Biotin Sample Collection Study

February 7, 2019 updated by: SPD Development Company Limited

Biotin Urine Collection Study

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

12

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United Kingdom
    • Bedfordshire
      • Bedford, Bedfordshire, United Kingdom, MK44 3UP
        • SPD Development Company Ltd

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 45 years (ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: BASIC_SCIENCE
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
OTHER: Biotin
Volunteers to take biotin suppliment
Dietary supplement: Biotin
Biotin supplements (2) to be taken daily

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Biotin excretion
Time Frame: 2 months
rate of biotin excretion in urine
2 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

SPD Development Company Limited

Investigators

  • Study Director: Sarah Johnson, Dr, SPD Development company Ltd.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

November 7, 2018

Primary Completion (ACTUAL)

December 30, 2018

Study Completion (ACTUAL)

December 30, 2018

Study Registration Dates

First Submitted

November 8, 2018

First Submitted That Met QC Criteria

November 15, 2018

First Posted (ACTUAL)

November 20, 2018

Study Record Updates

Last Update Posted (ACTUAL)

February 8, 2019

Last Update Submitted That Met QC Criteria

February 7, 2019

Last Verified

February 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PROTOCOL-1001

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

sample collection study only

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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