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OpenTrials
Active, Not Recruiting

NCT Number: NCT06393296

A Study of Melatonin Concentration During Lactation

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Age range

18 year and older

Sex eligibility

Female

Study type

Observational

Primary location

Mayo Clinic Health System - Eau Claire

Eau Claire, Wisconsin, 54703, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. Melatonin concentration in breast milk

    Time frame: 14 days postpartum

    Melatonin concentration in breast milk samples, reported in picograms per milliliter (pg/mL)

  2. sIgA concentration in breast milk

    Time frame: 14 days postpartum

    concentration in breast milk samples, reported in picograms per milliliter (pg/mL)

Secondary outcomes

  1. Anxiety Symptoms

    Time frame: 14 days postpartum

    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.

  2. Depression Symptoms

    Time frame: 14 days postpartum

    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.

  3. Fatigue

    Time frame: 14 days postpartum

    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.

  4. Sleep Quality

    Time frame: 14 days postpartum

    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.

Sponsors and collaborators

Lead sponsor

Mayo Clinic

Other

Collaborators

  • Universidade Federal de Goias
  • University of Wisconsin-Eau Claire

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2025
Study completion
2026
First posted
May 1, 2024
Registry last updated
Mar 27, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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