Clinical trial NCT03754543: Baby Iron Bioavailability Study
Official title: Iron Bioavailability From Fortified Cereal in Malawian Infants
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Iron Bioavailability
Lead sponsor: Société des Produits Nestlé (SPN)
Sponsor class: INDUSTRY
Collaborators: name: Swiss Federal Institute of Technology
name: Kamuzu University of Health Sciences
First posted: 2018-11-27
Enrollment: 30
Sex: ALL
Minimum age (years): 6
Maximum age (years): 14
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

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 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.

Eligibility criteria: Inclusion Criteria:

1. Infant age 6 - 14 months
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:

1. Parents not willing / not able to comply with the requirements of study protocol
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.

Primary outcomes:
measure: Fractional iron absorption of 54FeFum (test cereal A), 57FeFum (test cereal B), 54FeFum (test cereal C).
timeFrame: up to 6 weeks
Secondary outcomes:
measure: Fractional iron absorption of 54FeFum (test cereal C), 57FeFum (test cereal D), 58FeBisGly (test cereal E).
timeFrame: up to 6 weeks
measure: Cereal acceptability questionnaire
timeFrame: up to 2 weeks
measure: Fractional iron absorption from infants with (CRP ≥ 10 mg/L) or without (CRP < 10 mg/L) asymptomatic infection / inflammation.
timeFrame: up to 6 weeks
measure: Standard reporting of adverse events (AEs) for safety assessment
timeFrame: time of consent to 24 hours after final blood draw
Other outcomes:
Locations:
city: Zomba
country: Malawi
facility: Central Hospital
Study officials:
affiliation: Kamuzu University of Health Sciences
name: Kamija Phiri, Prof.
role: PRINCIPAL_INVESTIGATOR
References: