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OpenTrials
Completed

NCT Number: NCT06382610

Pharmacokinetics of Melatonin Administered in Oral, Lotion, and Bubble Bath Formulations

Melatonin is a hormone that promotes sleep that is available without a prescription in the United States. In addition to oral supplements, melatonin can be purchased in the form of lotions and bubble baths with unknown dosage and no frequency or age recommendations. In this study, researchers will examine how quickly melatonin in lotion and bubble bath is absorbed compared to oral tablets, as well as how long the melatonin lasts in the body.

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Key information

Conditions

Age range

18 year–22 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Redlands

Redlands, California, 92373, United States

About this study

Melatonin is a hormone that promotes sleep that is available without a prescription in the United States. In addition to oral supplements, melatonin can be purchased in the form of lotions and bubble baths with unknown dosage and no frequency or age recommendations. A previous study (unpublished) has shown that a small amount of an over-the-counter lotion increases salivary melatonin levels by up to 1000 fold, a startling amount. Researchers will characterize the time course of the absorption and metabolism of lotion- and bubble bath-based melatonin compared to oral tablets in healthy 18-22 year olds.

The peak level, time to peak level and half-life of melatonin will be compared between the administration routes using a within-person (repeated measures) design and saliva sampling over 48 hours. Participants can choose specific days to participate within a one-month window, with a maximum of four sampling periods. All participants will collect control saliva samples (no melatonin treatment) one night at 10 PM and 4 AM. Participants will be asked to have two treatments 1) oral melatonin and 2) either lotion melatonin or bubble-bath melatonin. Participants can indicate if they have a preference for lotion vs. bubble bath or if they are willing to undergo both lotion and bubble bath treatments (adding a fourth sampling period). Order will be randomized.

For the treatments, saliva sampling times are as follows: Prior to melatonin administration (10 AM), then 15 min, 30 min, 45 min, 60 min, 90 min, 2 hours, 3 hours, 4 hours, 6 hours, 8 hours, 12 hours (10 PM), 18 hours (4 AM), 24 hours, 36 hours, and 48 hours after administration. Samples will be frozen at the participant's home until returned to the researchers at a later date. Melatonin in saliva samples will be quantitated via Enzyme Linked Immunosorbent Assay.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • University of Redlands student

Exclusion criteria

  • Allergies or sensitivities to scented lotions or bath products
  • Pregnancy

Treatment and study plan

melatonin

Dietary Supplement

Melatonin will be administered in three different forms

Primary outcomes

  1. Salivary melatonin level

    Time frame: from immediately prior to administration to 48 hours post administration

    assessed via ELISA

Secondary outcomes

  1. Side effects

    Time frame: from immediately prior to administration to 48 hours post administration

    Frequency of headache, drowsiness, dizziness, skin irritation, vivid dreams, and nightmares

Sponsors and collaborators

Lead sponsor

University of Redlands

Other

Registry information

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
Apr 24, 2024
Registry last updated
Oct 8, 2024

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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