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NCT00340652 · ClinicalTrials.gov registry record

Effects of Infant Diets on Estrogen Activity and Development

A clinical trial, sponsored by National Institute of Environmental Health Sciences (NIEHS).

Completed
Registry status
157
Enrollment target

NCT00340652 is a clinical trial that has completed, run by National Institute of Environmental Health Sciences (NIEHS). The registered enrollment target is 157 participants.

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The verdict

NCT00340652 has completed, sponsored by National Institute of Environmental Health Sciences (NIEHS).

COMPLETED
Registry status
157 participants
Enrollment target

Study Summary

This study, conducted at the Children's Hospital of Boston and the Brigham and Women's 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, cow's 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 5.5 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 cow's milk will be included. Study procedures include the following: * History of the baby's 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.

Trial Details

FieldValue
Enrollment Target 157 participants
Start Date 2003-08-26
Est. Completion 2012-08-22

What the Registry Record Tells You About NCT00340652

The ClinicalTrials.gov registry entry for NCT00340652 describes a study currently listed as completed, categorized as an unspecified phase. The registered enrollment target is 157 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is National Institute of Environmental Health Sciences (NIEHS), which has 145 total studies on file at ClinicalTrials.gov.

The record links to 0 conditions, and to 0 interventions.

NCT00340652 reports 0 study locations.

Frequently Asked Questions

What is clinical trial NCT00340652 about?

NCT00340652 is a clinical study titled "Effects of Infant Diets on Estrogen Activity and Development". This study, conducted at the Children's Hospital of Boston and the Brigham and Women's 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 t...

What is the current status of trial NCT00340652?

This trial is currently completed. The enrollment target is 157 participants. The study started on 2003-08-26. Estimated completion is 2012-08-22.

Who is sponsoring clinical trial NCT00340652?

This trial is sponsored by National Institute of Environmental Health Sciences (NIEHS), which has 145 total clinical trials registered on ClinicalTrials.gov.

Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

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