Baby Iron Bioavailability Study

Société des Produits Nestlé (SPN)30 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

BASIC_SCIENCE

Masking

SINGLE

Enrollment

Conditions

Iron Bioavailability

Interventions

Labeled iron salt Fe54OTHER

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 Fe57OTHER

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 Fe58OTHER

Ferrous bisglycinate enriched with Fe 58 isotopes contains 2.25 mg of iron source and 13.5 mg of Vitamin C per serving

Eligibility

Sex: ALLMin age: 6 MonthsMax age: 14 MonthsHealthy volunteers:

Medical Language ↔ Plain English

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.

Locations (1)

Central Hospital

Zomba, Malawi

Outcomes

Primary Outcomes

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

Time frame: up to 6 weeks

Secondary Outcomes

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

Time frame: up to 6 weeks

Cereal acceptability questionnaire

Time frame: up to 2 weeks

Fractional iron absorption from infants with (CRP ≥ 10 mg/L) or without (CRP < 10 mg/L) asymptomatic infection / inflammation.

Time frame: 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 frame: time of consent to 24 hours after final blood draw

Data from ClinicalTrials.gov

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