Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
30 participants
INTERVENTIONAL
2019-01-31
2019-06-12
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
CROSSOVER
BASIC_SCIENCE
SINGLE
Study Groups
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Testmeal C
An existing, refined grain infant cereal fortified with ferrous fumarate
Labeled iron salt Fe54
Ferrous fumarate enriched with Fe 54 isotopes contains 2.25 mg of iron source and 13.5 mg of Vitamin C per serving
Testmeal D
An existing, whole-grain infant cereal fortified with ferrous fumarate
Labeled iron salt Fe57
Ferrous fumarate enriched with Fe 57 isotopes contains 2.25 mg of iron source and 13.5 mg of Vitamin C per serving
Testmeal E
An existing, whole-grain infant cereal fortified with ferrous bisglycinate
Labeled iron salt Fe58
Ferrous bisglycinate enriched with Fe 58 isotopes contains 2.25 mg of iron source and 13.5 mg of Vitamin C per serving
Testmeal A
A new, whole-grain infant cereal fortified with ferrous fumarate
Labeled iron salt Fe54
Ferrous fumarate enriched with Fe 54 isotopes contains 2.25 mg of iron source and 13.5 mg of Vitamin C per serving
Testmeal B
An alternative new whole-grain infant cereal recipe fortified with ferrous fumarate
Labeled iron salt Fe57
Ferrous fumarate enriched with Fe 57 isotopes contains 2.25 mg of iron source and 13.5 mg of Vitamin C per serving
Interventions
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Labeled iron salt Fe54
Ferrous fumarate enriched with Fe 54 isotopes contains 2.25 mg of iron source and 13.5 mg of Vitamin C per serving
Labeled iron salt Fe57
Ferrous fumarate enriched with Fe 57 isotopes contains 2.25 mg of iron source and 13.5 mg of Vitamin C per serving
Labeled iron salt Fe58
Ferrous bisglycinate enriched with Fe 58 isotopes contains 2.25 mg of iron source and 13.5 mg of Vitamin C per serving
Eligibility Criteria
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Inclusion Criteria
2. Infant exhibits no clinical signs / symptoms of chronic disease or acute illness
3. Capillary haemoglobin concentration \> 70g/L
4. Z-scores for weight-for-age and weight-for-length \> -2
5. Infant's parent(s) / legally acceptable representative is of legal age of consent, has anticipated residence in the area for the duration of the study, and is willing and able to fulfil the requirements of the study protocol
6. Infant is expected to consume the entire 25 g portion during infant cereal feeding based on the Investigator's judgement established via observations of feeding during the adaptation phase
7. Infant received a complete dose of intermittent preventive treatment with dihydroartemisinin piperaquine (IPTi-DP) as well a single dose of antihelminth treatment with Albendazole
Exclusion Criteria
2. Infants receiving iron-containing supplements in the 2 months prior to enrollment (other supplements are acceptable)
3. Infants with allergies or intolerance to wheat, oat, gluten or other ingredients in the test cereals (e.g., celiac disease)
4. Infants participating in any other clinical trial prior to enrollment
5. Infants or infant's family who in the Investigator's judgment cannot be expected to comply with the protocol or study procedures.
6 Months
14 Months
ALL
Yes
Sponsors
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Swiss Federal Institute of Technology
OTHER
Kamuzu University of Health Sciences
OTHER
Société des Produits Nestlé (SPN)
INDUSTRY
Responsible Party
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Principal Investigators
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Kamija Phiri, Prof.
Role: PRINCIPAL_INVESTIGATOR
Kamuzu University of Health Sciences
Locations
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Central Hospital
Zomba, , Malawi
Countries
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Other Identifiers
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18.05.INF
Identifier Type: -
Identifier Source: org_study_id
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