Study of Infant Diets on Estrogen Activity and Development

NCT00340665 | Completed

• 2 other identifiers: 99990318403-E-N184
• Study Type: observational
• Target: 239
• Locations: 1 country
• Sites: 2

Brief Summary

This study, conducted at the University of Pennsylvania s Newborn Nursery, the Children s Hospital of Philadelphia, and the Exton Specialty Care Center, will examine how different infant diets may affect estrogen activity in babies. During pregnancy, babies are exposed to the female hormone estrogen from their mother. Estrogen plays a key role in the development of breasts and milk production, as well as the development of the uterus. The effects of these hormones can be seen when babies are examined. 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 has two parts. Part 1 studies the physical development of babies fed different ways. Part 2 studies how hormone levels in babies differ depending on what they are being fed. Babies may participate in one or both parts. Part 1 includes babies 0 to 6 months of age; part 2 includes babies 0 to 12 months of age. In each part of the study, parents may choose to have their babies evaluated from one to four times. Full-term infants (age 37 to 41 weeks gestational age) from birth to 12 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. Male infants must have palpable testes. Infants being fed a diet of breast milk, soy milk, or cow s milk will be included. Study procedures include the following: Part 1

• Feeding history: the parent provides information about the baby s dietary intake since birth.
• Length, weight, and head circumference: the baby s measurements are taken.
• Physical examination: the baby s physical maturity is assessed by examination of the skin, breasts, and external sex organs.
• Breast secretions: the baby s breast buds are gently pressed during the physical examination to look for a milky-white substance that some babies produce during the first year of life. If the substance appears, a specimen will be collected.
• Vaginal cells: for baby girls, the opening of the vaginal area is gently swabbed with a sterile Q-tip to assess the maturity of the vaginal lining. Part 2
• Feeding history and length, weight and head circumference measurements as described above.
• Urine: a urine sample is collected in a cotton diaper or a urine collection bag.
• aliva: a saliva sample is collected by gently swabbing the inside of the baby s mouth 1 hour after a morning feeding to remove any left over milk.
• Hair: a lock of hair, 1/2-inch wide and 1 to 2 inches long is taken from 12-month old babies.
• Blood: some infants have a small blood sample collected by a heel-stick. This study will serve as a basis for a later study about how infant formulas affect infant growth.

Conditions

Infant Formula; Estrogen Activity

Keywords

Soy; Infant Formula; Sexual Development; Hormone; Isoflavones

Eligibility Criteria

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

You may qualify if:

• SEAD 2 and 3
• 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.
• Birth weight between 2501-4499 grams.
• Age 0-6 months for SEAD 2, age 0-12 months for SEAD 3
• For SEAD 3, for 12-months age interval, subjects must not have had first haircut.

You may not qualify if:

• SEAD 2 and 3
• Chromosomal aberrations
• Major malformation
• SEAD 2: Non-palpable testis (males only)
• 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.

Sponsors & Collaborators

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

Study Sites (2)

University of Pennsylvania

Philadelphia, Pennsylvania, 19104-6056, United States

Location

Childrens Hospital, Philadelphia

Philadelphia, Pennsylvania, 19104, 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: May 5, 2003
• Study Completion: August 22, 2012
• Last Updated: November 21, 2019

Record last verified: 2012-08-22

Locations

US (2)