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Melatonin Degradation Rate in Human Milk

Melatonin Degradation Rate in Human Milk

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03591341
Enrollment
10
Registered
2018-07-19
Start date
2017-08-01
Completion date
2018-12-31
Last updated
2019-02-01

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

Conditions

Lactation, Preterm Infant

Keywords

melatonin, breast milk

Brief summary

Our long term hypothesis is that giving premature infants breast milk that was pumped during the night and has high concentration of melatonin will improve outcome of several clinical conditions related to premature infants. Prior to testing this, we need to learn the pharmacokinetics of melatonin in vitro. In this preliminary research we would like to check the levels of melatonin in breast milk pumped during the night, and evaluate the rate of degradation of the melatonin to determine the half life of melatonin in pumped breast milk (in vitro).

Detailed description

The study includes 10 nursing women. Each woman will bring a frozen 5 ml sample of breast milk that was pumped at 03:00 AM. The samples will be collected at the NICU department of Carmel Medical Center and will be stored at deep freeze (-20°C). The samples will be numerically coded and will be kept anonimously. After defrosting the samples, melatonin concentration will be checked in the hospital laboratory every hour, for 4 hours. If meltonin levels will be detectable after 4 hours, continous measurements will be done at 8 hours and at 12 hours after defrosting. The samples will be tested with IBL Melatonin ELISA kit. For control we will use breast milk that was pumped at 10:00 am (when melatonin excretion is minimal). At the end of the analysis the samples will be thrown away.

Interventions

DIAGNOSTIC_TESTmelatonin level in pumped breast milk

diagnostic test of melatonin level in pumped breast milk

Sponsors

Carmel Medical Center
Lead SponsorOTHER

Study design

Observational model
OTHER
Time perspective
PROSPECTIVE

Eligibility

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

Inclusion criteria

1. Women that are breast feeding and will pump and freeze a milk sample at 03:00 AM 2. Women at least one week after delivery

Exclusion criteria

1. A sample that will not be freezed right after the pump 2. Women that are taking hypnotic drugs 3. Women that are taking melatonin

Design outcomes

Primary

MeasureTime frameDescription
melatonin stability in human milk24 hoursmelatonin levels in human milk samples are checked every hour after defrost

Countries

Israel

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026