Palm Tocotrienols in Chronic Hemodialysis (USA)
PATCH
1 other identifier
interventional
280
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Jun 2017
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 30, 2015
CompletedFirst Posted
Study publicly available on registry
February 9, 2015
CompletedStudy Start
First participant enrolled
June 15, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 30, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
August 31, 2020
CompletedAugust 10, 2022
August 1, 2022
3 years
January 30, 2015
August 8, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Inflammatory markers
measurement of hsCRP from blood samples
Every 3 months, upto 15 months
Secondary Outcomes (3)
Plasma lipids
Every 3 months, upto 15 months
Restless Legs Syndrome
Every 3 months, upto 15 months
Dietary history
Every 3 months, upto 15 months
Study Arms (2)
Placebo
PLACEBO COMPARATORStandard renal care + 300 mg placebo daily for 1 year
Treatment
ACTIVE COMPARATORStandard renal care + 300 mg TRF daily for 1 year
Interventions
2 x 150 mg capsules
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Wayne State Universitylead
- DaVita, Inc.collaborator
- Great Lakes Dialysis, LLCcollaborator
- National University of Malaysiacollaborator
- Universiti Putra Malaysiacollaborator
- Ministry of Health, Malaysiacollaborator
- National Kidney Foundation, United Statescollaborator
- PEMANDUcollaborator
- Henry Ford Hospitalcollaborator
- Kidney Foundation Hospital and Research Institute, Bangladeshcollaborator
- Fortis Hospital, Indiacollaborator
Study Sites (1)
Wayne State University
Detroit, Michigan, 48202, United States
Related Publications (2)
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.
PMID: 24348043BACKGROUNDDaud 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.
PMID: 22536073BACKGROUND
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Pramod Khosla, PhD
Wayne State University
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- OTHER
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
January 30, 2015
First Posted
February 9, 2015
Study Start
June 15, 2017
Primary Completion
June 30, 2020
Study Completion
August 31, 2020
Last Updated
August 10, 2022
Record last verified: 2022-08