BreastfeedingNCT06393296
A Study of Melatonin Concentration During Lactation
An observational study of Breastfeeding, run by Mayo Clinic at 1 site in United States.
Trial summary
This research is being done to understand better how a mother's emotional well-being and lifestyle, such as her levels of stress, fatigue, depression, anxiety, sleep quality, and eating habits, might affect the levels of melatonin and sIgA in her breast milk. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Breastfeeding
- How many people
- 88 participants
- Where
- 1 siteUnited States
- Study dates
- 17 Apr 2024to 18 Jun 2026
- 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 18 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Study population: New mothers receiving care at Mayo Clinic Health System in Eau Claire, Wisconsin.
Who may be able to join
- Possess a refrigerator with a freezer or a standalone freezer for sample storage at home.
- Ability to be contacted by telephone.
- Having internet access at home.
- Being in the immediate (0-14 days) postpartum period.
- Currently breastfeeding or planning to breastfeed, regardless of the type.
Who cannot join
- Newborns with congenital malformations.
- Newborns with birth weights less than 2,500g or greater than 4,000g.
- Gestational age less than 37 completed weeks or greater than 42 completed weeks.
- Mothers hospitalized in an intensive care unit (ICU).
- Newborns hospitalized in the neonatal intensive care unit (NICU) or special care nursery (SCN).
- Mothers using sleep aids (e.g., Benadryl, Unisom, Melatonin, Valerian).
- Mothers currently being treated for pharmacologically treated mood and sleep disorders.
- Mothers with acute infections longer than 7 days postpartum. Mothers will be withdrawn from study if antibiotics are taken between 7 and 14 days postpartum.
Trial locations and contacts
1 site in 1 country.
United States1 site
Mayo Clinic Health System - Eau Claire
Eau Claire, Wisconsin, 54703
About this study
Official title: Melatonin and Secretory Immunoglobulin A (sIgA) Concentration During Lactation, Maternal Determinants and Repercussions
This research is being done to understand better how a mother's emotional well-being and lifestyle, such as her levels of stress, fatigue, depression, anxiety, sleep quality, and eating habits, might affect the levels of melatonin and sIgA in her breast milk.
Read the detailed description
This study aims to learn more about promoting mothers' and babies' health by studying various maternal factors. Gaining a better understanding of the connections between a mother's emotional and physical state and the quality of her breast milk could lead to new recommendations and support strategies to improve the mother's well-being.
Participants will be involved in the study during the immediate postpartum period. They will be asked to provide a 5mL sample of breast milk on day 14 postpartum between 6am and 9am. Participants will be asked to use an orange ambient light during nighttime infant care from the time they come home from the hospital up until the time of breastmilk collection to avoid harsh lighting while providing care for their baby, which may affect melatonin levels.
In addition to breast milk collection, participants will complete a series of questionnaires related to their emotion well-being and lifestyle. These questionnaires will help the research team understand how factors like stress, fatigue, depression, anxiety, sleep, and dietary patterns may be associated with melatonin and sIgA levels in breast milk. Information regarding medications and gestational age of the newborn will be collected from medical records to further assist in data analysis.
- Conditions
- Breastfeeding
- Medical subject headings
- Breast Feeding
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 |
|---|---|---|
| Breasting Feeding Mothers | New mothers in the immediate postpartum period and breastfeeding their newborn will be asked to collect a sample of breast milk at 14 days postpartum between 6 am and 9 am. In addition to providing a breast milk sample, they will complete a series of questionnaires related to their emotional well-being and lifestyles. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Melatonin concentration in breast milk
Melatonin concentration in breast milk samples, reported in picograms per milliliter (pg/mL)
Measured: 14 days postpartum
sIgA concentration in breast milk
concentration in breast milk samples, reported in picograms per milliliter (pg/mL)
Measured: 14 days postpartum
Secondary outcomes (4)
Anxiety Symptoms
Measured using the 14-item Depression, Anxiety and Stress Scale that assesses negative emotional states. Possible total scores range from 0 to 42, with higher scores indicating more negative emotional state and worse outcome.
Measured: 14 days postpartum
Depression Symptoms
Measured using the 10-item Edinburgh Depression Scale (EDS) that assesses depressive symptoms. Possible total scores range from 0 to 30, with higher scores indicating more depressive symptoms and a worse outcome.
Measured: 14 days postpartum
Fatigue
Measured using the 10-item Fatigue Assessment Scale that assesses symptoms of chronic fatigue. Possible total scores range from 10 to 50. A total FAS score < 22 indicates no fatigue, a score ≥ 22 indicates fatigue.
Measured: 14 days postpartum
Sleep Quality
Measured using the The Pittsburgh Sleep Quality Index that assesses the severity of sleep disturbances. Possible scores range from 0 to 21 with higher scores indicating a worse outcome/more severe symptoms of sleep disturbance.
Measured: 14 days postpartum
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 May 2024
- Study start17 Apr 2024
- Primary completion24 Oct 2025
- Study completion18 Jun 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for BreastfeedingStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe sponsor's other registered studies.
- 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
- Cross-sectional
- Enrolment
- 88 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Collaborators
- Universidade Federal de Goias, University of Wisconsin-Eau Claire
- Responsible party
- Principal investigator, Ganesh Namachivayam, Mayo Clinic
- Investigators
- Ganesh Namachivayam, MD, MPH, Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06393296
- Sponsor's protocol ID
- 23-006493
- Status last verified
- Jul 2026
- First submitted
- 26 Apr 2024
- Last updated
- 12 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Melatonin and Secretory Immunoglobulin A (sIgA) Concentration During Lactation, Maternal Determinants and Repercussions
- ClinicalTrials.gov ID
- NCT06393296
- Acronym / sponsor ID
- 23-006493
- Conditions
- Breastfeeding
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 88 participants (actual)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Collaborators
- Universidade Federal de Goias, University of Wisconsin-Eau Claire
- Study start
- 17 Apr 2024 (actual)
- Primary completion
- 24 Oct 2025 (actual)
- Study completion
- 18 Jun 2026 (actual)
- First posted
- 1 May 2024 (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.
This research is being done to understand better how a mother's emotional well-being and lifestyle, such as her levels of stress, fatigue, depression, anxiety, sleep quality, and eating habits, might affect the levels of melatonin and sIgA in her breast milk.
Detailed description
This study aims to learn more about promoting mothers' and babies' health by studying various maternal factors. Gaining a better understanding of the connections between a mother's emotional and physical state and the quality of her breast milk could lead to new recommendations and support strategies to improve the mother's well-being.
Participants will be involved in the study during the immediate postpartum period. They will be asked to provide a 5mL sample of breast milk on day 14 postpartum between 6am and 9am. Participants will be asked to use an orange ambient light during nighttime infant care from the time they come home from the hospital up until the time of breastmilk collection to avoid harsh lighting while providing care for their baby, which may affect melatonin levels.
In addition to breast milk collection, participants will complete a series of questionnaires related to their emotion well-being and lifestyle. These questionnaires will help the research team understand how factors like stress, fatigue, depression, anxiety, sleep, and dietary patterns may be associated with melatonin and sIgA levels in breast milk. Information regarding medications and gestational age of the newborn will be collected from medical records to further assist in data analysis.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Breasting Feeding Mothers | – | –New mothers in the immediate postpartum period and breastfeeding their newborn will be asked to collect a sample of breast milk at 14 days postpartum between 6 am and 9 am. In addition to providing a breast milk sample, they will complete a series of questionnaires related to their emotional well-being and lifestyles. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- New mothers receiving care at Mayo Clinic Health System in Eau Claire, Wisconsin.
Key inclusion criteria (5 listed)
- Possess a refrigerator with a freezer or a standalone freezer for sample storage at home.
- Ability to be contacted by telephone.
- Having internet access at home.
- Being in the immediate (0-14 days) postpartum period.
- Currently breastfeeding or planning to breastfeed, regardless of the type.
Key exclusion criteria (8 listed)
- Newborns with congenital malformations.
- Newborns with birth weights less than 2,500g or greater than 4,000g.
- Gestational age less than 37 completed weeks or greater than 42 completed weeks.
- Mothers hospitalized in an intensive care unit (ICU).
- Newborns hospitalized in the neonatal intensive care unit (NICU) or special care nursery (SCN).
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
Melatonin concentration in breast milk
Time frame: 14 days postpartum
Melatonin concentration in breast milk samples, reported in picograms per milliliter (pg/mL)
sIgA concentration in breast milk
Time frame: 14 days postpartum
concentration in breast milk samples, reported in picograms per milliliter (pg/mL)
4 secondary outcomes
Anxiety Symptoms
Time frame: 14 days postpartum
Depression Symptoms
Time frame: 14 days postpartum
Fatigue
Time frame: 14 days postpartum
Sleep Quality
Time frame: 14 days postpartum
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 12 Aug 2026.
- Mayo Clinic Clinical TrialsLink provided by the sponsor.
- Individual participant dataSharing planned: No
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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.
Ganesh Namachivayam, MD, MPH principal investigator
Mayo Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Breastfeeding, run by Mayo Clinic at 1 site 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 5 inclusion and 8 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 12 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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.
What does the primary outcome measure?
Melatonin concentration in breast milk (time frame: 14 days postpartum). The study lists 2 primary outcomes in all. 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 12 Aug 2026.