Ignite Creation Date:
2024-05-05 @ 4:56 PM
Last Modification Date:
2024-10-26 @ 9:25 AM
Study NCT ID:
NCT00340652
Status:
COMPLETED
Last Update Posted:
2019-12-17
First Post:
2006-06-19
Brief Title:
Effects of Infant Diets on Estrogen Activity and Development
Sponsor:
National Institute of Environmental Health Sciences NIEHS
Organization:
National Institutes of Health Clinical Center CC
Study Overview
Official Title:
Study of Estrogen Activity Development SEAD - SEAD 1 Sonography
Status:
COMPLETED
Status Verified Date:
2012-08-22
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This study conducted at the Childrens Hospital of Boston and the Brigham and Womens Hospital in Boston will examine the natural history of infant development in the first year of life and how different types of infant feeding may affect that development During pregnancy babies are exposed to the female hormone estrogen from their mothers Estrogen affects development of breasts and milk production as well as the development of the uterus ovaries and possibly other hormonally responsive organs in both males and females Between 6 and 12 months of age the effects are reduced Breast milk and some infant formulas may contain compounds that can act like female hormones in the body and may prolong the estrogen effects This study will examine the natural history of estrogen activity in infants on different feeding regimens breast milk cows milk and soy milk and will serve as preparation for a larger study of the effects of soy formula on estrogen activity in infants
Full-term female babies 37 to 41 weeks gestational age at birth from 0 to 12 months of age and male babies from birth to 6 months of age who weigh from 2501 to 4499 grams about 55 to 10 pounds at birth and who have no chromosomal abnormalities major malformations or endocrine problems may be eligible for this study Males must have palpable testes Babies being fed a diet of breast milk soy milk or cows milk will be included Study procedures include the following
History of the babys dietary intake since birth provided by the parent
Ultrasound measurement of the uterus ovaries and breasts in female babies the testes prostate and breasts in males and the thymus thyroid and kidneys in all babies
Measurements of all babies weight length and head circumference
Full-term female babies 37 to 41 weeks gestational age at birth from 0 to 12 months of age and male babies from birth to 6 months of age who weigh from 2501 to 4499 grams about 55 to 10 pounds at birth and who have no chromosomal abnormalities major malformations or endocrine problems may be eligible for this study Males must have palpable testes Babies being fed a diet of breast milk soy milk or cows milk will be included Study procedures include the following
History of the babys dietary intake since birth provided by the parent
Ultrasound measurement of the uterus ovaries and breasts in female babies the testes prostate and breasts in males and the thymus thyroid and kidneys in all babies
Measurements of all babies weight length and head circumference
Detailed Description:
Term newborns have anatomic and sonographic evidence of in utero estrogen exposure Over the first six months to a year of life as the influence of maternal hormone wanes these findings recede Soy infant formula contains large amounts of isoflavones daidzein and genistein that can occupy estrogen receptors and act as estrogens in the laboratory A food substance with estrogen activity might prolong the effect of maternal hormones or interfere with hormonal homeostasis in the child This cross-sectional pilot study will be undertaken in order to establish methods for a future multi center study designed to assess the potential effects of soy formula on estrogen activity in infants In this pilot study SEAD 1 156 examinations on full-term infants ages 0-12 months and on one of three feeding regimens soy formula breast milk or cows milk formula will be completed to see if their exposure to soy estrogen compared to breast milk and non-soy formulas prolongs anatomical evidence of estrogen exposure and response A schedule of visits for SEAD 1 is included in Appendix A In addition to SEAD 1 two other cross-sectional studies SEAD 2 and SEAD 3 will be undertaken to evaluate anatomical evidence by physical examination SEAD 2 and assess the hormonal and biochemical status of full-term infants ages 0-12 months SEAD 3 These studies will be conducted at Childrens Hospital of Philadelphia CHOP in parallel with the SEAD 1 study Further details of SEAD 2 and 3 will not be presented in this protocol The purpose of the SEAD 1 pilot study is twofold The first is to develop and finalize recruitment and collections procedures in preparation for a larger comprehensive trial of biological response in children to soy formula with and without the estrogenic isoflavones The second is to study the natural history of estrogen activity in infants on a variety of feeding regimens
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 03-E-N287 | None | None | None |