with 30 mg iron | Dietary Supplement | Multiple Micronutrient Supplementation (MMS) with 30 mg of iron given with ferrous fumarate isotope (54Fe, 57Fe, 58Fe) |
|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Hepcidin [µg/dL] | Systemic iron regulator | Day 19 |
| Hepcidin [µg/dL] | Systemic iron regulator | Day 20/21 |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Laura N Wasserfallen, MSc | Contact | +41 76 574 88 52 | laura.wasserfallen@pharma.ethz.ch |
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Kwale Sub County Hospital | Recruiting | Kwale | Kwale County | Kenya |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D000090463 | Iron Deficiencies |
| ID | Term |
|---|---|
| D019189 | Iron Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D007501 | Iron |
| ID | Term |
|---|---|
| D019216 | Metals, Heavy |
| D004602 | Elements |
| D007287 | Inorganic Chemicals |
| D028561 | Transition Elements |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| MMS with 60 mg iron | Dietary Supplement | Multiple Micronutrient Supplementation (MMS) with 60 mg of iron given with ferrous fumarate isotope (54Fe, 57Fe, 58Fe) |
|
| IFA with 60 mg iron | Dietary Supplement | Iron Folic Acid (IFA) with 60 mg of iron given with ferrous sulphate isotope (54Fe, 57Fe, 58Fe) |
|
| 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 1 |
| 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 1 |
| 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 1 |
| 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 1 |
| 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 1 |
| 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 |
| Msambweni County Referral Hospital | Recruiting | Msambweni | Kwale County | Kenya |
|
| D008670 |
| Metals |