Infant FormulaNCT00340665
Study of Infant Diets on Estrogen Activity and Development
An observational study of Infant Formula and Estrogen Activity, run by National Institute of Environmental Health Sciences (NIEHS) at 2 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages Up to 1 year
- Conditions the study is for
- Infant Formula, Estrogen Activity
- How many people
- 239 participants
- Where
- 2 sitesUnited States
- Study dates
- 5 May 2003to 22 Aug 2012
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 1 year
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
University of Pennsylvania
Philadelphia, Pennsylvania, 19104-6056
Childrens Hospital, Philadelphia
Philadelphia, Pennsylvania, 19104
About this study
Official title: Study of Estrogen Activity & Development (SEAD) SEAD2: Physical Exam and Ballard Markers; Sead 3: Biochemistry
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.
Read more
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.
Read the 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 (diadzein 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 the child. Two cross-sectional pilot study (SEAD 2 and SEAD 3) will be undertaken in order to establish the methods for a future, multi-center study designed to assess the potential effects of soy formula on estrogen activity in infants. Another cross-sectional pilot study (SEAD 1) will be undertaken to evaluate anatomical evidence detected by ultrasound and will be conducted at The Children's Hospital in Boston. Details of the SEAD 1 study will not be presented in this protocol. In the first pilot study (SEAD 2), 84 examinations of full-term infants, ages 0-6 months and on one of three feeding regimens (soy formula, breast milk or cow's milk formula) will be conducted. This study will establish a protocol for examining and sampling methods to be used for a later trial investigating whether exposure to soy estrogen compared to breast milk and non-soy formulas prolongs anatomical evidence of estrogen exposure and response. In addition to the physical examination, vaginal cells will be collected for cytology analysis. Breast nipple secretions, if present, will also be collected and analyzed for protein and sugar levels. In the second pilot study (SEAD 3), 372 evaluations on full-term infants will be conducted in parallel with the first study. SEAD 3 will assess the hormonal and biochemical status of full-term infants age 0-12 months. This study will establish a protocol for sampling methods to be used for collecting urine, saliva, serum, and hair samples. Endogenous hormone levels such as testosterone, estradiol, and isoflavone levels (genestein and diadzein) will be measured in serum and the results will be compared against the non-serum tests (urine, saliva and hair). The purpose of these two pilot studies 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.
- Conditions
- Infant Formula, Estrogen Activity
- Keywords
- Soy, Infant Formula, Sexual Development, Hormone, Isoflavones
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jun 2006 (estimated)
- Study start5 May 2003
- Study completion22 Aug 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Infant FormulaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Enrolment
- 239 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Institute of Environmental Health Sciences (NIEHS)
- Sponsor type
- US National Institutes of Health
- Investigators
- Walter Rogan, M.D., Principal investigator, National Institute of Environmental Health Sciences (NIEHS)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00340665
- Sponsor's protocol ID
- 999903184
- Other IDs
- 03-E-N184
- Status last verified
- 22 Aug 2012
- First submitted
- 19 Jun 2006
- Last updated
- 21 Nov 2019
- Results posted
- No
Publications
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.
PubMed 9848516Cruz 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.
PubMed 8165045Strom 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.
PubMed 11497534
Study at a glance
From the registry record, last updated by the sponsor on 21 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of Estrogen Activity & Development (SEAD) SEAD2: Physical Exam and Ballard Markers; Sead 3: Biochemistry
- ClinicalTrials.gov ID
- NCT00340665
- Acronym / sponsor ID
- 999903184
- Conditions
- Infant Formula, Estrogen Activity
- Keywords
- Soy, Infant Formula, Sexual Development, Hormone, Isoflavones
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 239 participants (actual)
- Lead sponsor
- National Institute of Environmental Health Sciences (NIEHS)US National Institutes of Health
- Study start
- 5 May 2003
- Study completion
- 22 Aug 2012
- First posted
- 21 Jun 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 (diadzein 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 the child. Two cross-sectional pilot study (SEAD 2 and SEAD 3) will be undertaken in order to establish the methods for a future, multi-center study designed to assess the potential effects of soy formula on estrogen activity in infants. Another cross-sectional pilot study (SEAD 1) will be undertaken to evaluate anatomical evidence detected by ultrasound and will be conducted at The Children's Hospital in Boston. Details of the SEAD 1 study will not be presented in this protocol. In the first pilot study (SEAD 2), 84 examinations of full-term infants, ages 0-6 months and on one of three feeding regimens (soy formula, breast milk or cow's milk formula) will be conducted. This study will establish a protocol for examining and sampling methods to be used for a later trial investigating whether exposure to soy estrogen compared to breast milk and non-soy formulas prolongs anatomical evidence of estrogen exposure and response. In addition to the physical examination, vaginal cells will be collected for cytology analysis. Breast nipple secretions, if present, will also be collected and analyzed for protein and sugar levels. In the second pilot study (SEAD 3), 372 evaluations on full-term infants will be conducted in parallel with the first study. SEAD 3 will assess the hormonal and biochemical status of full-term infants age 0-12 months. This study will establish a protocol for sampling methods to be used for collecting urine, saliva, serum, and hair samples. Endogenous hormone levels such as testosterone, estradiol, and isoflavone levels (genestein and diadzein) will be measured in serum and the results will be compared against the non-serum tests (urine, saliva and hair). The purpose of these two pilot studies 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 design
Who may qualify
- Ages
- Up to 1 year
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (6 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Nov 2019.
- Background: PubMed 9848516Setchell 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.
- Background: PubMed 8165045Cruz 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.
- Background: PubMed 11497534Strom 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.
Related trials for Infant Formula
RecruitingObservational study
Improving Nutrition for Babies Born by Caesarean Section
Breastfeeding Mothers of Legal Age, Their Babies Under 6 Months Old Born Vaginally
Active, not recruiting
Growth and Health Outcomes of a New Infant- and follow-on Formula for Healthy Term Infants.
Baby Formula, Growth Equivalence, Neurocognitive Development, Healthy Infants
Recruiting
Extensively Hydrolyzed Formula Growth Monitioring Study (GMS)
Growth
Recruiting
Evaluation of the Nutritional Value of a New Hydrolysed Rice Protein-based Formula
Healthy Term Infants
Not yet recruitingPhase 3
A Clinical Trial on the Effect of Infant Formula Consumption on Growth, Immune Parameters, and Gut Health in Healthy Term Infants
Infant ALL
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Walter Rogan, M.D. principal investigator
National Institute of Environmental Health Sciences (NIEHS)
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Infant Formula and Estrogen Activity, run by National Institute of Environmental Health Sciences (NIEHS) at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Nov 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00340665, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Nov 2019.