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Trace Element Replenishment Study in Hemodialysis Patients

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01473914
First Posted: November 17, 2011
Last Update Posted: December 16, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Alberta Health Services
Information provided by (Responsible Party):
Marcello Tonelli, University of Alberta
  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: Low dose: supplemental zinc, selenium and vitamin E Dietary Supplement: Standard renal vitamin: B and C renal vitamin Dietary Supplement: Medium dose: supplemental zinc, selenium and vitamin E Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Trace Element Replenishment Study in Hemodialysis Patients

Resource links provided by NLM:


Further study details as provided by Marcello Tonelli, University of Alberta:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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.

  • 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.

  • Zinc [ Time Frame: 90 days and 180 days following baseline ]
    Zinc concentration in each arm compared to each other arm.

  • Selenium [ Time Frame: 90 days and 180 days following baseline ]
    Selenium concentration measured in each arm compared to each other arm.


Other Outcome Measures:
  • 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.

  • 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.

  • 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.

  • 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.


Enrollment: 150
Study Start Date: November 2012
Study Completion Date: January 2014
Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: 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 Name: 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 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

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01473914


Locations
Canada, Alberta
University of Calgary
Calgary, Alberta, Canada, T2N 1N4
University of Alberta
Edmonton, Alberta, Canada, T6G 2V2
Sponsors and Collaborators
Marcello Tonelli
Alberta Health Services
Investigators
Principal Investigator: Marcello A Tonelli, MD University of Alberta
  More Information

Additional Information:
Publications:
Responsible Party: Marcello Tonelli, MD, Professor, University of Alberta
ClinicalTrials.gov Identifier: NCT01473914     History of Changes
Other Study ID Numbers: TRSV1
First Submitted: September 23, 2011
First Posted: November 17, 2011
Last Update Posted: December 16, 2016
Last Verified: December 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Additional relevant MeSH terms:
Kidney Failure, Chronic
Renal Insufficiency, Chronic
Renal Insufficiency
Kidney Diseases
Urologic Diseases
Vitamins
Vitamin E
Tocopherols
Tocotrienols
alpha-Tocopherol
Zinc
Selenium
Trace Elements
Micronutrients
Growth Substances
Physiological Effects of Drugs
Antioxidants
Molecular Mechanisms of Pharmacological Action
Protective Agents