Influence of Improved Formula on Fatty Acids and Mineral Metabolism in Infants

October 29, 2015 updated by: Beingmate Baby & Child Food Co Ltd .
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

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

90

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
      • Shanghai, China
        • Recruiting
        • Shanghai Children's Medical Center
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

No older than 1 week (Child)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Healthy full term infants

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Improved Infant Formula Group
Containing β-Palmitate Content
Other: β-Palmitate Content
Placebo Comparator: General Infant Formula Group
Excluding β-Palmitate Content
Other: Placebo
Active Comparator: Human Milk Group
Containing β-Palmitate Content Naturely in Human Milk
Other: β-Palmitate Content Naturely in Human Milk

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Content of fatty acids
Time Frame: 3 years
3 years
Content of calcium and magnesium
Time Frame: 3 years
3 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Anthropometric measurements
Time Frame: 3 years
Index of anthropometric measurements contains weight,height and head circumference.
3 years
Stool characteristics assessed via stool frequency
Time Frame: 3 years
3 years
Stool characteristics assessed via stool consistency
Time Frame: 3 years
3 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Beingmate Baby & Child Food Co Ltd .

Collaborators

Shanghai Jiao Tong University School of Medicine

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2013

Primary Completion (Anticipated)

December 1, 2015

Study Registration Dates

First Submitted

October 20, 2015

First Submitted That Met QC Criteria

October 26, 2015

First Posted (Estimate)

October 27, 2015

Study Record Updates

Last Update Posted (Estimate)

November 1, 2015

Last Update Submitted That Met QC Criteria

October 29, 2015

Last Verified

October 1, 2015

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • RDM2012002

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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