Trace Element Replenishment Study in Hemodialysis Patients
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
End Stage Renal Disease |
Dietary Supplement: B and C renal vitamin plus zinc, selenium and vitamin E Dietary Supplement: B and C renal vitamin |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Treatment |
| Official Title: | Trace Element Replenishment Study in Hemodialysis Patients |
- zinc deficiency [ Time Frame: At baseline, before starting the study treatment. ] [ Designated as safety issue: No ]Proportion of subjects in each group with serum zinc level less than the lower limit of normal for the general population.
- zinc deficiency [ Time Frame: 90 days after starting the study treatment ] [ Designated as safety issue: No ]Proportion of subjects in each group with serum zinc level less than the lower limit of normal for the general population.
- zinc deficiency [ Time Frame: 180 days after starting the study treatment ] [ Designated as safety issue: No ]Proportion of subjects in each group with serum zinc level less than the lower limit of normal for the general population.
- selenium deficiency [ Time Frame: At baseline, 90 and 180 days after starting the study treatment ] [ Designated as safety issue: No ]Proportion of subjects with serum zinc level less than the lower limit of normal for the general population.
- Change in extracellular fluid status [ Time Frame: Assessed at day 0, day 90 and day 180 ] [ Designated as safety issue: No ]The intradialytic weight gain during the week before start of study treatment will be compared to the intradialytic weight gain on day 90 and day 180 of study treatment.
- Salt Sensitivity [ Time Frame: Baseline and 90 and 180 days after commencement of study treatment ] [ Designated as safety issue: No ]Compare levels of recognition and detection thresholds of salt sensitivity (taste) between baseline and days 90 and 180.
- Serious Adverse Events [ Time Frame: Between days 0 and 180 ] [ Designated as safety issue: Yes ]The occurrence of Serious Adverse Events (death, life threatening illness, hospitalization or prolongation of existing hospitalization and result in persistent or significant disability.
| Estimated Enrollment: | 135 |
| Study Start Date: | November 2012 |
| Estimated Study Completion Date: | July 2013 |
| Estimated Primary Completion Date: | July 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Active Comparator: Low dose arm
Standard renal vitamin plus low dose zinc and selenium plus vitamin E
|
Dietary Supplement: B and C renal vitamin plus zinc, selenium and vitamin E
1 capsule p.o, daily
Other Name: Replavite plus zinc, selenium and vitamin E
|
|
Active Comparator: medium dose arm
standard renal vitamin plus medium doses of zinc and selenium plus vitamin E
|
Dietary Supplement: B and C renal vitamin plus zinc, selenium and vitamin E
1 capsule p.o, daily
Other Name: Replavite plus zinc, selenium and vitamin E
|
|
Active Comparator: Standard treatment
Standard renal vitamin
|
Dietary Supplement: B and C renal vitamin
1 capsule p.o, daily
Other Name: Replavite
|
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
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- 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 Criteria:
- 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.
- Subjects already taking a 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.
Contacts and Locations| Contact: L |
| Canada, Alberta | |
| University of Calgary | Recruiting |
| Calgary, Alberta, Canada, T2N 1N4 | |
| Contact: Nancy Ruholl 780 407-1460 nruholl@ualberta.ca | |
| University of Alberta | Recruiting |
| Edmonton, Alberta, Canada, T6G 2V2 | |
| Contact: Nancy Ruholl 780 407-1460 nruholl@ualberta.ca | |
| Principal Investigator: | Marcello A Tonelli, MD | University of Alberta |
More Information
No publications provided
| Responsible Party: | Marcello Tonelli, MD, Associate Professor, University of Alberta |
| ClinicalTrials.gov Identifier: | NCT01473914 History of Changes |
| Other Study ID Numbers: | TRSV1 |
| Study First Received: | September 23, 2011 |
| Last Updated: | April 4, 2013 |
| Health Authority: | Canada: Health Canada |
Additional relevant MeSH terms:
|
Kidney Diseases Kidney Failure, Chronic Urologic Diseases Renal Insufficiency, Chronic Renal Insufficiency Selenium Trace Elements Zinc Vitamin E Alpha-Tocopherol |
Tocopherols Tocotrienols Micronutrients Vitamins Growth Substances Physiological Effects of Drugs Pharmacologic Actions Antioxidants Molecular Mechanisms of Pharmacological Action Protective Agents |
ClinicalTrials.gov processed this record on May 16, 2013