MedTrace Logo

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

NCT03014115 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 110

Last updated 2020-01-18

No results posted yet for this study

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.

Conditions

  • Healthy Infants

Interventions

DIETARY_SUPPLEMENT

combination ARA + DHA

combination ARA + DHA supplemented infant formula

DIETARY_SUPPLEMENT

DHA

DHA supplemented infant formula

Sponsors & Collaborators

  • SynteractHCR

    collaborator INDUSTRY

  • DSM Nutritional Products, Inc.

    lead INDUSTRY

Principal Investigators

  • Ascension Marcos, PhD · Instituto de Ciencia y Tecnología de Alimentos y Nutrición

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
22 Weeks
Max Age
26 Weeks
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2016-11-30
Primary Completion
2019-05-31
Completion
2019-08-31

Countries

  • Spain

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03014115 on ClinicalTrials.gov