End Stage Cardiac FailureEarly Phase 1NCT00678834
Human Tissue Distribution of Orally Supplemented Natural Vitamin E Tocotrienol
A Early Phase 1 study testing To surgery patients, Tocopherol capsules., Tocotrienol to healthy subjects. and To surgery patients, Tocotrienol capsules. in people with End Stage Cardiac Failure and Pulmonary Failure, run by Chandan K Sen at 1 site in United States.
Trial summary
Levels of tocotrienol in human tissues following supplementation is not currently known. The objective of this present study is to determine the levels of this form of vitamin E in the human tissues such as skin, heart, lung, liver, adipose tissue, Brain and cerebrospinal fluid (CSF) following oral supplementation Read more about this study
- Who is it for?
- Ages 21 years and olderHealthy volunteers can take part
- Conditions the study is for
- End Stage Cardiac Failure, Pulmonary Failure, End Stage Liver Disease
- What is being tested?
- To surgery patients, Tocopherol capsules., Tocotrienol to healthy subjects. and To surgery patients, Tocotrienol capsules.
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2006to Jun 2012
- Phase
- Early Phase 1
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 21 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- age 21 and older
- good health
- non- smoker
- no current medications
- non- pregnant or non-breastfeeding
- no previous use of OTC medications or other form of supplements containing vitamin-E.
Show all 12Show fewer
- age 21 - 40 years
- good health
- non- smoker
- no current medications
- non- pregnant or non-breastfeeding
- no previous use of OTC medications or other form of supplements containing vitamin-E.
Who cannot join
- Long-term use of OTC medications containing vitamin-E or current vitamin-E supplements
- Scheduled surgery date lesser than 4 weeks or greater than 24 weeks.
- Over 40 or under 21 years of age
- Current smoker
- Pregnant and breastfeeding
- Diabetes and HIV diagnosis
Show all 10Show fewer
- Immunosuppression therapy
- Any neurological problems
- Long-term use of OTC medications containing vitamin-E or current vitamin-E supplements
- ETOH or drug abuse
Trial locations and contacts
1 site in 1 country.
About this study
Levels of tocotrienol in human tissues following supplementation is not currently known. The objective of this present study is to determine the levels of this form of vitamin E in the human tissues such as skin, heart, lung, liver, adipose tissue, Brain and cerebrospinal fluid (CSF) following oral supplementation
Read the detailed description
In nature, there are eight members in the vitamin E family: a-, b-, g- and d-TCP, and a-, b-, g- and d-tocotrienol (TCT). Vitamin E research has developed highly asymmetrically. Out of the 25,000+ papers on vitamin E in the PubMed, 99% deal with tocopherols. Recent research has demonstrated the lack of cancer-preventive effects and potential adverse health consequences of tocopherol (6). As a result, more attention has been turned towards non-tocopherol forms of vitamin E (16). Palm oil represents a major source of natural TCT. TCT possess powerful neuroprotective, antioxidant, anti-cancer and cholesterol lowering properties that often differ from the properties of TCP (15).
During the last five years, our and other laboratories have reported several striking beneficial properties of tocotrienols in experimental settings. One major concern that limits enthusiasm for tocotrienol for humans is the report that the vitamin E transporting protein, tocopherol-transport protein (TTP), has a very low affinity to transport tocotrienol. Using TTP-knock out mice, we have recently demonstrated that oral TCT is effectively carried to vital organs and that such transport can take place independent of TTP. With that background, the purpose of this project is to test the hypothesis that orally supplemented tocotrienol reaches the vital organs of humans.
- Conditions
- End Stage Cardiac Failure, Pulmonary Failure, End Stage Liver Disease, Morbid Obesity, Recalcitrant Epilepsy Requiring Surgery, Healthy Subjects
- Being tested
- To surgery patients, Tocopherol capsules., Tocotrienol to healthy subjects., To surgery patients, Tocotrienol capsules.
- Medical subject headings
- End Stage Liver Disease, Obesity, Morbid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
To surgery patients, Tocopherol capsules.Dietary supplement
200mg (2 100mg capsules) to take by mouth twice daily to total 400mg daily
Tocotrienol to healthy subjects.Dietary supplement
200 mg to take orally two times a day (400 mg a day).
To surgery patients, Tocotrienol capsules.Dietary supplement
200mg (2 100mg capsules) to take by mouth twice daily to total 400mg daily
| Study group | Role | What they receive |
|---|---|---|
| Arm 1 | Active comparator | To surgery patients, Tocotrienol capsules. 200mg (2 100mg capsules) to take by mouth twice daily to total 400mg daily Receives: Dietary Supplement: To surgery patients, Tocotrienol capsules. |
| Arm 2 | Active comparator | To surgery patients, Tocopherol capsules. 200mg (2 100mg capsules) to take by mouth twice daily to total 400mg daily Receives: Dietary Supplement: To surgery patients, Tocopherol capsules. |
| Arm 3 | Active comparator | Tocotrienol to healthy subjects - 200 mg to take orally two times a day (400 mg a day). Receives: Dietary Supplement: Tocotrienol to healthy subjects. |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Levels of TCT in the Tissues of "Non-healthy" Subjects and in the Tissue of "Healthy" Subjects Following Oral Supplementation (200 mg x 2 Per Day for 4-24 Weeks)
Measured: After at least 1 month of supplementation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 May 2008 (estimated)
- Study startMar 2006
- Primary completionJun 2012
- Study completionJun 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for End Stage Cardiac FailureStudies 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
- Early Phase 1
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chandan K Sen
- Sponsor type
- University, hospital or other
- Collaborators
- Carotech Inc.
- Responsible party
- Sponsor-investigator, Chandan K Sen, Ohio State University
- Investigators
- Chandan Sen, PhD, Principal investigator, Ohio State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00678834
- Sponsor's protocol ID
- 2005C0034
- Status last verified
- Jul 2014
- First submitted
- 14 May 2008
- Last updated
- 16 Sep 2014
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
Patel V, Rink C, Gordillo GM, Khanna S, Gnyawali U, Roy S, Shneker B, Ganesh K, Phillips G, More JL, Sarkar A, Kirkpatrick R, Elkhammas EA, Klatte E, Miller M, Firstenberg MS, Chiocca EA, Nesaretnam K, Sen CK. Oral tocotrienols are transported to human tissues and delay the progression of the model for end-stage liver disease score in patients. J Nutr. 2012 Mar;142(3):513-9. doi: 10.3945/jn.111.151902. Epub 2012 Feb 1.
PubMed 22298568
Study at a glance
From the registry record, last updated by the sponsor on 16 Sep 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Human Tissue Distribution of Orally Supplemented Natural Vitamin E Tocotrienol
- ClinicalTrials.gov ID
- NCT00678834
- Acronym / sponsor ID
- 2005C0034
- Conditions
- End Stage Cardiac Failure, Pulmonary Failure, End Stage Liver Disease, Morbid Obesity, Recalcitrant Epilepsy Requiring Surgery, Healthy Subjects
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Chandan K SenUniversity, hospital or other
- Collaborators
- Carotech Inc.
- Study start
- Mar 2006
- Primary completion
- Jun 2012 (actual)
- Study completion
- Jun 2012 (actual)
- First posted
- 16 May 2008 (estimated)
- Results
- Posted 16 Sep 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Levels of tocotrienol in human tissues following supplementation is not currently known. The objective of this present study is to determine the levels of this form of vitamin E in the human tissues such as skin, heart, lung, liver, adipose tissue, Brain and cerebrospinal fluid (CSF) following oral supplementation
Detailed description
In nature, there are eight members in the vitamin E family: a-, b-, g- and d-TCP, and a-, b-, g- and d-tocotrienol (TCT). Vitamin E research has developed highly asymmetrically. Out of the 25,000+ papers on vitamin E in the PubMed, 99% deal with tocopherols. Recent research has demonstrated the lack of cancer-preventive effects and potential adverse health consequences of tocopherol (6). As a result, more attention has been turned towards non-tocopherol forms of vitamin E (16). Palm oil represents a major source of natural TCT. TCT possess powerful neuroprotective, antioxidant, anti-cancer and cholesterol lowering properties that often differ from the properties of TCP (15).
During the last five years, our and other laboratories have reported several striking beneficial properties of tocotrienols in experimental settings. One major concern that limits enthusiasm for tocotrienol for humans is the report that the vitamin E transporting protein, tocopherol-transport protein (TTP), has a very low affinity to transport tocotrienol. Using TTP-knock out mice, we have recently demonstrated that oral TCT is effectively carried to vital organs and that such transport can take place independent of TTP. With that background, the purpose of this project is to test the hypothesis that orally supplemented tocotrienol reaches the vital organs of humans.
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Arm 1 | Active comparator | Dietary Supplement: To surgery patients, Tocotrienol capsules.To surgery patients, Tocotrienol capsules. 200mg (2 100mg capsules) to take by mouth twice daily to total 400mg daily |
| Arm 2 | Active comparator | Dietary Supplement: To surgery patients, Tocopherol capsules.To surgery patients, Tocopherol capsules. 200mg (2 100mg capsules) to take by mouth twice daily to total 400mg daily |
| Arm 3 | Active comparator | Dietary Supplement: Tocotrienol to healthy subjects.Tocotrienol to healthy subjects - 200 mg to take orally two times a day (400 mg a day). |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- age 21 and older
- good health
- non- smoker
- no current medications
- non- pregnant or non-breastfeeding
Key exclusion criteria (10 listed)
- Long-term use of OTC medications containing vitamin-E or current vitamin-E supplements
- Scheduled surgery date lesser than 4 weeks or greater than 24 weeks.
- Over 40 or under 21 years of age
- Current smoker
- Pregnant and breastfeeding
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 |
|---|---|---|
| To surgery patients, Tocopherol capsules.200mg (2 100mg capsules) to take by mouth twice daily to total 400mg daily | Dietary supplement | Arm 2 |
| Tocotrienol to healthy subjects.200 mg to take orally two times a day (400 mg a day). | Dietary supplement | Arm 3 |
| To surgery patients, Tocotrienol capsules.200mg (2 100mg capsules) to take by mouth twice daily to total 400mg daily | Dietary supplement | Arm 1 |
Primary outcome
The Levels of TCT in the Tissues of "Non-healthy" Subjects and in the Tissue of "Healthy" Subjects Following Oral Supplementation (200 mg x 2 Per Day for 4-24 Weeks)
Time frame: After at least 1 month of supplementation
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Sep 2014.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 22298568Patel V, Rink C, Gordillo GM, Khanna S, Gnyawali U, Roy S, Shneker B, Ganesh K, Phillips G, More JL, Sarkar A, Kirkpatrick R, Elkhammas EA, Klatte E, Miller M, Firstenberg MS, Chiocca EA, Nesaretnam K, Sen CK. Oral tocotrienols are transported to human tissues and delay the progression of the model for end-stage liver disease score in patients. J Nutr. 2012 Mar;142(3):513-9. doi: 10.3945/jn.111.151902. Epub 2012 Feb 1.
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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.
Chandan Sen, PhD principal investigator
Ohio State University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing To surgery patients, Tocopherol capsules., Tocotrienol to healthy subjects. and To surgery patients, Tocotrienol capsules. in people with End Stage Cardiac Failure and Pulmonary Failure, run by Chandan K Sen 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 12 inclusion and 10 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 16 Sep 2014. 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. 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?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 16 Sep 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
The Levels of TCT in the Tissues of "Non-healthy" Subjects and in the Tissue of "Healthy" Subjects Following Oral Supplementation (200 mg x 2 Per Day for 4-24 Weeks) (time frame: After at least 1 month of supplementation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00678834, which also lists 1 linked publication.
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 16 Sep 2014.