Effect of the Level of Dietary Protein on Infant Growth

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

405 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-08-31

Study Completion Date

2015-02-28

Brief Summary

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The purpose of this study is to determine whether infants fed a formula with protein levels different than a standard infant formula have similar growth and development.

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Detailed Description

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Conditions

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Infant Nutrition

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Control

Standard Infant Formula

Group Type PLACEBO_COMPARATOR

Standard infant formula

Intervention Type OTHER

From 3 to 12 months of age. As per standard requirement

Test Product

Infant formula with different level of proteins

Group Type EXPERIMENTAL

Infant formula with different level of proteins

Intervention Type OTHER

From 3 to 12 months of age. As per standard requirement

Breast Milk

Breastfeeding reference group

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Standard infant formula

From 3 to 12 months of age. As per standard requirement

Intervention Type OTHER

Infant formula with different level of proteins

From 3 to 12 months of age. As per standard requirement

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Gestational age at least 37 weeks
* Singleton birth
* Birth weight between 2500g and 4500g
* Weight at enrolment is at or above the 5th percentile (CDC)
* Infant has been exclusively formula fed for at least the last 14 days
* Having obtained informed consent of legal representative

Exclusion Criteria

* Congenital illness or malformation that affects infant feeding and/or growth
* Significant pre-natal and/or post-natal disease
* Suspected or confirmed allergy to cow milk protein
* In the investigators assessment, infant's family cannot be expected to comply with treatment (feeding regimen)
* Currently participating in another clinical trial

Minimum Eligible Age

3 Months

Maximum Eligible Age

12 Months

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes