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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00820833
Other study ID # 05.29.INF
Secondary ID
Status Completed
Phase N/A
First received January 8, 2009
Last updated March 25, 2015
Start date October 2007
Est. completion date December 2014

Study information

Verified date December 2014
Source Nestlé
Contact n/a
Is FDA regulated No
Health authority Chile: Comisión Nacional de Investigación Científica y Tecnológica
Study type Interventional

Clinical Trial Summary

The purpose of this study is to determine whether infants, from overweight or obese mothers, fed a formula with proteins and calories different than a standard infant formula have a different growth


Recruitment information / eligibility

Status Completed
Enrollment 230
Est. completion date December 2014
Est. primary completion date June 2010
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 3 Months to 12 Months
Eligibility Inclusion Criteria:

- healthy newborn infant

- birth weight between 2500g and 4800g

- singleton birth

- mother's BMI before pregnancy was between 26 and 25

- for the breastfeeding group: mother has elected to exclusively breastfeed her baby from birth to at least 6 months of age

- for the formula groups: mother has elected to exclusively formula feed her baby from 3 to 6 months of age

- having obtained signed informed consent of legal representative

Exclusion Criteria:

- body weight smaller than 5th percentile for that gestational age

- newborn whose mother has diabetes

- newborn whose mother has a drug dependence during pregnancy

- newborn currently participating in another trial

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)


Related Conditions & MeSH terms


Intervention

Other:
standard infant formula
standard infant formula given from 3 to 12 months of age, as per standard requirement
Test formula
Test formula with different protein and calorie content than standard formula, given from 3 to 12 months of age. As per standard requirement.

Locations

Country Name City State
Chile Departamento de Medicina Interna, University de la Frontera Temuco

Sponsors (1)

Lead Sponsor Collaborator
Nestlé

Country where clinical trial is conducted

Chile, 

Outcome

Type Measure Description Time frame Safety issue
Primary mean weight gain 3 months Yes
Secondary blood test assessments; body composition, bone density 9 months Yes
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