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Biotin Sample Collection Study

Biotin Urine Collection Study

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03746821
Enrollment
12
Registered
2018-11-20
Start date
2018-11-07
Completion date
2018-12-30
Last updated
2019-02-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Biotin Excretion, Healthy Volunteers

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.

Interventions

DIETARY_SUPPLEMENTBiotin

Biotin supplements (2) to be taken daily

Sponsors

SPD Development Company Limited
Lead SponsorINDUSTRY

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
BASIC_SCIENCE
Masking
NONE

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 45 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Biotin excretion2 monthsrate of biotin excretion in urine

Countries

United Kingdom

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026