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Completed

NCT Number: NCT03754543

Baby Iron Bioavailability Study

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

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Key information

Age range

6 month–14 month

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Central Hospital

Zomba, Malawi

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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 criteria

  • 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.

Treatment and study plan

Labeled iron salt Fe54

Other

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 Fe57

Other

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 Fe58

Other

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

Primary outcomes

  1. Fractional iron absorption of 54FeFum (test cereal A), 57FeFum (test cereal B), 54FeFum (test cereal C).

    Time frame: 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 outcomes

  1. Fractional iron absorption of 54FeFum (test cereal C), 57FeFum (test cereal D), 58FeBisGly (test cereal E).

    Time frame: 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

  2. Cereal acceptability questionnaire

    Time frame: up to 2 weeks

  3. 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

  4. Standard reporting of adverse events (AEs) for safety assessment

    Time frame: 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).

Sponsors and collaborators

Lead sponsor

Société des Produits Nestlé (SPN)

Industry

Collaborators

  • Kamuzu University of Health Sciences
  • Swiss Federal Institute of Technology

Registry information

Official study title

Iron Bioavailability From Fortified Cereal in Malawian Infants

Important dates

Study start
2019
Primary completion
2019
Study completion
2019
First posted
Nov 27, 2018
Registry last updated
Jul 16, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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