NCT03746821

Biotin Sample Collection Study

Biotin Urine Collection Study

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 12 (actual)
• Sponsor: SPD Development Company Limited · Industry
• Sex: Female
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

Summary

This protocol has been designed for a collection of urine samples from volunteers who will be given high dose biotin supplements over a period of 5 days, in order to provide a research sample bank to examine for biotin excretion rates

Detailed description

This is a sample collection study from a minimum of 10 volunteers who will be required to take a Biotin supplement daily for a period of 5 days. Each volunteer will be asked to read the volunteer information sheet and if they wish to participate in the study, the study admission form will be completed and the volunteer will be asked to sign a consent form. After informed consent each volunteer will be assigned a unique volunteer number for the duration of the trial to provide anonymity. The volunteer will be provided with a daily diary, urine collection material and a full set of volunteer instructions. The daily diary will collect the following information; * Date * Whether or not supplement was taken and time taken * sample collection times during the day Volunteers will be requested to: Day 1: Collect a urine sample from every void during the day. Days 2-6: Take biotin supplements with their evening meal and collect a urine sample from every void during the day Day 7: Collect a urine sample from every void during the day All samples will be stored in the SPD Bio-bank until required for analysis.

Conditions

• Healthy Volunteers
• Biotin Excretion

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	Biotin	Biotin supplements (2) to be taken daily

Timeline

• Start date: 2018-11-07
• Primary completion: 2018-12-30
• Completion: 2018-12-30
• First posted: 2018-11-20
• Last updated: 2019-02-08

Locations

1 site across 1 country: United Kingdom