a2 growing up stage 3 formula puls lactoferrin supplement
Dietary SupplementThe participants in this group will consume 4-5 scoops (8.5g/scoop) of the assigned formula each time, and 4 times per day
NCT Number: NCT05670678
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
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Notify Me2 year–3 year
All sexes
Observational
Nan Quan Community Hospital, Jinhua, Zhejiang, China
This study is two arms, opening parallel-designed, observational study. Diarrheal and infectious episodes, including acute upper and lower respiratory infections (ARI), changes in stool patterns, use of systemic antibiotics, adverse events and study formula consumption will be compared in children 2 - 3 years of age who are assigned to receive one of the two following study formulas for a 3-month feeding period: a2 growing up stage 3 formula puls lactoferrin supplement and Enfinitas growingup stage 3 formula.
200 children eligible for the study will be enrolled from two study sites and randomly assigned to two groups to feed for 90 days. About 160 children (80 for each group) are expected to finish the study, and data of primary and secondary outcomes will be collected during the four visits across the study. A sample size of 80 completed per group is needed to achieve a 80% power.
The Andersen-Gill model will be used to model the primary outcome (recurrent event of either diarrheal disease or an acute respiratory infection) under the framework of the proportional hazard assumption. For other secondary outcomes such as duration of acute respiratory infections(ARI) and/or diarrheal disease, episodes of systemic antibiotic use,amount of study formula consumed,changes in stool pattern and cost of treatment will also be analyzed.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
The participants in this group will consume 4-5 scoops (8.5g/scoop) of the assigned formula each time, and 4 times per day
The participants in this group will consume 4 scoops (10g/scoop) of the assigned formula each time, and 3 times per day
Time frame: baseline day 0, day 90
Change of frequency of acute respiratory infection (ARI) and/or diarrheal disease from baseline to 3 months
Time frame: baseline day 0, visit 1 day 30, visit 2 day 60, visit 4 day 90
Number of days with acute respiratory infections(ARI) and/or diarrheal disease for each visit
Time frame: baseline day 0, visit 1 day 30, visit 2 day 60, visit 4 day 90
Number of days of antibiotics treated for each visit interval
Time frame: baseline day 0, visit 1 day 30, visit 2 day 60, visit 4 day 90
Amount of study formula consumed (in grams)
Time frame: baseline day 0, visit 1 day 30, visit 2 day 60, visit 4 day 90
Average number of bowel movements per week and stool consistency
Time frame: baseline day 0, visit 1 day 30, visit 2 day 60, visit 4 day 90
Cost of medical treatment in RMB yuan for each visit interval
a2 Milk Company Ltd.
Industry
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
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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