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

NCT06382610 | Completed

• 1 other identifier: 2024-002
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Sleep

Keywords

melatonin; transdermal; oral; pharmacokinetics

Outcome Measures

Primary Outcomes (1)

• Salivary melatonin level

  assessed via ELISA

  from immediately prior to administration to 48 hours post administration

Secondary Outcomes (1)

• Side effects

  from immediately prior to administration to 48 hours post administration

Study Arms (3)

Oral tablet

ACTIVE COMPARATOR

3 mg Tablets (Nature Made). Participants will need to fast for 2 hours prior to consumption and 2 hours after consumption.

Dietary Supplement: Melatonin

Lotion

EXPERIMENTAL

Dr. Teal's Sleep Lotion with Melatonin, Lavender, and Chamomile. 3 g lotion applied to one arm (without washing for at least 4 hours).

Dietary Supplement: Melatonin

Bubble bath

EXPERIMENTAL

Dr. Teal's Sleep Bath with Melatonin, Lavender, and Chamomile. 40L warm tap water maintained between 36.5 - 40 degrees C (98 - 104 degrees F) and 2 ml bubble bath. Participants will soak their feet and legs in the cooler for 15 minutes and then dry off (without rinsing or washing for at least 4 hours).

Dietary Supplement: Melatonin

Interventions

Melatonin DIETARY_SUPPLEMENT

Melatonin will be administered in three different forms

Bubble bath; Lotion; Oral tablet

Eligibility Criteria

• Age: 18 Years - 22 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• University of Redlands student

You may not qualify if:

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

Sponsors & Collaborators

• University of Redlands: lead

Study Sites (1)

University of Redlands

Redlands, California, 92373, United States

Location

MeSH Terms

Interventions

Melatonin

Intervention Hierarchy (Ancestors)

Tryptamines; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists

Study Officials

• Lisa E Olson, Ph.D.

  University of Redlands

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Repeated measures crossover trial

Study Record Dates

• First Submitted: April 19, 2024
• First Posted: April 24, 2024
• Study Start: May 19, 2024
• Primary Completion: July 31, 2024
• Study Completion: July 31, 2024
• Last Updated: October 8, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF
• Time Frame: After relevant publication. Data will remain at the National Sleep Research Resource following their policy for keeping records.
• Access Criteria: According to the National Sleep Research Resource

Locations

US (1)