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Palm Tocotrienols in Chronic Hemodialysis (USA) (PATCH)

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ClinicalTrials.gov Identifier: NCT02358967
Recruitment Status : Enrolling by invitation
First Posted : February 9, 2015
Last Update Posted : July 16, 2018
Sponsor:
Collaborators:
DaVita Dialysis
Great Lakes Dialysis, LLC
National University of Malaysia
Universiti Putra Malaysia
Ministry of Health, Malaysia
National Kidney Foundation
PEMANDU
Henry Ford Hospital
Information provided by (Responsible Party):
Pramod Khosla, Wayne State University

Brief 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 lipid profile.

Condition or disease Intervention/treatment Phase
End Stage Renal Disease Chronic Kidney Disease Dietary Supplement: TRF (Tocotrienol-rich-fraction) Dietary Supplement: Placebo Not Applicable

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 Type : Interventional  (Clinical Trial)
Estimated Enrollment : 400 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Other
Official Title: Palm Tocotrienols in Chronic Hemodialysis (PATCH Study)
Actual Study Start Date : June 15, 2017
Estimated Primary Completion Date : September 2019
Estimated Study Completion Date : December 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Dialysis Vitamin E

Arm Intervention/treatment
Placebo Comparator: Placebo
Standard renal care + 300 mg placebo daily for 1 year
Dietary Supplement: Placebo
2 x 150 mg capsules

Active Comparator: Treatment
Standard renal care + 300 mg TRF daily for 1 year
Dietary Supplement: TRF (Tocotrienol-rich-fraction)
2 x 150 mg capsules
Other Name: Tocotrienols are a naturally ocurring form of Vitamin E




Primary Outcome Measures :
  1. Blood lipids and inflammatory markers [ Time Frame: Every 3 months, upto 15 months ]
    measurement of TC, HDL-C, LDL-C, TG, IL-6 and hsCRP from blood samples


Secondary Outcome Measures :
  1. Restless Legs Syndrome [ Time Frame: Every 3 months, upto 15 months ]
    A questionnaire

  2. Dietary history [ Time Frame: Every 3 months, upto 15 months ]
    A diet questionnaire based on a 24 h diet recall



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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)
  • 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02358967


Locations
United States, Michigan
Wayne State University
Detroit, Michigan, United States, 48202
Sponsors and Collaborators
Wayne State University
DaVita Dialysis
Great Lakes Dialysis, LLC
National University of Malaysia
Universiti Putra Malaysia
Ministry of Health, Malaysia
National Kidney Foundation
PEMANDU
Henry Ford Hospital
Investigators
Principal Investigator: Pramod Khosla, PhD Wayne State University

Publications:
Responsible Party: Pramod Khosla, Associate Professor, Wayne State University
ClinicalTrials.gov Identifier: NCT02358967     History of Changes
Other Study ID Numbers: 123314MP4F
First Posted: February 9, 2015    Key Record Dates
Last Update Posted: July 16, 2018
Last Verified: July 2018

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Pramod Khosla, Wayne State University:
ESRD
dyslipidemia
oxidative stress
inflammation
Hemodialysis
CKD

Additional relevant MeSH terms:
Kidney Diseases
Renal Insufficiency, Chronic
Kidney Failure, Chronic
Urologic Diseases
Renal Insufficiency
Tocotrienols
Vitamin E
Tocopherols
Antioxidants
Molecular Mechanisms of Pharmacological Action
Protective Agents
Physiological Effects of Drugs
Vitamins
Micronutrients
Growth Substances