Baby Iron Bioavailability Study

Not Applicable

Completed

• Conditions: Iron Bioavailability
• Interventions: Other: Labeled iron salt Fe54; Other: Labeled iron salt Fe57; Other: Labeled iron salt Fe58

• Registration Number: NCT03754543
• Lead Sponsor: Société des Produits Nestlé (SPN)

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.

Study Timeline

• Study First Submitted: 2018-10-04
• Study First Submitted QC: 2018-11-22
• Study First Posted: 2018-11-27
• Study Start: 2019-01-31
• Primary Completion: 2019-06-12
• Study Completion: 2019-06-12
• Status Verified: 2019-07
• Last Update Submitted: 2019-07-15
• Last Update Posted: 2019-07-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Testmeal A	Labeled iron salt Fe54	A new, whole-grain infant cereal fortified with ferrous fumarate
Testmeal B	Labeled iron salt Fe57	An alternative new whole-grain infant cereal recipe fortified with ferrous fumarate
Testmeal C	Labeled iron salt Fe54	An existing, refined grain infant cereal fortified with ferrous fumarate
Testmeal D	Labeled iron salt Fe57	An existing, whole-grain infant cereal fortified with ferrous fumarate
Testmeal E	Labeled iron salt Fe58	An existing, whole-grain infant cereal fortified with ferrous bisglycinate

Primary Outcome Measures

Name	Time	Method
Fractional iron absorption of 54FeFum (test cereal A), 57FeFum (test cereal B), 54FeFum (test cereal C).	up to 6 weeks	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

Secondary Outcome Measures

Name	Time	Method
Fractional iron absorption of 54FeFum (test cereal C), 57FeFum (test cereal D), 58FeBisGly (test cereal E).	up to 6 weeks	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
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	time of consent to 24 hours after final blood draw	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).

Trial Locations

Locations (1)

Central Hospital; 🇲🇼 Zomba, Malawi