NCT02587702

Brief Summary

The purpose of this study is to determine whether different content of β-palmitate will cause significant differences on Fatty Acids and Mineral Metabolism in Infants

Trial Health

55
Monitor

Trial Health Score

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

Enrollment
90

participants targeted

Target at P75+ for not_applicable healthy

Geographic Reach
1 country

1 active site

Status
unknown

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

Study Start

First participant enrolled

June 1, 2013

Completed
2.4 years until next milestone

First Submitted

Initial submission to the registry

October 20, 2015

Completed
7 days until next milestone

First Posted

Study publicly available on registry

October 27, 2015

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2015

Completed
Last Updated

November 2, 2015

Status Verified

October 1, 2015

Enrollment Period

2.5 years

First QC Date

October 20, 2015

Last Update Submit

October 29, 2015

Conditions

Healthy

Keywords

Term Infants

Outcome Measures

Primary Outcomes (2)

  • Content of fatty acids

    3 years

  • Content of calcium and magnesium

    3 years

Secondary Outcomes (3)

  • Anthropometric measurements

    3 years

  • Stool characteristics assessed via stool frequency

    3 years

  • Stool characteristics assessed via stool consistency

    3 years

Study Arms (3)

Improved Infant Formula Group

EXPERIMENTAL

Containing β-Palmitate Content

Other: β-Palmitate Content

General Infant Formula Group

PLACEBO COMPARATOR

Excluding β-Palmitate Content

Other: Placebo

Human Milk Group

ACTIVE COMPARATOR

Containing β-Palmitate Content Naturely in Human Milk

Other: β-Palmitate Content Naturely in Human Milk

Interventions

β-Palmitate ContentOTHER
Improved Infant Formula Group
PlaceboOTHER
General Infant Formula Group
β-Palmitate Content Naturely in Human MilkOTHER
Human Milk Group

Eligibility Criteria

AgeUp to 7 Days
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • Healthy full term infants

You may not qualify if:

  • experienced congenital or chromosomal disorders
  • neonatal morbidities, or metabolic illness

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Shanghai Children's Medical Center

Shanghai, China

RECRUITING

MeSH Terms

Interventions

Milk, Human

Intervention Hierarchy (Ancestors)

MilkBeveragesDiet, Food, and NutritionPhysiological PhenomenaDairy ProductsFoodFood and Beverages

Central Study Contacts

Fei Bei, Master

CONTACT

86-21-38625778Fionabei@163.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
CARE PROVIDER, INVESTIGATOR
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 20, 2015

First Posted

October 27, 2015

Study Start

June 1, 2013

Primary Completion

December 1, 2015

Last Updated

November 2, 2015

Record last verified: 2015-10

Locations

CN(1)