NCT02437721

Suitability of an Infant Formula With L-5-Methyltetrahydrofolate for the Particular Nutritional Use in Infants

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 360 (actual)
• Sponsor: dsm-firmenich Switzerland AG · Industry
• Sex: All
• Age: 1 Day – 27 Days
• Healthy volunteers: Accepted

Summary

The study is designed to show equivalence of an infant formula containing L-5- Methyltetrahydrofolate (MTHF) compared to a standard infant formula containing folic acid in respect to weight gain of healthy term infants receiving these infant formulae exclusively during the first 4 months of life. Healthy non breast fed infants will be randomized to receive either a standard infant formula with folic acid or a corresponding formula with MTHF instead of folic acid. Besides weight and length further anthropometric measures will be taken monthly from the age of 4 weeks to the age of 16 weeks and at the age 4 and 16 weeks blood samples will be taken for the determination of folate status and genotyping. As a reference the same measures will be taken in a group of breast fed infants, whose mothers' folate status will be determined as well.

Conditions

• Growth and Development

Interventions

Type	Name	Description
OTHER	infant formula containing folic acid
OTHER	infant formula containing MTHF

Timeline

• Start date: 2015-05-01
• Primary completion: 2017-08-01
• Completion: 2018-03-01
• First posted: 2015-05-08
• Last updated: 2018-08-10

Locations

2 sites across 1 country: Serbia