Trace Element Replenishment Study in Hemodialysis Patients

December 14, 2016 updated by: Marcello Tonelli

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Study Type

Interventional

Enrollment (Actual)

150

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Alberta
      • Calgary, Alberta, Canada, T2N 1N4
        • University of Calgary
      • Edmonton, Alberta, Canada, T6G 2V2
        • University of Alberta

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Low dose

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
  1. ZINC 25mg (AS ZINC SULFATE)
  2. SELENIUM 50 mcg (AS SODIUM SELENITE)
  3. VITAMIN E (D-ALPHA-TOCOPHEROL) (AS SUCCINATE) 250 IU
Dietary supplement: Standard renal vitamin: B and C renal vitamin
  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)
Other Names:
  • Replavite
Experimental: Medium dose

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
  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)
Other Names:
  • Replavite
Dietary supplement: Medium dose: supplemental zinc, selenium and vitamin E
  1. ZINC 50 mg (AS ZINC SULFATE)
  2. SELENIUM 75 mcg (AS SODIUM SELENITE)
  3. VITAMIN E (D-ALPHA-TOCOPHEROL) (AS SUCCINATE) 250 IU
Active Comparator: Standard treatment

Standard renal vitamin

1 capsule p.o, daily
Dietary supplement: Standard renal vitamin: B and C renal vitamin
  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)
Other Names:
  • Replavite

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Proportion of participants with zinc deficiency
Time Frame: 90 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.
90 days following baseline

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Proportion of participants with zinc deficiency
Time Frame: 180 days following baseline
The proportion of participants with zinc deficiency in each arm compared to each other arm at each time point.
180 days following baseline
Proportion of participants with selenium deficiency
Time Frame: 90 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.
90 days and 180 days following baseline
Zinc
Time Frame: 90 days and 180 days following baseline
Zinc concentration in each arm compared to each other arm.
90 days and 180 days following baseline
Selenium
Time Frame: 90 days and 180 days following baseline
Selenium concentration measured in each arm compared to each other arm.
90 days and 180 days following baseline

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Proportions of participants with serious adverse events
Time Frame: 30 days following last day of intervention
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.
30 days following last day of intervention
Proportion of participants with adverse events
Time Frame: 30 days following last day of intervention
The proportion of participants with adverse events (and by each type of adverse event) in each arm compared to each other arm.
30 days following last day of intervention
Change in interdialytic weight
Time Frame: 90 days and 180 days following baseline
Change in interdialytic weight in each arm compared to each other arm.
90 days and 180 days following baseline
Salt sensitivity
Time Frame: 90 days and 180 days following baseline
The proportion of participants with recognized and detect salt sensitivities in each arm compared to each other arm.
90 days and 180 days following baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Marcello Tonelli

Collaborators

Alberta Health services

Investigators

  • Principal Investigator: Marcello A Tonelli, MD, University of Alberta

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2012

Primary Completion (Actual)

December 1, 2013

Study Completion (Actual)

January 1, 2014

Study Registration Dates

First Submitted

September 23, 2011

First Submitted That Met QC Criteria

November 14, 2011

First Posted (Estimate)

November 17, 2011

Study Record Updates

Last Update Posted (Estimate)

December 16, 2016

Last Update Submitted That Met QC Criteria

December 14, 2016

Last Verified

December 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TRSV1

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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