NCT02621814

Brief Summary

Compared with breast milk and another commercially available formula, infants' growth rate after 12 weeks' Friso formula with low glycation feeding will be assessed.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
224

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started May 2016

Shorter than P25 for not_applicable

Geographic Reach
1 country

6 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 2, 2015

Completed
2 days until next milestone

First Posted

Study publicly available on registry

December 4, 2015

Completed
5 months until next milestone

Study Start

First participant enrolled

May 6, 2016

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 30, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 30, 2016

Completed
Last Updated

April 4, 2018

Status Verified

April 1, 2018

Enrollment Period

6 months

First QC Date

December 2, 2015

Last Update Submit

April 2, 2018

Conditions

Body Weight Changes

Keywords

InfantGrowthBody Weight ChangesInfant FormulaRandomized Controlled Trial

Outcome Measures

Primary Outcomes (3)

  • Growth rate of height

    (The height at the end of 12 weeks after feeding minus the height before feeding)/3

    At the end of 12 weeks after feeding

  • Growth rate of weight

    (The weight at the end of 12 weeks after feeding minus the weight before feeding)/3

    At the end of 12 weeks after feeding

  • Growth rate of head circumference

    (The head circumference at the end of 12 weeks after feeding minus the head circumference before feeding)/3

    At the end of 12 weeks after feeding

Secondary Outcomes (15)

  • Growth rate of height

    At the end of 4 weeks after feeding

  • Growth rate of height

    At the end of 8 weeks after feeding

  • Growth rate of weight

    At the end of 4 weeks after feeding

  • Growth rate of weight

    At the end of 8 weeks after feeding

  • Growth rate of head circumference

    At the end of 4 weeks after feeding

  • +10 more secondary outcomes

Study Arms (2)

Experimental 1

EXPERIMENTAL

Formula feeding

Dietary Supplement: Low glycation formula feeding

Experimental 2

EXPERIMENTAL

Formula feeding

Dietary Supplement: Commercially common formula feeding

Interventions

Low glycation formula feedingDIETARY_SUPPLEMENT

Formula feeding on demand for 3 months

Experimental 1
Commercially common formula feedingDIETARY_SUPPLEMENT

Formula feeding on demand for 3 months

Experimental 2

Eligibility Criteria

Age4 Weeks - 8 Weeks
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • to 2 months-old term infants (gestational age ≥37 weeks) checked-up in child care department
  • Gender not limited
  • Though completely understanding the importance of breast milk feeding, subjects' mothers cann't continue to give breast milk feeding owing to their own problems, and have to feed infants with foumula milk only
  • Legal guardians of subjects know the objective of this study and get the tested formula milk for free, then volunteer to participate in the study and sign an informed consent

You may not qualify if:

  • Infants' mothers suffered from infectious diseases during pregnancy
  • Subjects suffered from basic diseases (such as congenital heart disease and genetic metabolic diseases) and congenital deformity
  • Brain damage caused by a variety of factors such as HIE, intraventricular hemorrhage, hypoglycemia
  • Small for gestational age
  • Subjects cann't get full enteral feeding, such as NEC
  • Subjects allergic to cow's milk protein
  • Drop-out Criteria:
  • Subjects in violation of this trial plan (using the other brand formula or not according to the plan)
  • Loss of follow-up
  • Withdrawing the informed consent or asked to quit on their own

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (6)

Z1

Zhangzhou, Fujian, 363000, China

Location

Z2

Zhangzhou, Fujian, 363000, China

Location

H2

Haikou, Hainan, 570102, China

Location

H1

Haikou, Hainan, 570206, China

Location

BJ1

Baoji, Shanxi, 721000, China

Location

BJ2

Baoji, Shanxi, 722300, China

Location

MeSH Terms

Conditions

Body Weight Changes

Condition Hierarchy (Ancestors)

Body WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Chongfan Zhang, Bachelor

    Children's Hospital of Fudan University

    STUDY DIRECTOR

  • Wei Xiang, Master

    Maternal and Child Health Hospital of Hainan Province

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 2, 2015

First Posted

December 4, 2015

Study Start

May 6, 2016

Primary Completion

October 30, 2016

Study Completion

October 30, 2016

Last Updated

April 4, 2018

Record last verified: 2018-04

Data Sharing

IPD Sharing
Will share

Locations

CN(6)