NCT03014115

Effects of Different ARA Formulations of Infant Formula on Fatty Acid Status, Immune Markers and Infection Rates in Infants

EFFECTS OF DIFFERENT ARA FORMULATIONS OF INFANT FORMULA ON FATTY ACID STATUS, IMMUNE MARKERS AND INFECTION RATES IN INFANTS

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 110 (actual)
• Sponsor: dsm-firmenich Switzerland AG · Industry
• Sex: All
• Age: 22 Weeks – 26 Weeks
• Healthy volunteers: Accepted

Summary

The clinical trial will investigate the effect of different formulations of ARA + 0.4% DHA in infant formula on plasma fatty acid status in healthy 6 months old infants supplemented for 6 months. A 6-month follow on phase will provide additional efficacy (e.g. infection rates, immune markers) and safety information in these 12-18 month old infants.

Detailed description

This study is a randomized, double-blind, parallel-group study of 0% ARA +0.4% DHA or 0.76% ARA +0.4% DHA supplemented infant formula provided to 6 months old healthy infants for 6 months. Infants will have been breast-fed or formula-fed prior to enrollment. The difference in total plasma fatty acid ARA levels between the two groups at 6 months of supplementation will be measured. Parents will be asked about the infant's current daily diet (fatty acid intakes calculated via 24 hour recalls). All completed infants will be enrolled into a 6 month extension period (non-supplemented) to collect additional measures of efficacy (i.e. infections and illnesses, immune markers) and safety out to 18 months of age.

Conditions

• Healthy Infants

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	combination ARA + DHA	combination ARA + DHA supplemented infant formula
DIETARY_SUPPLEMENT	DHA	DHA supplemented infant formula

Timeline

• Start date: 2016-11-01
• Primary completion: 2019-05-01
• Completion: 2019-08-01
• First posted: 2017-01-09
• Last updated: 2020-01-18

Locations

2 sites across 1 country: Spain