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The Effects of a2 Infant Formula on Growth and Tolerance in Healthy Term Infants

NCT06256094 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 280

Last updated 2024-02-13

No results posted yet for this study

Summary

This is a randomized, open-label, prospective study to evaluate the nutritive effects of an a2 infant formula on growth and tolerance in healthy term infants. A total of 280 healthy, term, mixed-fed infants between 60 and 120 days of age were enrolled at Shanghai. The participants were randomly assigned to one of the two study groups: the a2 infant formula group and the conventional A1/A2 infant formula group. Each group contained 140 infants. The study duration was 56 days.

Conditions

  • Healthy

Interventions

DIETARY_SUPPLEMENT

a2 Platinum Premium Infant Formula Stage 1

Oral intake of a2 Platinum Premium Infant Formula Stage 1 milk powder (dissolved in water)

DIETARY_SUPPLEMENT

Frisolac Infant Formula Stage 1 (Dutch Edition)

Oral intake of Frisolac Infant Formula Step 1 (Dutch Edition) milk power (dissolved in water)

Sponsors & Collaborators

  • a2 Milk Company Ltd.

    lead INDUSTRY

Principal Investigators

  • Frank Wang · Adjuvant Advertising (Shanghai) Co., Ltd

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
60 Days
Max Age
120 Days
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2023-07-14
Primary Completion
2023-11-03
Completion
2023-11-03

Countries

  • China

Study Locations

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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 NCT06256094 on ClinicalTrials.gov