Status:
COMPLETED
Trace Element Replenishment Study in Hemodialysis Patients
Lead Sponsor:
Marcello Tonelli
Collaborating Sponsors:
Alberta Health services
Conditions:
End Stage Renal Disease
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
A pilot randomized trial that compares a new renal nutritional supplement with the standard renal vitamin. The primary objective is to compare two doses (medium and high) of the new supplement with t...
Detailed Description
People with severe kidney disease follow a restricted diet aimed at reducing intake of sodium, potassium and phosphate. These dietary restrictions require reducing their intake of many fresh fruits an...
Eligibility Criteria
Inclusion
- Stable on hemodialysis for 3 to 36 months
- Age greater or equal to 18 years
- Receiving Replavite or equivalent renal vitamin at baseline
- Receiving 3 dialysis treatments per week
Exclusion
- Pregnant (sexually active pre-menopausal females must have negative serum pregnancy test at baseline)
- Pregnancy, kidney transplantation, a dialysis modality switch, or gastrointestinal surgery planned within 6 months
- Known allergy to corn starch
- Known allergy to zinc, selenium, vitamin E or renal vitamin.
- Projected life expectancy of \<6 months
- Any other conditions or procedures that, in the opinion of the investigator, would impede absorption of the study product.
- Participants already taking a vitamin E, zinc or selenium supplement (alone or included in another multi-vitamin).
- Individuals with a history of head or neck cancer in the past 5 years.
- Ostomy or short gut syndrome.
- Enroll in another (interventional) trial.
Key Trial Info
Start Date :
November 1 2012
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2014
Estimated Enrollment :
150 Patients enrolled
Trial Details
Trial ID
NCT01473914
Start Date
November 1 2012
End Date
January 1 2014
Last Update
December 16 2016
Active Locations (2)
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1
University of Calgary
Calgary, Alberta, Canada, T2N 1N4
2
University of Alberta
Edmonton, Alberta, Canada, T6G 2V2