MedTrace Logo

Safety and Nutritional Adequacy of a New Infant Formula in Healthy Term Infants

NCT04013087 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 450

Last updated 2020-04-24

No results posted yet for this study

Summary

This study is a multicenter, double-blind, randomized, controlled, parallel-designed, prospective study and is intended to evaluate the nutritional adequacy and tolerance of a new study formula compared with a concurrent control formula. Approximately 450 infants will be enrolled from approximately 3 China sites. Of these infants, approximately 300 will be randomized 1:1 to receive an investigational formula or a control formula for 16weeks of feeding. The remaining approximately 150 infants will be enrolled as a breastfeeding reference group. The primary outcome measure is the rate of weight gain in g/day between baseline and 16 weeks in the test group compared to control formula group. Participants will have the option of providing stool samples at 8 weeks and 16 weeks for analysis of microbiota and metabolomics. The study period will be 16 weeks, and all infants in the 2 formula groups will receive formula free of charge for 6 months.

Conditions

  • Child Development

Interventions

DIETARY_SUPPLEMENT

Oral feeding of Feihe Stage 1 infant formula

Oral feeding of Feihe Stage 1 infant formula for 16 weeks

DIETARY_SUPPLEMENT

Oral feeding of control Stage 1 formula

Oral feeding of control Stage 1 formula for 16 weeks (A commercially available product with comparable composition but does not contain sn-2 palmitate enriched vegetable oil as an ingredient (regular vegetable oil is used))

DIETARY_SUPPLEMENT

Breast feeding

Breast feeding of human milk for 16 weeks

Sponsors & Collaborators

  • Heilongjiang Feihe Dairy Co. Ltd.

    lead INDUSTRY

Principal Investigators

  • Fei Li, PhD · Xinhua Hospital, Shanghai Jiao Tong University School of Medicine

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
10 Days
Max Age
14 Days
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2019-07-08
Primary Completion
2020-04-19
Completion
2020-12-30

Countries

  • China

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 NCT04013087 on ClinicalTrials.gov