Biotin Sample Collection Study

Not Applicable

Completed

• Conditions: Healthy Volunteers; Biotin Excretion
• Interventions: Dietary Supplement: Biotin

• Registration Number: NCT03746821
• Lead Sponsor: SPD Development Company Limited

Brief 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.

Study Timeline

• Study Start: 2018-11-07
• Study First Submitted: 2018-11-08
• Study First Submitted QC: 2018-11-15
• Study First Posted: 2018-11-20
• Primary Completion: 2018-12-30
• Study Completion: 2018-12-30
• Status Verified: 2019-02
• Last Update Submitted: 2019-02-07
• Last Update Posted: 2019-02-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 12

Inclusion Criteria

• Willing to take biotin supplements and collect urine samples
• Has regular menstrual periods
• SPD employee or partner of SPD employee

Exclusion Criteria

• Taking any other supplements or medication (other than contraceptive pill)
• Taken Antibiotics in the last 4 weeks
• Diagnosed with metabolic disorder, kidney or liver disease
• Known Pregnancy or seeking to conceive
• Breast feeding
• Undergoing medical investigation for hormone imbalance
• Condition that contra-indicates pregnancy
• Condition that contra-indicates use of biotin supplements

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Biotin	Biotin	Volunteers to take biotin suppliment

Primary Outcome Measures

Name	Time	Method
Biotin excretion	2 months	rate of biotin excretion in urine

Trial Locations

Locations (1)

SPD Development Company Ltd; 🇬🇧 Bedford, Bedfordshire, United Kingdom