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Main
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Note: This record shows only the 20 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 January 2013 |
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Main ID: |
NCT00340665 |
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Date of registration:
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19/06/2006 |
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Primary sponsor: |
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Public title:
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Study of Infant Diets on Estrogen Activity and Development
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Scientific title:
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Study of Estrogen Activity & Development (SEAD) SEAD2: Physical Exam and Ballard Markers; Sead 3: Biochemistry |
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Date of first enrolment:
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May 2003 |
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Target sample size:
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456 |
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Recruitment status: |
Completed |
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URL:
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http://clinicaltrials.gov/show/NCT00340665 |
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Study type:
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Observational |
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Study design:
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N/A
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Countries of recruitment
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United States
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Contacts
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Name:
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Donna D Baird, Ph.D. |
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Address:
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Telephone:
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Email:
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Affiliation:
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National Institute of Environmental Health Sciences (NIEHS) |
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Key inclusion & exclusion criteria
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- INCLUSION CRITERIA:
SEAD 2 and 3
1. Full term infants defined as age 37-41 weeks gestational age at birth. Ultrasound
evidence or reliable reporting of last menstrual period (LMP) by infant's mother.
2. Can be categorized into one of the feeding definitions.
3. Birth weight between 2501-4499 grams.
4. Age 0-6 months for SEAD 2, age 0-12 months for SEAD 3
5. For SEAD 3, for 12-months age interval, subjects must not have had first haircut.
EXCLUSION CRITERIA:
SEAD 2 and 3
1. Chromosomal aberrations
2. Major malformation
3. SEAD 2: Non-palpable testis (males only)
4. Presence of an endocrinopathy (i.e., ambiguous genitalia, congenital hypothyroidism)
This is a natural history study and children must be healthy in order to participate in
this study. Therefore, children will be excluded from the study if they are known to have
chromosomal aberrations, or any major malformations or an endocrinopathy. Testicular
development is an important endpoint in this study and therefore males will be excluded
from SEAD 2 if the testes are not palpable.
Age minimum:
N/A
Age maximum:
1 Year
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Estrogen Activity
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Infant Formula
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Secondary ID(s)
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03-E-N184
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999903184
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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