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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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7 April 2015 |
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Main ID: |
NCT00820833 |
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Date of registration:
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08/01/2009 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Effect of Formula on Growth of Infants From Overweight or Obese Mothers
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Scientific title:
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Effect of Protein Levels and Caloric Density on the Growth of Formula Fed Infants From Overweight or Obese Mothers |
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Date of first enrolment:
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October 2007 |
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Target sample size:
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230 |
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Recruitment status: |
Completed |
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URL:
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http://clinicaltrials.gov/show/NCT00820833 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
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Phase:
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N/A
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Countries of recruitment
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Chile
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Contacts
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Name:
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Jaime Inostroza, PhD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Universidad de la Frontera |
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Key inclusion & exclusion criteria
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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
Age minimum:
3 Months
Age maximum:
12 Months
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Infant Nutrition
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Intervention(s)
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Other: standard infant formula
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Other: Test formula
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Primary Outcome(s)
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mean weight gain
[Time Frame: 3 months]
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Secondary Outcome(s)
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blood test assessments; body composition, bone density
[Time Frame: 9 months]
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Secondary ID(s)
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05.29.INF
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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