CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 200 enrolled
Drug / intervention
a2 growing up stage 3 formula puls lactoferrin supplement +1 moredietary
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT05670678
NCT05670678N/ACompleted

Improved Respiratory Infection Outcomes Associated With Lactoferrin Fortified a2 Growing up Formula Consumption in Children of 2 to 3 Year Old: a Randomized, Open Label Trial

a2 Milk Company Ltd.·observational·Posted Jan 4, 2023·Updated Feb 29, 2024

In Brief

An observational study evaluating a2 growing up stage 3 formula puls lactoferrin supplement and Enfinitas growing up stage 3 formula for Respiratory Infection and Diarrheal Disease. Completed, enrolled 200 participants across 2 sites.

Detailed Summary

The goal of this observational study is to compare the incidence of ARI and/or diarrheal disease associated with feeding different formulas with and without lactoferrin supplement in children of 2-3 years old. 200 children eligible for the study will be enrolled from two study sites and randomly assigned to two groups (a2 growing up stage 3 formula puls lactoferrin supplement, and Enfinitas growing up stage 3 formula) to feed for 90 days. About 160 children (80 for each group) are expected to finish the study, and data will be collected during the four visits across the study. Researchers will compare the two groups to see if there is significant decrease of the occurrence of diarrheal disease and/or acute respiratory infection for children fed with a2 growing up stage 3 formula puls lactoferrin supplement

Study Details

Study Typeobservational
Allocation--
Masking--
Primary Purpose--
CountriesChina

Timeline

N/ACompletedFinished
2023202420252026
First PostedJan 4, 2023
Enrollment StartDec 19, 2022
Primary CompletionMay 17, 2023
TodayJul 2, 2026
Enrollment to primary: 5 monthsPosted 3.5 years ago

Interventions

a2 growing up stage 3 formula puls lactoferrin supplementdietary

The participants in this group will consume 4-5 scoops (8.5g/scoop) of the assigned formula each time, and 4 times per day

Enfinitas growing up stage 3 formuladietary

The participants in this group will consume 4 scoops (10g/scoop) of the assigned formula each time, and 3 times per day