Efficacy and Tolerance of a Follow-On Formula Fed to Children From 36-48 Months of Age

Acute Respiratory Infection Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01488435
• Other study ID #: 6012
• Status: Completed
• Phase: N/A
• First received: December 5, 2011
• Last updated: December 5, 2012
• Start date: November 2011
• Est. completion date: June 2012

Study information

• Verified date: December 2012
• Source: Mead Johnson Nutrition
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Shanghai Nutrition Society IRB
• Study type: Interventional

Clinical Trial Summary

The purpose is to determine if the consumption of study product has an effect on acute respiratory infections and/or diarrheal disease.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 310
• Est. completion date: June 2012
• Est. primary completion date: June 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 36 Months to 48 Months

Eligibility

Inclusion Criteria:

• Child 36-48 months of age

• Child is currently attending a daycare and has attended for 6 months or less

• Has consumed cow's milk or a cow's milk-based beverage during the 48 hours prior to randomization

• Signed informed consent

Exclusion Criteria:

• Child who received any food product or supplement containing probiotics or prebiotics in the 15 days prior to randomization

• Child with allergy to gluten or serious concurrent illness that will interfere in the general management of the child

• Child with diarrhea or acute respiratory infection during the 48 hours prior to randomization

• Child's z-score of weight for height < -3 according to World Health Organization criteria

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Acute Respiratory Infection
• Diarrheal Disease
• Respiratory Tract Infections

Intervention

Dietary Supplement:
• Cow's milk
Powdered whole cow's milk
• Follow-On Formula
Powdered Follow-On Formula with added long-chain Polyunsaturated fatty acid, prebiotics, and polysaccharide

Locations

Country	Name	City	State
China	Shi-ji-xing Child Care Center, Jin Dong District	Jinhua	Zhejiang

Sponsors (3)

Lead Sponsor	Collaborator
Mead Johnson Nutrition	Shanghai Children Medical Center, Shanghai, China

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Acute respiratory infections and diarrheal disease		28 weeks	No
Secondary	Allergic manifestations		28 weeks	No
Secondary	Systemic antibiotic use		28 weeks	No
Secondary	Duration of acute respiratory infection and diarrheal disease		28 weeks	No
Secondary	Changes in stool patterns		Baseline and 28 weeks	No
Secondary	Fecal immune markers		Baseline and 28 weeks	No
Secondary	Serum Ferritin status		Baseline and 28 weeks	No
Secondary	Incidence of stool parasites		Baseline and 28 weeks	No
Secondary	Growth		28 weeks	No
Secondary	Adverse events	The incidence of any adverse event for each participant	28 weeks	No
Secondary	Acceptance of study product	Acceptance of study product based on quantity consumed.	28 weeks	No
Secondary	Serum immune markers		Baseline and 28 weeks	No
Secondary	Serum zinc status		Baseline and 28 weeks	No