Biotin Sample Collection Study

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

12 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-11-07

Study Completion Date

2018-12-30

Brief Summary

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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

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Detailed Description

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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

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Healthy Volunteers Biotin Excretion

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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Biotin

Volunteers to take biotin suppliment

Group Type OTHER

Biotin

Intervention Type DIETARY_SUPPLEMENT

Biotin supplements (2) to be taken daily

Interventions

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Biotin

Biotin supplements (2) to be taken daily

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes