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| Name | Class |
|---|---|
| Swiss Federal Institute of Technology | OTHER |
| Kamuzu University of Health Sciences | OTHER |
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The overall objective of this trial is to investigate the iron bioavailability from new infant cereals in Malawian infants.
In 30 infants aged 6 to 14 months old, the investigator will administer in random order over 2 phases separated by 14 days, 5 infant cereals containing either ferrous fumarate (4 meals) or ferrous bisglycinate (1 meal) intrinsically labeled with stable isotopes. The investigator will collect one blood sample at baseline and another sample at the end of each phase, thus 3 samples total. In these samples, fractional iron absorption and markers of iron and inflammation status will be measured . In addition, infant and child acceptability of one of the infant cereals will be assessed by using a questionnaire.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Testmeal A | Active Comparator | A new, whole-grain infant cereal fortified with ferrous fumarate |
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| Testmeal B | Active Comparator | An alternative new whole-grain infant cereal recipe fortified with ferrous fumarate |
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| Testmeal C | Placebo Comparator | An existing, refined grain infant cereal fortified with ferrous fumarate |
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| Testmeal D | Active Comparator | An existing, whole-grain infant cereal fortified with ferrous fumarate |
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| Testmeal E | Active Comparator | An existing, whole-grain infant cereal fortified with ferrous bisglycinate |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Labeled iron salt Fe54 | Other | Ferrous fumarate enriched with Fe 54 isotopes contains 2.25 mg of iron source and 13.5 mg of Vitamin C per serving |
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| Measure | Description | Time Frame |
|---|---|---|
| Fractional iron absorption of 54FeFum (test cereal A), 57FeFum (test cereal B), 54FeFum (test cereal C). | Fractional iron absorption of 54FeFum (test cereal A), 57FeFum (test cereal B), 54FeFum (test cereal C). Based on the shift of Fe isotope ratios in the blood samples and the amount of Fe circulating in the body, the amounts of 54Fe and 57Fe isotopic label present in the blood 14 days after the test meal administrations will be calculated on the principle of isotope dilution and considering that the iron isotopic labels are not mono-isotopic | up to 6 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Fractional iron absorption of 54FeFum (test cereal C), 57FeFum (test cereal D), 58FeBisGly (test cereal E). | Fractional iron absorption of 54FeFum (test cereal C), 57FeFum (test cereal D), 58FeBisGly (test cereal E). Based on the shift of Fe isotope ratios in the blood samples and the amount of Fe circulating in the body, the amounts of 54Fe, 57Fe and 58Fe isotopic label present in the blood 14 days after the test meal administrations will be calculated as described above for the primary endpoint |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Kamija Phiri, Prof. | Kamuzu University of Health Sciences | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Central Hospital | Zomba | Malawi |
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| Labeled iron salt Fe57 | Other | Ferrous fumarate enriched with Fe 57 isotopes contains 2.25 mg of iron source and 13.5 mg of Vitamin C per serving |
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| Labeled iron salt Fe58 | Other | Ferrous bisglycinate enriched with Fe 58 isotopes contains 2.25 mg of iron source and 13.5 mg of Vitamin C per serving |
|
| up to 6 weeks |
| Cereal acceptability questionnaire | up to 2 weeks |
| Fractional iron absorption from infants with (CRP ≥ 10 mg/L) or without (CRP < 10 mg/L) asymptomatic infection / inflammation. | up to 6 weeks |
| Standard reporting of adverse events (AEs) for safety assessment | Reported AEs will include type, incidence, severity, seriousness and relation to intervention. All concomitant medications used to treat illnesses and other conditions will be recorded (both dose and duration). | time of consent to 24 hours after final blood draw |