End Stage Renal DiseasePATCHNCT02358967
Palm Tocotrienols in Chronic Hemodialysis (USA)
A study testing TRF (Tocotrienol-rich-fraction) in people with End Stage Renal Disease and Chronic Kidney Disease, run by Wayne State University at 1 site in United States.
Trial summary
Patients undergoing chronic hemodialysis are at increased risk for cardiovascular disease, attributed in part to increased oxidative stress, inflammation and dyslipidemia. Intervention with a naturally occurring dietary supplement may improve certain biomarkers of inflammation and oxidative stress and improve the… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- End Stage Renal Disease, Chronic Kidney Disease
- What is being tested?
- TRF (Tocotrienol-rich-fraction)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 280 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Jun 2017to 31 Aug 2020
- Phase
- Interventional
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patient is willing and able to give informed consent for participation in the trial.
- Male or Female, aged 18 years and above. Undergoing chronic hemodialysis treatment for more than 3 months (life expectancy > 1 year).
- Able and willing to comply with all trial requirements.
- Willing to allow his or her /Physician/Nephrologist/General Practitioner and consultant, if appropriate, to be notified of participation in the trial.
Who cannot join
- Participants who have participated in another research trial involving an investigational product in the past 12 weeks.
- History of functional kidney transplant 6 months before study entry; anticipated live donor kidney transplant over the study duration;
- Participants who are taking vitamin E- containing supplements >60 IU/d during the past 30 days
- History of poor adherence to hemodialysis or medical regimen
- Participants who are currently on active treatment for cancer, excluding basal cell carcinoma of the skin
- Participants who have been diagnosed as HIV/AIDS and/or on the anti-HIV therapy. (HIV seropositivity is not an exclusion criterion)
Show all 12Show fewer
- Patients taking anti-inflammatory medication, except aspirin<325 mg/d, over the past 30 days
- Female participant who is pregnant, lactating or planning pregnancy during the course of the trial
- Participants who are receiving nutritional support (i.e. enteral and intra-venous route)
- Patients using a temporary catheter for dialysis access at baseline or patients receiving a graft/fistula within the 6-month study period
- More than two hospitalizations within the last 90 days or one hospitalization within the 30 days preceding enrollment
- Any other significant disease or disorder which, in the opinion of their nephrologist, may either put the participants at risk because of participation in the trial, or may influence the result of the trial, or the participant's ability to participate in the trial.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Palm Tocotrienols in Chronic Hemodialysis (PATCH Study)
Patients undergoing chronic hemodialysis are at increased risk for cardiovascular disease, attributed in part to increased oxidative stress, inflammation and dyslipidemia. Intervention with a naturally occurring dietary supplement may improve certain biomarkers of inflammation and oxidative stress and improve the lipid profile.
Read the detailed description
End stage renal disease (ESRD) patients who are undergoing hemodialysis (HD) have higher levels of blood markers which the body makes in response to increased stress and injury. An increase in these markers has been shown to be related to cardiovascular disease and death in ESRD patients. It is believed that taking antioxidants (e.g. Vitamin E) may decrease these markers. In a previous study in ESRD patients on HD, consumption of a Vitamin E tocotrienol-rich fraction (TRF) was found to improve some of these markers. The current study will follow a larger group of patients for a longer time period (1 year) and document effects on additional markers
The study will document the extent to which supplementation with TRF will improve markers of inflammation, oxidative stress as well as blood lipids in ESRD patients on chronic HD as compared to a placebo. Additionally, the study will aim to document any improvement in Restless Legs Syndrome - tingling sensation in the legs - (RLS) with TRF, based on a standard questionnaire.
The study will last for 15 months. At the start of the study basic patient information will be evaluated related to their monthly dialysis labs, inflammation and oxidative stress markers as well as general information about the patients in relation to their kidney disease. Patients will then be randomized into one of two groups. One group will receive TRF, daily, for 12 months while the second group will receive placebo, daily, for 12 months. Capsules will be administered in the dialysis clinic/unit at the start of each dialysis session (thrice weekly), while patients will be provided capsules to be consumed at home for the remaining four days of each week.
During the 12 month treatment period, patients will be questioned every three months at their dialysis units by study staff to obtain information on dialysis labs, medical condition, hospitalizations, and to check to see if they are taking the study capsules.
As part of their routine standard care, patients will continue to have monthly blood draws. For the purposes of this study, at each trimonthly blood draw, we will obtain additional blood to examine the markers related to oxidative stress, inflammation and lipids. A blood sample will also be collected at 15 months (3 months after patients stop taking capsules). Therefore over the course of the entire study, blood will obtained at baseline and 3, 6, 9 and 12 months (plus the 15 month follow-up sample).
At each trimonthly blood draw including the follow-up visit at 15 months, patients will also be verbally administered a Restless Legs Syndrome Questionnaire. In addition a dietitian member of the research team will administer a 24 hr diet recall questionnaire
Sample size was based on inflammatory markers (hsCRp and IL-6) as reported in earlier studies and a sample size of 175 per group was estimated to achieve a 80% power at p=0.05 significance level. Thus accounting for potential drop-outs over the 1 year of the study, target is recruitment of 400 patients total (200 for each group) in Detroit, MI.
(A similar study, following a similar protocol and using the same study design and intervention will recruit 400 patients total (200 for each group) in Kuala Lumpur, Malaysia).
- Conditions
- End Stage Renal Disease, Chronic Kidney Disease
- Being tested
- TRF (Tocotrienol-rich-fraction), Placebo
- Keywords
- ESRD, dyslipidemia, oxidative stress, inflammation, Hemodialysis, CKD
- Medical subject headings
- Kidney Failure, Chronic, Renal Insufficiency, Chronic, Dyslipidemias, Inflammation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TRF (Tocotrienol-rich-fraction)Dietary supplement
Also called Tocotrienols are a naturally ocurring form of Vitamin E
2 x 150 mg capsules
PlaceboDietary supplement
2 x 150 mg capsules
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Standard renal care + 300 mg placebo daily for 1 year Receives: Dietary Supplement: Placebo |
| Treatment | Active comparator | Standard renal care + 300 mg TRF daily for 1 year Receives: Dietary Supplement: TRF (Tocotrienol-rich-fraction) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Inflammatory markers
measurement of hsCRP from blood samples
Measured: Every 3 months, upto 15 months
Secondary outcomes (3)
Plasma lipids
TC, TAG, HDL-C (all in mg/dL plasma)
Measured: Every 3 months, upto 15 months
Restless Legs Syndrome
A questionnaire (Restless Legs Syndrome Rating Scale). The RLS questionnaire consists of 10 questions, each can be scored from 0 to 4 points. The final score can range from 0 to 40 points.
Measured: Every 3 months, upto 15 months
Dietary history
A diet questionnaire based on a 24 h diet recall
Measured: Every 3 months, upto 15 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Feb 2015 (estimated)
- Study start15 Jun 2017
- Primary completion30 Jun 2020
- Study completion31 Aug 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for End Stage Renal DiseaseStudies 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 N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 280 participants (actual)
Sponsor and investigators
- Lead sponsor
- Wayne State University
- Sponsor type
- University, hospital or other
- Collaborators
- DaVita, Inc., Great Lakes Dialysis, LLC, National University of Malaysia, Universiti Putra Malaysia, Ministry of Health, Malaysia, National Kidney Foundation, United States, PEMANDU, Henry Ford Hospital, Kidney Foundation Hospital and Research Institute, Bangladesh, Fortis Hospital, India
- Responsible party
- Principal investigator, Pramod Khosla, Wayne State University
- Investigators
- Pramod Khosla, PhD, Principal investigator, Wayne State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02358967
- Sponsor's protocol ID
- 123314MP4F
- Acronym
- PATCH
- Status last verified
- Aug 2022
- First submitted
- 30 Jan 2015
- Last updated
- 10 Aug 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Daud ZA, Tubie B, Sheyman M, Osia R, Adams J, Tubie S, Khosla P. Vitamin E tocotrienol supplementation improves lipid profiles in chronic hemodialysis patients. Vasc Health Risk Manag. 2013;9:747-61. doi: 10.2147/VHRM.S51710. Epub 2013 Nov 28.
PubMed 24348043Daud ZA, Tubie B, Adams J, Quainton T, Osia R, Tubie S, Kaur D, Khosla P, Sheyman M. Effects of protein and omega-3 supplementation, provided during regular dialysis sessions, on nutritional and inflammatory indices in hemodialysis patients. Vasc Health Risk Manag. 2012;8:187-95. doi: 10.2147/VHRM.S28739. Epub 2012 Mar 20.
PubMed 22536073
Study at a glance
From the registry record, last updated by the sponsor on 10 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Palm Tocotrienols in Chronic Hemodialysis (PATCH Study)
- ClinicalTrials.gov ID
- NCT02358967
- Acronym / sponsor ID
- PATCH / 123314MP4F
- Conditions
- End Stage Renal Disease, Chronic Kidney Disease
- Keywords
- ESRD, dyslipidemia, oxidative stress, inflammation, Hemodialysis, CKD
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 280 participants (actual)
- Lead sponsor
- Wayne State UniversityUniversity, hospital or other
- Collaborators
- DaVita, Inc., Great Lakes Dialysis, LLC, National University of Malaysia, Universiti Putra Malaysia, Ministry of Health, Malaysia, National Kidney Foundation, United States, PEMANDU, Henry Ford Hospital, Kidney Foundation Hospital and Research Institute, Bangladesh, Fortis Hospital, India
- Study start
- 15 Jun 2017 (actual)
- Primary completion
- 30 Jun 2020 (actual)
- Study completion
- 31 Aug 2020 (actual)
- First posted
- 9 Feb 2015 (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.
Patients undergoing chronic hemodialysis are at increased risk for cardiovascular disease, attributed in part to increased oxidative stress, inflammation and dyslipidemia. Intervention with a naturally occurring dietary supplement may improve certain biomarkers of inflammation and oxidative stress and improve the lipid profile.
Detailed description
End stage renal disease (ESRD) patients who are undergoing hemodialysis (HD) have higher levels of blood markers which the body makes in response to increased stress and injury. An increase in these markers has been shown to be related to cardiovascular disease and death in ESRD patients. It is believed that taking antioxidants (e.g. Vitamin E) may decrease these markers. In a previous study in ESRD patients on HD, consumption of a Vitamin E tocotrienol-rich fraction (TRF) was found to improve some of these markers. The current study will follow a larger group of patients for a longer time period (1 year) and document effects on additional markers
The study will document the extent to which supplementation with TRF will improve markers of inflammation, oxidative stress as well as blood lipids in ESRD patients on chronic HD as compared to a placebo. Additionally, the study will aim to document any improvement in Restless Legs Syndrome - tingling sensation in the legs - (RLS) with TRF, based on a standard questionnaire.
The study will last for 15 months. At the start of the study basic patient information will be evaluated related to their monthly dialysis labs, inflammation and oxidative stress markers as well as general information about the patients in relation to their kidney disease. Patients will then be randomized into one of two groups. One group will receive TRF, daily, for 12 months while the second group will receive placebo, daily, for 12 months. Capsules will be administered in the dialysis clinic/unit at the start of each dialysis session (thrice weekly), while patients will be provided capsules to be consumed at home for the remaining four days of each week.
During the 12 month treatment period, patients will be questioned every three months at their dialysis units by study staff to obtain information on dialysis labs, medical condition, hospitalizations, and to check to see if they are taking the study capsules.
As part of their routine standard care, patients will continue to have monthly blood draws. For the purposes of this study, at each trimonthly blood draw, we will obtain additional blood to examine the markers related to oxidative stress, inflammation and lipids. A blood sample will also be collected at 15 months (3 months after patients stop taking capsules). Therefore over the course of the entire study, blood will obtained at baseline and 3, 6, 9 and 12 months (plus the 15 month follow-up sample).
At each trimonthly blood draw including the follow-up visit at 15 months, patients will also be verbally administered a Restless Legs Syndrome Questionnaire. In addition a dietitian member of the research team will administer a 24 hr diet recall questionnaire
Sample size was based on inflammatory markers (hsCRp and IL-6) as reported in earlier studies and a sample size of 175 per group was estimated to achieve a 80% power at p=0.05 significance level. Thus accounting for potential drop-outs over the 1 year of the study, target is recruitment of 400 patients total (200 for each group) in Detroit, MI.
(A similar study, following a similar protocol and using the same study design and intervention will recruit 400 patients total (200 for each group) in Kuala Lumpur, Malaysia).
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Dietary Supplement: PlaceboStandard renal care + 300 mg placebo daily for 1 year |
| Treatment | Active comparator | Dietary Supplement: TRF (Tocotrienol-rich-fraction)Standard renal care + 300 mg TRF daily for 1 year |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patient is willing and able to give informed consent for participation in the trial.
- Male or Female, aged 18 years and above. Undergoing chronic hemodialysis treatment for more than 3 months (life expectancy > 1 year).
- Able and willing to comply with all trial requirements.
- Willing to allow his or her /Physician/Nephrologist/General Practitioner and consultant, if appropriate, to be notified of participation in the trial.
Key exclusion criteria (12 listed)
- Participants who have participated in another research trial involving an investigational product in the past 12 weeks.
- History of functional kidney transplant 6 months before study entry; anticipated live donor kidney transplant over the study duration;
- Participants who are taking vitamin E- containing supplements >60 IU/d during the past 30 days
- History of poor adherence to hemodialysis or medical regimen
- Participants who are currently on active treatment for cancer, excluding basal cell carcinoma of the skin
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 |
|---|---|---|
| TRF (Tocotrienol-rich-fraction)Also: Tocotrienols are a naturally ocurring form of Vitamin E2 x 150 mg capsules | Dietary supplement | Treatment |
| Placebo2 x 150 mg capsules | Dietary supplement | Placebo |
Primary outcome
Inflammatory markers
Time frame: Every 3 months, upto 15 months
measurement of hsCRP from blood samples
3 secondary outcomes
Plasma lipids
Time frame: Every 3 months, upto 15 months
Restless Legs Syndrome
Time frame: Every 3 months, upto 15 months
Dietary history
Time frame: Every 3 months, upto 15 months
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 10 Aug 2022.
- Background: PubMed 24348043Daud ZA, Tubie B, Sheyman M, Osia R, Adams J, Tubie S, Khosla P. Vitamin E tocotrienol supplementation improves lipid profiles in chronic hemodialysis patients. Vasc Health Risk Manag. 2013;9:747-61. doi: 10.2147/VHRM.S51710. Epub 2013 Nov 28.
- Background: PubMed 22536073Daud ZA, Tubie B, Adams J, Quainton T, Osia R, Tubie S, Kaur D, Khosla P, Sheyman M. Effects of protein and omega-3 supplementation, provided during regular dialysis sessions, on nutritional and inflammatory indices in hemodialysis patients. Vasc Health Risk Manag. 2012;8:187-95. doi: 10.2147/VHRM.S28739. Epub 2012 Mar 20.
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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.
Pramod Khosla, PhD principal investigator
Wayne State University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing TRF (Tocotrienol-rich-fraction) in people with End Stage Renal Disease and Chronic Kidney Disease, run by Wayne State University 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 4 inclusion and 12 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 10 Aug 2022. 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.
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?
Inflammatory markers (time frame: Every 3 months, upto 15 months). 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 NCT02358967, which also lists 2 linked publications.
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 10 Aug 2022.