Baby Iron Bioavailability Study

Iron Bioavailability From Fortified Cereal in Malawian Infants

The overall objective of this trial is to investigate the iron bioavailability from new infant cereals in Malawian infants.

Study Overview

• Status: Completed
• Conditions: Iron Bioavailability
• Intervention / Treatment: Other: Labeled iron salt Fe54; Other: Labeled iron salt Fe57; Other: Labeled iron salt Fe58

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 Type: Interventional
• Enrollment (Actual): 30
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Malawi
  • Zomba, Malawi
    • Central Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 6 months to 1 year (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Single

Number of Arms

5

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Testmeal A; A new, whole-grain infant cereal fortified with ferrous fumarate	Other: 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
Active Comparator: Testmeal B; An alternative new whole-grain infant cereal recipe fortified with ferrous fumarate	Other: 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
Placebo Comparator: Testmeal C; An existing, refined grain infant cereal fortified with ferrous fumarate	Other: 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
Active Comparator: Testmeal D; An existing, whole-grain infant cereal fortified with ferrous fumarate	Other: 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
Active Comparator: Testmeal E; An existing, whole-grain infant cereal fortified with ferrous bisglycinate	Other: 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	up to 6 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	up to 6 weeks
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	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 of consent to 24 hours after final blood draw

Collaborators and Investigators

• Sponsor: Nestlé
• Collaborators: Swiss Federal Institute of Technology; Kamuzu University of Health Sciences
• Investigators: Principal Investigator: Kamija Phiri, Prof., Kamuzu University of Health Sciences

Study record dates

Study Major Dates

• Study Start (Actual): January 31, 2019
• Primary Completion (Actual): June 12, 2019
• Study Completion (Actual): June 12, 2019

Study Registration Dates

• First Submitted: October 4, 2018
• First Submitted That Met QC Criteria: November 22, 2018
• First Posted (Actual): November 27, 2018

Study Record Updates

• Last Update Posted (Actual): July 16, 2019
• Last Update Submitted That Met QC Criteria: July 15, 2019
• Last Verified: July 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Trace Elements; Micronutrients; Iron
• Other Study ID Numbers: 18.05.INF

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No