Effects of Infant Diets on Estrogen Activity and Development

NCT00340652 | Completed

• 2 other identifiers: 99990328703-E-N287
• Study Type: observational
• Target: 157
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

Hormone

Keywords

Soy; Isoflavones; Infant Formula; Sexual Development; Hormone

Eligibility Criteria

• Age: Up to 1 Year
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.
• Can be categorized into one of the feeding definitions:
• Breastmilk Category:
• hours old (Age-Interval: 1) - Breastmilk exclusively;
• hours - 3 months (Age-Interval: SEAD1 = 2 through 7) - Breastmilk exclusively;
• Greater than 3 months (Age-Interval: SEAD1 = 8 through 19) - Breastmilk exclusively OR Breastmilk and Cow-based formula.
• Restriction: Babies in the Breastmilk category are not allowed to have had any SOY foods including SOY formula and solid foods containing SOY in their lifetime.
• Cow-Based Formula Category:
• hours old (Age-Interval: 1) - Cow-based formula exclusively;
• hours - 3 months (Age-Interval: SEAD1 = 2 through 7) - Cow-based formula exclusively;
• Greater than 3 months (Age-Interval: SEAD1 = 8 through 19) - Cow-based formula exclusively.
• Exception: If a baby was Breastfed in the nursery, the baby must have gone home on Cow-based formula and have been on Cow-based formula exclusively ever since. Such a child cannot participate in the SEAD study until s/he has been exclusively Cow-based formula fed for at last 2 weeks.
• Restriction: Babies in the Cow-based formula category are not allowed to have had any SOY foods including SOY formula and solid foods containing SOY in their lifetime.
• Soy Formula Category:
• hours old (Age-Interval: 1) - Soy formula exclusively;

You may not qualify if:

• Chromosomal anomalies.
• Major malformations.
• Non-palpable testis (males only).
• Presence of an endocrinopathy (i.e., ambiguous genitalia, congenital hypothyroidism).

Sponsors & Collaborators

• National Institute of Environmental Health Sciences (NIEHS): lead

Study Sites (2)

Brigham and Women's Hospital

Boston, Massachusetts, 02115, United States

Location

Childrens Hospital, Boston

Boston, Massachusetts, 02115, United States

Location

Related Publications (3)

• Setchell KD, Zimmer-Nechemias L, Cai J, Heubi JE. Isoflavone content of infant formulas and the metabolic fate of these phytoestrogens in early life. Am J Clin Nutr. 1998 Dec;68(6 Suppl):1453S-1461S. doi: 10.1093/ajcn/68.6.1453S.

  PMID: 9848516 BACKGROUND

• Cruz ML, Wong WW, Mimouni F, Hachey DL, Setchell KD, Klein PD, Tsang RC. Effects of infant nutrition on cholesterol synthesis rates. Pediatr Res. 1994 Feb;35(2):135-40. doi: 10.1203/00006450-199402000-00001.

  PMID: 8165045 BACKGROUND

• Strom BL, Schinnar R, Ziegler EE, Barnhart KT, Sammel MD, Macones GA, Stallings VA, Drulis JM, Nelson SE, Hanson SA. Exposure to soy-based formula in infancy and endocrinological and reproductive outcomes in young adulthood. JAMA. 2001 Aug 15;286(7):807-14. doi: 10.1001/jama.286.7.807.

  PMID: 11497534 BACKGROUND

Study Officials

• Walter Rogan, M.D.

  National Institute of Environmental Health Sciences (NIEHS)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Sponsor Type: NIH

Study Record Dates

• First Submitted: June 19, 2006
• First Posted: June 21, 2006
• Study Start: August 26, 2003
• Study Completion: August 22, 2012
• Last Updated: December 17, 2019

Record last verified: 2012-08-22

Locations

US (2)