Hormone Clinical Trial
Official title:
Study of Estrogen Activity & Development (SEAD) - SEAD 1 Sonography
Verified date | August 22, 2012 |
Source | National Institutes of Health Clinical Center (CC) |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
Status | Completed |
Enrollment | 157 |
Est. completion date | August 22, 2012 |
Est. primary completion date | |
Accepts healthy volunteers | No |
Gender | All |
Age group | N/A to 1 Year |
Eligibility |
- INCLUSION CRITERIA: 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: 0-48 hours old (Age-Interval: 1) - Breastmilk exclusively; 49 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: 0-48 hours old (Age-Interval: 1) - Cow-based formula exclusively; 49 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: 0-48 hours old (Age-Interval: 1) - Soy formula exclusively; 49 hours - 3 months (Age-Interval: SEAD1 = 2 through 7) - Soy formula exclusively; Greater than 3 months (Age-Interval: SEAD1 = 8 through 19) - 2/3 of lifetime on Soy formula exclusively & continuously, and including the two weeks up to the exam. Exception: If a baby was fed something other than Soy formula in the nursery, the baby must have gone home on Soy and been on Soy exclusively ever since. Such a child cannot participate in the SEAD study until s/he has been exclusively Soy-fed for at least 2 weeks. Birth weight between 2501 - 4499 grams. Age 0-12 months for girls and age 0-6 months for boys. EXCLUSION CRITERIA: Chromosomal anomalies. Major malformations. Non-palpable testis (males only). Presence of an endocrinopathy (i.e., ambiguous genitalia, congenital hypothyroidism). |
Country | Name | City | State |
---|---|---|---|
United States | Brigham and Women's Hospital | Boston | Massachusetts |
United States | Childrens Hospital, Boston | Boston | Massachusetts |
Lead Sponsor | Collaborator |
---|---|
National Institute of Environmental Health Sciences (NIEHS) |
United States,
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. — View Citation
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. Review. — View Citation
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. — View Citation
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT04698889 -
Effect of Ingestion of Human, Cow, and Modified-cow Milk, on Glucose and Hormone Responses in Humans.
|
N/A |