Pharmacokinetics in Healthy SubjectsPhase 1NCT01433952
Pharmacokinetics of Oral Thiamine
A Phase 1 study testing Thiamine in people with Pharmacokinetics in Healthy Subjects, run by Baystate Medical Center at 1 site in United States.
Trial summary
Elevated levels of thiamine may increase cellular energy metabolism by increasing the activity of pyruvate dehydrogenase complex. This has been hypothesized to have a beneficial affect in patients with several diseases including sepsis, heart failure, and diabetes. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Pharmacokinetics in Healthy Subjects
- What is being tested?
- Thiamine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 14 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2009to Jul 2010
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Age between 18 and 55
Who cannot join
- Non dietary thiamine supplement within two weeks of the start of the study or during the study
- History of thiamine deficiency
- Anemia (Hgb<10)
- History of gastrointestinal absorption disorders
- Taking prescription or over-the-counter medication
- Pregnant or breast feeding a child
- Alcohol and or drug abuse
- Smoker
Trial locations and contacts
1 site in 1 country.
United States1 site
Baystate Medical Center
Springfield, Massachusetts, 01199
About this study
Official title: Pharmacokinetics of High Dose Oral Thiamine
Elevated levels of thiamine may increase cellular energy metabolism by increasing the activity of pyruvate dehydrogenase complex. This has been hypothesized to have a beneficial affect in patients with several diseases including sepsis, heart failure, and diabetes. There is limited data on the pharmacokinetics of supraphysiologic doses of oral thiamine.
The aims of this study are to:
- Calculate the plasma and whole blood pharmacokinetics of supraphysiologic doses of oral thiamine in healthy volunteers;
- Compare the different thiamine doses on the pharmacokinetic variables using repeated measures ANOVA.
- Conditions
- Pharmacokinetics in Healthy Subjects
- Being tested
- Thiamine, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ThiamineDietary supplement
Vitamin B1
PlaceboDietary supplement
Placebo
| Study group | Role | What they receive |
|---|---|---|
| 0 mg Thiamine | Placebo comparator | Not described Receives: Dietary Supplement: Placebo |
| 100 mg Thiamine | Experimental | Not described Receives: Dietary Supplement: Thiamine |
| 500 mg Thiamine | Experimental | Not described Receives: Dietary Supplement: Thiamine |
| 1500 mg Thiamine | Experimental | Not described Receives: Dietary Supplement: Thiamine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Area Under the Curve (AUC) for whole blood
Measured: predose, 0, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10 hours post-dose
Area Under the Curve (AUC) for plasma
Measured: predose, 0, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10 hours post-dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Sep 2011 (estimated)
- Study startJun 2009
- Primary completionJul 2010
- Study completionJul 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pharmacokinetics in Healthy SubjectsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 14 participants (actual)
Sponsor and investigators
- Lead sponsor
- Baystate Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Howard Smithline, MD, Principal investigator, Baystate Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01433952
- Sponsor's protocol ID
- 132653
- Status last verified
- Sep 2011
- First submitted
- 7 Sep 2011
- Last updated
- 14 Sep 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Sep 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pharmacokinetics of High Dose Oral Thiamine
- ClinicalTrials.gov ID
- NCT01433952
- Acronym / sponsor ID
- 132653
- Conditions
- Pharmacokinetics in Healthy Subjects
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 14 participants (actual)
- Lead sponsor
- Baystate Medical CenterUniversity, hospital or other
- Study start
- Jun 2009
- Primary completion
- Jul 2010 (actual)
- Study completion
- Jul 2010 (actual)
- First posted
- 14 Sep 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Elevated levels of thiamine may increase cellular energy metabolism by increasing the activity of pyruvate dehydrogenase complex. This has been hypothesized to have a beneficial affect in patients with several diseases including sepsis, heart failure, and diabetes. There is limited data on the pharmacokinetics of supraphysiologic doses of oral thiamine.
The aims of this study are to:
- Calculate the plasma and whole blood pharmacokinetics of supraphysiologic doses of oral thiamine in healthy volunteers;
- Compare the different thiamine doses on the pharmacokinetic variables using repeated measures ANOVA.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 0 mg Thiamine | Placebo comparator | Dietary Supplement: Placebo |
| 100 mg Thiamine | Experimental | Dietary Supplement: Thiamine |
| 500 mg Thiamine | Experimental | Dietary Supplement: Thiamine |
| 1500 mg Thiamine | Experimental | Dietary Supplement: Thiamine |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Age between 18 and 55
Key exclusion criteria (8 listed)
- Non dietary thiamine supplement within two weeks of the start of the study or during the study
- History of thiamine deficiency
- Anemia (Hgb<10)
- History of gastrointestinal absorption disorders
- Taking prescription or over-the-counter medication
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ThiamineVitamin B1 | Dietary supplement | 100 mg Thiamine, 1500 mg Thiamine, 500 mg Thiamine |
| PlaceboPlacebo | Dietary supplement | 0 mg Thiamine |
Primary outcome
Area Under the Curve (AUC) for whole blood
Time frame: predose, 0, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10 hours post-dose
Area Under the Curve (AUC) for plasma
Time frame: predose, 0, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10 hours post-dose
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Sep 2011.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Howard Smithline, MD principal investigator
Baystate Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Thiamine in people with Pharmacokinetics in Healthy Subjects, run by Baystate Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Sep 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Area Under the Curve (AUC) for whole blood (time frame: predose, 0, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10 hours post-dose). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Sep 2011.