Chronic Kidney Disease Clinical Trial
— PATCHOfficial title:
Palm Tocotrienols in Chronic Hemodialysis (PATCH Study)
Verified date | August 2022 |
Source | Wayne State University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 280 |
Est. completion date | August 31, 2020 |
Est. primary completion date | June 30, 2020 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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. |
Country | Name | City | State |
---|---|---|---|
United States | Wayne State University | Detroit | Michigan |
Lead Sponsor | Collaborator |
---|---|
Wayne State University | DaVita Dialysis, Fortis Hospital, India, Great Lakes Dialysis, LLC, Henry Ford Hospital, Kidney Foundation Hospital and Research Institute, Bangladesh, Ministry of Health, Malaysia, National Kidney Foundation, National University of Malaysia, PEMANDU, Universiti Putra Malaysia |
United States,
Daud 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. — View Citation
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. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Inflammatory markers | measurement of hsCRP from blood samples | Every 3 months, upto 15 months | |
Secondary | Plasma lipids | TC, TAG, HDL-C (all in mg/dL plasma) | Every 3 months, upto 15 months | |
Secondary | 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. | Every 3 months, upto 15 months | |
Secondary | Dietary history | A diet questionnaire based on a 24 h diet recall | Every 3 months, upto 15 months |
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