A Study of Melatonin Concentration During Lactation

NCT06393296 | Active Not Recruiting

• 1 other identifier: 23-006493
• Study Type: observational
• Target: 120
• Locations: 1 country
• Sites: 1

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.

Conditions

Breastfeeding

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (4)

• Anxiety Symptoms

  14 days postpartum

• Depression Symptoms

  14 days postpartum

• Fatigue

  14 days postpartum

• Sleep Quality

  14 days postpartum

Study Arms (1)

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

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

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Mayo Clinic: lead
• Universidade Federal de Goias: collaborator
• University of Wisconsin, Eau Claire: collaborator

Study Sites (1)

Mayo Clinic Health System - Eau Claire

Eau Claire, Wisconsin, 54703, United States

Location

Related Links

• Mayo Clinic Website
• Mayo Clinic Clinical Trials

Biospecimen

Retention: SAMPLES WITH DNA

Breast milk.

MeSH Terms

Conditions

Breast Feeding

Condition Hierarchy (Ancestors)

Feeding Behavior; Behavior

Study Officials

• Ganesh Namachivayam, MD, MPH

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: April 26, 2024
• First Posted: May 1, 2024
• Study Start: April 17, 2024
• Primary Completion: October 24, 2025
• Study Completion (Estimated): June 30, 2026
• Last Updated: March 27, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)