Clinical Trials Logo
  1. Home
  2. Healthy Infants
  3. NCT03014115

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

Healthy Infants Clinical Trial

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

Clinical Trial 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.

Clinical Trial 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. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT03014115
Study type Interventional
Source DSM Nutritional Products, Inc.
Contact
Status Completed
Phase N/A
Start date November 2016
Completion date August 2019
View Details
See also
  Status Clinical Trial Phase
Completed NCT03679234 - Impact of Infant Formula on Caregiver-perceived Intolerance N/A
Completed NCT01681355 - Gastrointestinal Tolerance Study of a New Infant Formula N/A
Completed NCT04962594 - Safety and Efficacy of Infant Formulas Supplemented With Pre- and Probiotic(s) N/A
Completed NCT03722550 - Second Generation Human Milk Oligosaccharides Blend Study N/A
Completed NCT03703583 - Infant Feeding Practice and Gut Comfort Study
Completed NCT01515644 - Study on the Effect of Inulin in Infant Formula on Gut Health Phase 3
Recruiting NCT06053112 - The Trial of a New Infant Formula in Healthy Term Chinese Infants N/A
Completed NCT03000543 - Novel Isotope Dilution Technique to Assess Vitamin A Status N/A
Not yet recruiting NCT06361719 - Efficacy of Two HMOs in Chinese Infants N/A
Terminated NCT03976596 - Measurement of in Vivo Mitochondrial Capacity in Infants
Recruiting NCT01601197 - A Study of Two Injection Techniques to Reduce Pain in Infants Undergoing Immunization Phase 3
Completed NCT01635816 - Immunogenicity of SA 14-14-2 JE Vaccine Phase 4
Completed NCT01633216 - Poliovirus Vaccine Trial in Bangladesh Phase 4
Completed NCT00957892 - Effects of Infant Formula Composition on Infant Feeding Behaviors N/A
Completed NCT03801161 - Influence of Inflammation on Micronutrient Status Assessment N/A
Active, not recruiting NCT06073652 - Starter Infant Formula With Synbiotics N/A
Completed NCT01825109 - Improving Rotavirus Vaccine Immune Response Phase 3
Completed NCT01594840 - Changing Chat: Diaper Tips to Improve Language Development N/A
Withdrawn NCT01507935 - Colonisation Resistance Study Phase 2
Not yet recruiting NCT01249911 - Lactobacillus Reuteri DSM 17938 and Prevention of Respiratory and Gastrointestinal Infections in Mexican Infants Phase 3