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A Study of Melatonin Concentration During Lactation

Melatonin and Secretory Immunoglobulin A (sIgA) Concentration During Lactation, Maternal Determinants and Repercussions

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06393296
Enrollment
88
Registered
2024-05-01
Start date
2024-04-17
Completion date
2026-06-18
Last updated
2026-08-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Breastfeeding

Brief 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.

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.

Interventions

None listed

Sponsors

Mayo Clinic
Lead SponsorOTHER
Universidade Federal de Goias
CollaboratorOTHER
University of Wisconsin-Eau Claire
CollaboratorOTHER

Study design

Observational model
COHORT
Time perspective
CROSS_SECTIONAL

Eligibility

Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
Yes

Inclusion criteria

* 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.

Exclusion criteria

* 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.

Design outcomes

Primary

MeasureTime frameDescription
Melatonin concentration in breast milk14 days postpartumMelatonin concentration in breast milk samples, reported in picograms per milliliter (pg/mL)
sIgA concentration in breast milk14 days postpartumconcentration in breast milk samples, reported in picograms per milliliter (pg/mL)

Secondary

MeasureTime frameDescription
Anxiety Symptoms14 days postpartumMeasured 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.
Depression Symptoms14 days postpartumMeasured 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.
Fatigue14 days postpartumMeasured 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.
Sleep Quality14 days postpartumMeasured 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.

Countries

United States

Contacts

PRINCIPAL_INVESTIGATORGanesh Namachivayam, MD, MPH

Mayo Clinic

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Aug 13, 2026