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Completed

NCT Number: NCT03746821

Biotin Sample 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

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Key information

Age range

18 year–45 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

SPD Development Company Ltd

Bedford, Bedfordshire, MK44 3UP, United Kingdom

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

biotin

Dietary Supplement

Biotin supplements (2) to be taken daily

Primary outcomes

  1. Biotin excretion

    Time frame: 2 months

    rate of biotin excretion in urine

Sponsors and collaborators

Lead sponsor

SPD Development Company Limited

Industry

Registry information

Official study title

Biotin Urine Collection Study

Important dates

Study start
2018
Primary completion
2018
Study completion
2018
First posted
Nov 20, 2018
Registry last updated
Feb 8, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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