A Study of Melatonin Concentration During Lactation

Running, not enrolling

Conditions studied: Breastfeeding

In brief

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.

Key facts

Study ID

NCT06393296

Run by

Mayo Clinic

People needed

120

Starts

2024-04-17

Expected to finish

2026-06-30

Last updated by the study team

2026-03-27

Who can join

Age: 18 and older. Sex: female. Healthy volunteers: accepted.

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 Mothers will be withdrawn from study if antibiotics are taken between 7 and 14 days postpartum.

Where it is running

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

Full record on ClinicalTrials.gov

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