MedPath

Trace Element Replenishment Study in Hemodialysis Patients

Phase 3
Completed
Conditions
End Stage Renal Disease
Registration Number
NCT01473914
Lead Sponsor
Marcello Tonelli
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 the renal vitamin currently being prescribed to people with End Stage Renal Disease (ESRD).

Secondary objective is to demonstrate the feasibility of recruitment for a definitive larger trial.

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 and vegetables, which may lead to nutritional deficiency. Although the potential for malnutrition in people with kidney disease is well recognized, blood levels of most vitamins and trace elements are rarely measured. Instead, most North Americans with severe kidney disease are routinely prescribed a "renal vitamin" such as Replavite which contains a mixture of B and C vitamins.

Recent evidence (including our work; see http://www.biomedcentral.com/bmcmed/subjects/nephrology) indicates that people with severe kidney disease are often deficient in several other biologically essential substances (selenium, zinc) that are readily amenable to supplementation. Pilot data from the Northern Alberta Renal Program (NARP) indicate that approximately 90% of patients have zinc levels below the lower limit of normal; findings for selenium are similar.

Potential benefits of zinc supplementation include improvements in immune function, taste sensitivity (perhaps reducing dietary sodium intake), and improved appetite. Potential benefits of selenium supplementation include reductions in the risk of vascular disease and infection. Supplementation with vitamin E was shown in a randomized trial to reduce serious cardiovascular morbidity in people with kidney failure, but is not routinely used in dialysis patients. This suggests that supplementation of zinc, selenium, and vitamin E has theoretical benefits in kidney failure. Since patients with kidney failure already take many medications, it is logical to combine any new nutritional supplements with the ingredients of the standard renal vitamin to reduce pill burden.

This protocol concerns a novel nutritional supplement consisting of zinc, selenium and vitamin E in addition to the contents of the standard renal supplement of B and C vitamins.

This pilot randomized, double blind trial will compare 2 doses of the new supplement with the standard renal vitamin.

2.0 Objectives: Primary objective: compare two formulations of the new supplement (low and medium doses of zinc and selenium) with standard treatment (Replavite or equivalent renal vitamin).

Secondary objective: demonstrate the feasibility of recruitment for a definitive larger trial

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
150
Inclusion Criteria
  1. Stable on hemodialysis for 3 to 36 months
  2. Age greater or equal to 18 years
  3. Receiving Replavite or equivalent renal vitamin at baseline
  4. Receiving 3 dialysis treatments per week
Exclusion Criteria
  1. Pregnant (sexually active pre-menopausal females must have negative serum pregnancy test at baseline)
  2. Pregnancy, kidney transplantation, a dialysis modality switch, or gastrointestinal surgery planned within 6 months
  3. Known allergy to corn starch
  4. Known allergy to zinc, selenium, vitamin E or renal vitamin.
  5. Projected life expectancy of <6 months
  6. Any other conditions or procedures that, in the opinion of the investigator, would impede absorption of the study product.
  7. Participants already taking a vitamin E, zinc or selenium supplement (alone or included in another multi-vitamin).
  8. Individuals with a history of head or neck cancer in the past 5 years.
  9. Ostomy or short gut syndrome.
  10. Enroll in another (interventional) trial.

Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Primary Outcome Measures
NameTimeMethod
Proportion of participants with zinc deficiency90 days following baseline

Proportion of participants with zinc deficiency in the combined experimental arms compared to the proportion of participants with zinc deficiency in the active comparator arm.

Secondary Outcome Measures
NameTimeMethod
Proportion of participants with zinc deficiency180 days following baseline

The proportion of participants with zinc deficiency in each arm compared to each other arm at each time point.

Proportion of participants with selenium deficiency90 days and 180 days following baseline

The proportion of participants with selenium deficiency in each arm compared to each other arm at each time point.

Zinc90 days and 180 days following baseline

Zinc concentration in each arm compared to each other arm.

Selenium90 days and 180 days following baseline

Selenium concentration measured in each arm compared to each other arm.

Trial Locations

Locations (2)

University of Calgary

🇨🇦

Calgary, Alberta, Canada

University of Alberta

🇨🇦

Edmonton, Alberta, Canada

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