NCT03754543

Baby Iron Bioavailability Study

Iron Bioavailability From Fortified Cereal in Malawian Infants

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 30 (actual)
• Sponsor: Société des Produits Nestlé (SPN) · Industry
• Sex: All
• Age: 6 Months – 14 Months
• Healthy volunteers: Accepted

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.

Conditions

• Iron Bioavailability

Interventions

Type	Name	Description
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
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
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

Timeline

• Start date: 2019-01-31
• Primary completion: 2019-06-12
• Completion: 2019-06-12
• First posted: 2018-11-27
• Last updated: 2019-07-16

Locations

1 site across 1 country: Malawi