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

Sleep Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06382610
• Other study ID #: 2024-002
• Status: Not yet recruiting
• Phase: N/A
• Start date: May 10, 2024
• Est. completion date: December 15, 2024

Study information

• Verified date: April 2024
• Source: University of Redlands
• Contact: Steven E Moore, Ph.D.
• Phone: 909-748-8687
• Email: steven_moore[@]redlands.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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 A previous study (unpublished) has shown that a small amount of an over-the-counter lotion increases salivary melatonin levels by up to 1000 fold, a startling amount.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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 10
• Est. completion date: December 15, 2024
• Est. primary completion date: December 15, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 22 Years

Eligibility

Inclusion Criteria:

• University of Redlands student

Exclusion Criteria:

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

Related Conditions & MeSH terms

• Sleep

Intervention

Dietary Supplement:
• Melatonin
Melatonin will be administered in three different forms

Locations

Country	Name	City	State
United States	University of Redlands	Redlands	California

Sponsors (1)

Lead Sponsor	Collaborator
University of Redlands

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Salivary melatonin level	assessed via ELISA	from immediately prior to administration to 48 hours post administration
Secondary	Side effects	Frequency of headache, drowsiness, dizziness, skin irritation, vivid dreams, and nightmares	from immediately prior to administration to 48 hours post administration