NCT03746821

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
12

participants targeted

Target at below P25 for not_applicable healthy-volunteers

Timeline
Completed

Started Nov 2018

Shorter than P25 for not_applicable healthy-volunteers

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 7, 2018

Completed
1 day until next milestone

First Submitted

Initial submission to the registry

November 8, 2018

Completed
12 days until next milestone

First Posted

Study publicly available on registry

November 20, 2018

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 30, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2018

Completed
Last Updated

February 8, 2019

Status Verified

February 1, 2019

Enrollment Period

2 months

First QC Date

November 8, 2018

Last Update Submit

February 7, 2019

Conditions

Healthy VolunteersBiotin Excretion

Outcome Measures

Primary Outcomes (1)

  • Biotin excretion

    rate of biotin excretion in urine

    2 months

Study Arms (1)

Biotin

OTHER

Volunteers to take biotin suppliment

Dietary Supplement: Biotin

Interventions

BiotinDIETARY_SUPPLEMENT

Biotin supplements (2) to be taken daily

Biotin

Eligibility Criteria

Age18 Years - 45 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

SPD Development Company Ltd

Bedford, Bedfordshire, MK44 3UP, United Kingdom

Location

MeSH Terms

Interventions

Biotin

Intervention Hierarchy (Ancestors)

ImidazolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsCoenzymesEnzymes and Coenzymes

Study Officials

  • Sarah Johnson, Dr

    SPD Development company Ltd.

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 8, 2018

First Posted

November 20, 2018

Study Start

November 7, 2018

Primary Completion

December 30, 2018

Study Completion

December 30, 2018

Last Updated

February 8, 2019

Record last verified: 2019-02

Data Sharing

IPD Sharing
Will not share

sample collection study only

Locations

GB(1)