PubertyNCT05463120
Minipuberty of Infancy and the Timing of Pubertal Development in Adolescence: a Follow-up of the Infant Feeding and Early Development (IFED) Cohort
An observational study of Puberty, run by National Institute of Environmental Health Sciences (NIEHS) at 2 sites in United States.
Trial summary
Background: Earlier puberty is associated with adverse health throughout a person s life. The average age when puberty begins has been declining over the past decades in girls, and may also be declining in boys. The reasons for this shift are unknown. Read more about this study
- Who is it for?
- Ages 8 to 100 yearsHealthy volunteers can take part
- Conditions the study is for
- Puberty
- How many people
- 566 participants
- Where
- 2 sitesUnited States
- Study dates
- 10 Oct 2022to 1 Mar 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 8 to 100 years
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: The eligible population includes 283 children (136 girls, 147 boys), and their mothers or other parent/guardian, who completed the original IFED study, conducted when the children where 0-9 months of age (2010-2014).
Who may be able to join
- In order to be eligible to participate in this study, an individual must meet all of the following criteria:
- Completion of the original IFED study, defined as participants who did not withdraw from the study or were not withdrawn by the investigator prior to the end of original follow-up (up to 7 months in males and 9 months in females) and who provided at least the minimum number of blood samples (3 for boys, 4 for girls) across the original study period (N=283 eligible families).
- Ability of subject and mother to understand and the willingness to review informed assent and consent documents, respectively, and indicate agreement to participate.
Who cannot join
- We will not exclude any participants that meet the inclusion criteria from participating in the study overall or in any of the study procedures. We will collect information, via maternal report and linked medical records, on relevant medical diagnoses and the use of medications that may affect hormone levels, growth, and pubertal development. We may exclude participants with reported conditions or medication use (listed below) from analyses of some study aims or in sensitivity analyses.
- Diagnoses/conditions:
- Central or peripheral precocious puberty
- Delayed puberty
- Growth hormone deficiency
- Stunted or delayed growth
Show all 16Show fewer
- Idiopathic short stature
- Hypopituitarism
- Thyroid conditions, such as hyperthyroid, hypothyroid, Graves disease, Hashimoto's thyroiditis
- Genetic conditions, such as Prader-Willi syndrome, Turner syndrome, and Noonan syndrome
- Medications:
- Gonadotropin-Releasing Hormone Agonists (e.g., leuprolide acetate (Lupron Depot), triptorelin (Triptodur), histrelin implant (Supprelin LA))
- Hormone therapy (e.g., testosterone, estrogen)
- Synthetic human growth hormone or IGF-1
- Synthetic thyroid hormone (e.g., levothyroxine)
- Anti-thyroid medications (e.g., methimazole, propylthiouracil) or radioactive iodine treatment
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States2 sites
National Institute of Environmental Health Sciences (NIEHS)
Bethesda, Maryland, 20892
Social & Scientific Systems
Durham, North Carolina, 27703
About this study
Background:
Earlier puberty is associated with adverse health throughout a person s life. The average age when puberty begins has been declining over the past decades in girls, and may also be declining in boys. The reasons for this shift are unknown.
Read more
Objective:
To determine whether internal (physical, hormonal) or external (feeding, environment) factors during infancy affect growth and the timing of puberty.
Eligibility:
Mothers (or other parent/guardian) and their children who completed the Infant Feeding and Early Development (IFED) study.
Design:
Participants will complete all activities at home for this natural history study.
Participant mothers will fill out two 15-minute questionnaires:
- One will be about themselves. They will answer questions about their body size in childhood, their puberty, and their pregnancies.
- The other will be about their child. They will answer questions about their child s puberty and lifestyle.
Child participants will fill out a questionnaire about their body changes during puberty. This will take 10 minutes.
Participants will be sent an electronic scale and a measuring tape. They will measure the child s weight, height, and waist and hip circumference. These numbers can be submitted online or by phone or mail.
Participants will receive a kit for collecting urine samples. Child participants will collect urine in a cup upon waking 4 days in a row. A special filter card is dipped in the cup then hung to dry. The dried cards will be mailed back.
Participants will allow researchers to access their child s medical records.
Questionnaires and body measurements will be repeated after 6 and 12 months. Urine sample collection will be repeated after 12 months.
All questionnaires can be done either online, by mail, or by phone on request.
Read the detailed description
Study Description: Our overarching hypothesis is that endogenous and exogenous factors related to hypothalamic-pituitary-gonadal (HPG) axis activity during minipuberty of infancy are associated with childhood growth, the timing of pubertal development, and HPG axis activity in adolescence. To examine this hypothesis, we will conduct an observational follow-up study of children previously enrolled as infants in the Infant Feeding and Early Development (IFED) cohort. This follow-up study will be conducted remotely with data collection via email/online, mail and telephone by contractors at DLH, working on behalf of NIEHS.
Objectives: Primary Objective: To assess whether endogenous (e.g. hormone concentrations and size of hormone-sensitive organs) and exogenous (e.g. infant feeding method, exposure to endocrine disrupting chemicals) factors during minipuberty of infancy are related to a) growth, b) timing of pubertal development, and c) HPG axis activity in adolescence.
Endpoints: Primary Endpoints:
- Height, weight and body mass index (BMI)
- Onset of breast, pubic hair and/or genital development
- Urinary metabolites of reproductive hormones (e.g. gonadotropins and sex steroids)
- Conditions
- Puberty
- Keywords
- Childhood, Growth, Adolescence, Hormone, Natural History
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| IFED-2 | Children who participated in the IFED study as infants (2010-2014) and a parent/guardian will be enrolled in this follow-up study in childhood and followed for at least one year. |
What is being measured
The primary outcome is the main question the study is designed to answer.
To assess whether growth, timing of pubertal development, and hypothalamic-pituitary-gonadal (HPG) axis activity in childhood and adolescence are related to endogenous and exogenous endocrine-related factors during minipuberty of infancy.
1)Growth in height, weight and body mass index 2)Onset of pubic hair development, breast development (females), genital development (males) 3)Urinary concentrations of reproductive hormone metabolites (e.g., gonadotropins, estradiol, testosterone)
Measured: Various time points in childhood/adolescence (study enrollment, 6-month and 12-month follow-up visits currently planned). We anticipate that children will be 8-12 years of age at enrollment (2022) and followed prospectively.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jul 2022
- Study start10 Oct 2022
- Primary completion1 Mar 2027 (estimated)
- Study completion1 Mar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PubertyStudies 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
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 566 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Institute of Environmental Health Sciences (NIEHS)
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
- Investigators
- Dale P Sandler, Ph.D., Principal investigator, National Institute of Environmental Health Sciences (NIEHS)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05463120
- Sponsor's protocol ID
- 10000945
- Other IDs
- 000945-E
- Status last verified
- 22 Sep 2026
- First submitted
- 15 Jul 2022
- Last updated
- 24 Sep 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Individual participant data may be shared with other researchers upon request. Plans for sharing data if requested are included in the study protocol.
Study at a glance
From the registry record, last updated by the sponsor on 24 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Minipuberty of Infancy and the Timing of Pubertal Development in Adolescence: a Follow-up of the Infant Feeding and Early Development (IFED) Cohort
- ClinicalTrials.gov ID
- NCT05463120
- Acronym / sponsor ID
- 10000945
- Conditions
- Puberty
- Keywords
- Childhood, Growth, Adolescence, Hormone, Natural History
- Study type
- Observational
- Recruitment status
- Enrolling by invitation
- Enrolment
- 566 participants (estimated)
- Lead sponsor
- National Institute of Environmental Health Sciences (NIEHS)US National Institutes of Health
- Study start
- 10 Oct 2022 (actual)
- Primary completion
- 1 Mar 2027 (estimated)
- Study completion
- 1 Mar 2027 (estimated)
- First posted
- 18 Jul 2022 (actual)
- 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.
Background:
Earlier puberty is associated with adverse health throughout a person s life. The average age when puberty begins has been declining over the past decades in girls, and may also be declining in boys. The reasons for this shift are unknown.
Objective:
To determine whether internal (physical, hormonal) or external (feeding, environment) factors during infancy affect growth and the timing of puberty.
Eligibility:
Mothers (or other parent/guardian) and their children who completed the Infant Feeding and Early Development (IFED) study.
Design:
Participants will complete all activities at home for this natural history study.
Participant mothers will fill out two 15-minute questionnaires:
- One will be about themselves. They will answer questions about their body size in childhood, their puberty, and their pregnancies.
- The other will be about their child. They will answer questions about their child s puberty and lifestyle.
Child participants will fill out a questionnaire about their body changes during puberty. This will take 10 minutes.
Participants will be sent an electronic scale and a measuring tape. They will measure the child s weight, height, and waist and hip circumference. These numbers can be submitted online or by phone or mail.
Participants will receive a kit for collecting urine samples. Child participants will collect urine in a cup upon waking 4 days in a row. A special filter card is dipped in the cup then hung to dry. The dried cards will be mailed back.
Participants will allow researchers to access their child s medical records.
Questionnaires and body measurements will be repeated after 6 and 12 months. Urine sample collection will be repeated after 12 months.
All questionnaires can be done either online, by mail, or by phone on request.
Detailed description
Study Description: Our overarching hypothesis is that endogenous and exogenous factors related to hypothalamic-pituitary-gonadal (HPG) axis activity during minipuberty of infancy are associated with childhood growth, the timing of pubertal development, and HPG axis activity in adolescence. To examine this hypothesis, we will conduct an observational follow-up study of children previously enrolled as infants in the Infant Feeding and Early Development (IFED) cohort. This follow-up study will be conducted remotely with data collection via email/online, mail and telephone by contractors at DLH, working on behalf of NIEHS.
Objectives: Primary Objective: To assess whether endogenous (e.g. hormone concentrations and size of hormone-sensitive organs) and exogenous (e.g. infant feeding method, exposure to endocrine disrupting chemicals) factors during minipuberty of infancy are related to a) growth, b) timing of pubertal development, and c) HPG axis activity in adolescence.
Endpoints: Primary Endpoints:
- Height, weight and body mass index (BMI)
- Onset of breast, pubic hair and/or genital development
- Urinary metabolites of reproductive hormones (e.g. gonadotropins and sex steroids)
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| IFED-2 | – | –Children who participated in the IFED study as infants (2010-2014) and a parent/guardian will be enrolled in this follow-up study in childhood and followed for at least one year. |
Who may qualify
- Ages
- 8 to 100 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- The eligible population includes 283 children (136 girls, 147 boys), and their mothers or other parent/guardian, who completed the original IFED study, conducted when the children where 0-9 months of age (2010-2014).
Key inclusion criteria (3 listed)
- In order to be eligible to participate in this study, an individual must meet all of the following criteria:
- Completion of the original IFED study, defined as participants who did not withdraw from the study or were not withdrawn by the investigator prior to the end of original follow-up (up to 7 months in males and 9 months in females) and who provided at least the minimum number of blood samples (3 for boys, 4 for girls) across the original study period (N=283 eligible families).
- Ability of subject and mother to understand and the willingness to review informed assent and consent documents, respectively, and indicate agreement to participate.
Key exclusion criteria (16 listed)
- We will not exclude any participants that meet the inclusion criteria from participating in the study overall or in any of the study procedures. We will collect information, via maternal report and linked medical records, on relevant medical diagnoses and the use of medications that may affect hormone levels, growth, and pubertal development. We may exclude participants with reported conditions or medication use (listed below) from analyses of some study aims or in sensitivity analyses.
- Central or peripheral precocious puberty
- Delayed puberty
- Growth hormone deficiency
- Stunted or delayed growth
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
To assess whether growth, timing of pubertal development, and hypothalamic-pituitary-gonadal (HPG) axis activity in childhood and adolescence are related to endogenous and exogenous endocrine-related factors during minipuberty of infancy.
Time frame: Various time points in childhood/adolescence (study enrollment, 6-month and 12-month follow-up visits currently planned). We anticipate that children will be 8-12 years of age at enrollment (2022) and followed prospectively.
1)Growth in height, weight and body mass index 2)Onset of pubic hair development, breast development (females), genital development (males) 3)Urinary concentrations of reproductive hormone metabolites (e.g., gonadotropins, estradiol, testosterone)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Sep 2026.
- Individual participant dataSharing planned: Undecided. Individual participant data may be shared with other researchers upon request. Plans for sharing data if requested are included in the study protocol.
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Puberty Changes
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.
Dale P Sandler, Ph.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 Puberty, 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 3 inclusion and 16 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: enrolling by invitation, as of the sponsor's last update on 24 Sep 2026. 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?
This study is still under way. Results are not available in the source record yet.
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.
What does the primary outcome measure?
To assess whether growth, timing of pubertal development, and hypothalamic-pituitary-gonadal (HPG) axis activity in childhood and adolescence are related to endogenous and exogenous endocrine-related factors during minipuberty of infancy. (time frame: Various time points in childhood/adolescence (study enrollment, 6-month and 12-month follow-up visits currently planned). We anticipate that children will be 8-12 years of age at enrollment (2022) and followed prospectively.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 24 Sep 2026.