Baby Iron Bioavailability Study

NCT03754543 | Completed

• 1 other identifier: 18.05.INF
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Iron Bioavailability

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

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

  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

  time of consent to 24 hours after final blood draw

Study Arms (5)

Testmeal A

ACTIVE COMPARATOR

A new, whole-grain infant cereal fortified with ferrous fumarate

Other: Labeled iron salt Fe54

Testmeal B

ACTIVE COMPARATOR

An alternative new whole-grain infant cereal recipe fortified with ferrous fumarate

Other: Labeled iron salt Fe57

Testmeal C

PLACEBO COMPARATOR

An existing, refined grain infant cereal fortified with ferrous fumarate

Other: Labeled iron salt Fe54

Testmeal D

ACTIVE COMPARATOR

An existing, whole-grain infant cereal fortified with ferrous fumarate

Other: Labeled iron salt Fe57

Testmeal E

ACTIVE COMPARATOR

An existing, whole-grain infant cereal fortified with ferrous bisglycinate

Other: Labeled iron salt Fe58

Interventions

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

Testmeal A; Testmeal C

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

Testmeal B; Testmeal D

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

Testmeal E

Eligibility Criteria

• Age: 6 Months - 14 Months
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Société des Produits Nestlé (SPN): lead
• Swiss Federal Institute of Technology: collaborator
• Kamuzu University of Health Sciences: collaborator

Study Sites (1)

Central Hospital

Zomba, Malawi

Location

Study Officials

• Kamija Phiri, Prof.

  Kamuzu University of Health Sciences

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 4, 2018
• First Posted: November 27, 2018
• Study Start: January 31, 2019
• Primary Completion: June 12, 2019
• Study Completion: June 12, 2019
• Last Updated: July 16, 2019

Record last verified: 2019-07

Data Sharing

• IPD Sharing: Will not share

Locations

MA (1)