A Study of Melatonin Concentration During Lactation

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Breastfeeding

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 Type: Observational
• Enrollment (Estimated): 120

Contacts and Locations

Study Locations

• United States
  • Wisconsin
    • Eau Claire, Wisconsin, United States, 54703
      • Mayo Clinic Health System - Eau Claire

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

• Sampling Method: Probability Sample

Study Population

New mothers receiving care at Mayo Clinic Health System in Eau Claire, Wisconsin.

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
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 the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Melatonin concentration in breast milk	Melatonin concentration in breast milk samples, reported in picograms per milliliter (pg/mL)	14 days postpartum
sIgA concentration in breast milk	concentration in breast milk samples, reported in picograms per milliliter (pg/mL)	14 days postpartum

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	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.	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.	14 days postpartum

Collaborators and Investigators

• Sponsor: Mayo Clinic
• Collaborators: Universidade Federal de Goias; University of Wisconsin, Eau Claire
• Investigators: Principal Investigator: Ganesh Namachivayam, MD, MPH, Mayo Clinic

Publications and helpful links

Helpful Links

• Mayo Clinic Clinical Trials
• Mayo Clinic Website

Study record dates

Study Major Dates

• Study Start (Actual): April 17, 2024
• Primary Completion (Actual): October 24, 2025
• Study Completion (Estimated): June 30, 2026

Study Registration Dates

• First Submitted: April 26, 2024
• First Submitted That Met QC Criteria: April 26, 2024
• First Posted (Actual): May 1, 2024

Study Record Updates

• Last Update Posted (Actual): March 27, 2026
• Last Update Submitted That Met QC Criteria: March 23, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Behavior; Feeding Behavior; Breast Feeding
• Other Study ID Numbers: 23-006493

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No