Ignite Creation Date:
2024-05-06 @ 8:27 PM
Last Modification Date:
2024-10-26 @ 3:27 PM
Study NCT ID:
NCT06382610
Status:
COMPLETED
Last Update Posted:
2024-04-24
First Post:
2024-04-19
Brief Title:
Pharmacokinetics of Melatonin Administered in Oral Lotion and Bubble Bath Formulations
Sponsor:
University of Redlands
Organization:
University of Redlands
Study Overview
Official Title:
Pharmacokinetics of Melatonin Administered in Oral Lotion and Bubble Bath Formulations
Status:
COMPLETED
Status Verified Date:
2024-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
Detailed 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in the form of lotions and bubble baths with unknown dosage and no frequency or age recommendations A previous study unpublished has shown that a small amount of an over-the-counter lotion increases salivary melatonin levels by up to 1000 fold a startling amount Researchers will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 participants home until returned to the researchers at a later date Melatonin in saliva samples will be quantitated via Enzyme Linked Immunosorbent Assay
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 participants home until returned to the researchers at a later date Melatonin in saliva samples will be quantitated via Enzyme Linked Immunosorbent Assay
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None