Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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
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;
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Biotin | Other | Volunteers to take biotin suppliment |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Biotin | Dietary Supplement | Biotin supplements (2) to be taken daily |
|
| Measure | Description | Time Frame |
|---|---|---|
| Biotin excretion | rate of biotin excretion in urine | 2 months |
Not provided
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Sarah Johnson, Dr | SPD Development company Ltd. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| SPD Development Company Ltd | Bedford | Bedfordshire | MK44 3UP | United Kingdom |
sample collection study only
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D001710 | Biotin |
| ID | Term |
|---|---|
| D007093 | Imidazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| D003067 |
| Coenzymes |
| D045762 | Enzymes and Coenzymes |