Status:
COMPLETED
Baby Iron Bioavailability Study
Lead Sponsor:
Société des Produits Nestlé (SPN)
Collaborating Sponsors:
Swiss Federal Institute of Technology
Kamuzu University of Health Sciences
Conditions:
Iron Bioavailability
Eligibility:
All Genders
6-14 years
Phase:
NA
Brief Summary
The overall objective of this trial is to investigate the iron bioavailability from new infant cereals in Malawian infants.
Detailed Description
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 bis...
Eligibility Criteria
Inclusion
- Infant age 6 - 14 months
- Infant exhibits no clinical signs / symptoms of chronic disease or acute illness
- Capillary haemoglobin concentration \> 70g/L
- Z-scores for weight-for-age and weight-for-length \> -2
- 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
- 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
- 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
- Parents not willing / not able to comply with the requirements of study protocol
- Infants receiving iron-containing supplements in the 2 months prior to enrollment (other supplements are acceptable)
- Infants with allergies or intolerance to wheat, oat, gluten or other ingredients in the test cereals (e.g., celiac disease)
- Infants participating in any other clinical trial prior to enrollment
- Infants or infant's family who in the Investigator's judgment cannot be expected to comply with the protocol or study procedures.
Key Trial Info
Start Date :
January 31 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 12 2019
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT03754543
Start Date
January 31 2019
End Date
June 12 2019
Last Update
July 16 2019
Active Locations (1)
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1
Central Hospital
Zomba, Malawi