A Phase 3 interventional study of Low dose: supplemental zinc, selenium and vitamin E and Standard renal vitamin: B and C renal vitamin in End Stage Renal Disease, sponsored by Marcello Tonelli. Completed at 2 sites in Canada. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2016-12-16.
Sponsored by Marcello Tonelli · Phase 3, Interventional, and Treatment
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.
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
2,085 studies on the registry are indexed under Kidney Failure, Chronic; 260 are open to participants now.
This study's enrollment of 150 is above the median of 55 across 1,557 interventional studies indexed under Kidney Failure, Chronic.
Browse Kidney Failure, Chronic studies →This is the only study on the registry with Marcello Tonelli as lead sponsor.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Standard renal vitamin plus low dose zinc and selenium plus vitamin E 1 capsule p.o, daily
Dietary Supplement: Low dose: supplemental zinc, selenium and vitamin E · Dietary Supplement: Standard renal vitamin: B and C renal vitamin
Standard renal vitamin plus medium doses of zinc and selenium plus vitamin E 1 capsule p.o, daily
Dietary Supplement: Standard renal vitamin: B and C renal vitamin · Dietary Supplement: Medium dose: supplemental zinc, selenium and vitamin E
Standard renal vitamin 1 capsule p.o, daily
Dietary Supplement: Standard renal vitamin: B and C renal vitamin
1. ZINC 25mg (AS ZINC SULFATE) 2. SELENIUM 50 mcg (AS SODIUM SELENITE) 3. VITAMIN E (D-ALPHA-TOCOPHEROL) (AS SUCCINATE) 250 IU
1. BIOTIN 300 MCG 2. D-PANTOTHENIC ACID (CALCIUM D-PANTOTHENATE) 10 MG 3. FOLIC ACID 1 MG 4. NIACINAMIDE 20 MG 5. VITAMIN B1 (THIAMINE MONONITRATE) 1.5 MG 6. VITAMIN B12(CYANOCOBALAMIN) 6 MCG 7. VITAMIN B2 (RIBOFLAVIN) 1.7 MG 8. VITAMIN B6 (PYRIDOXINE HYDROCHLORIDE) 10 MG 9. VITAMIN C (ASCORBIC ACID) 100 MG 10. INERT FILLER (CORNSTARCH)
Also known as: Replavite
1. ZINC 50 mg (AS ZINC SULFATE) 2. SELENIUM 75 mcg (AS SODIUM SELENITE) 3. VITAMIN E (D-ALPHA-TOCOPHEROL) (AS SUCCINATE) 250 IU
Proportion of participants with zinc deficiency
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.
Time frame: 90 days following baseline
Proportion of participants with zinc deficiency
The proportion of participants with zinc deficiency in each arm compared to each other arm at each time point.
Time frame: 180 days following baseline
Proportion of participants with selenium deficiency
The proportion of participants with selenium deficiency in each arm compared to each other arm at each time point.
Time frame: 90 days and 180 days following baseline
Zinc
Zinc concentration in each arm compared to each other arm.
Time frame: 90 days and 180 days following baseline
Selenium
Selenium concentration measured in each arm compared to each other arm.
Time frame: 90 days and 180 days following baseline
Proportions of participants with serious adverse events
The proportion of participants in each arm compared to each other arm experiencing serious adverse events resulting in death, life threatening illness, hospitalization or prolongation of existing hospitalization, or persistent or significant disability.
Time frame: 30 days following last day of intervention
Proportion of participants with adverse events
The proportion of participants with adverse events (and by each type of adverse event) in each arm compared to each other arm.
Time frame: 30 days following last day of intervention
Change in interdialytic weight
Change in interdialytic weight in each arm compared to each other arm.
Time frame: 90 days and 180 days following baseline
Salt sensitivity
The proportion of participants with recognized and detect salt sensitivities in each arm compared to each other arm.
Time frame: 90 days and 180 days following baseline
Plan to share: No
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