Trace Element Replenishment Study in Hemodialysis Patients

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
AHS Cancer Control Alberta
Information provided by (Responsible Party):
Marcello Tonelli, University of Alberta
ClinicalTrials.gov Identifier:
NCT01473914
First received: September 23, 2011
Last updated: July 5, 2013
Last verified: July 2013

September 23, 2011
July 5, 2013
November 2012
December 2013   (final data collection date for primary outcome measure)
Proportion of participants with zinc deficiency [ Time Frame: 90 days following baseline ] [ Designated as safety issue: No ]
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.
  • 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: 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: 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.
Complete list of historical versions of study NCT01473914 on ClinicalTrials.gov Archive Site
  • Proportion of participants with zinc deficiency [ Time Frame: 180 days following baseline ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    Zinc concentration in each arm compared to each other arm.
  • Selenium [ Time Frame: 90 days and 180 days following baseline ] [ Designated as safety issue: No ]
    Selenium concentration measured in each arm compared to each other arm.
  • 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 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 during last week of study treatment (the week prior to day 180).
  • 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 day 30, 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.
  • Proportions of participants with serious adverse events [ Time Frame: 30 days following last day of intervention ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: No ]
    Change in interdialytic weight in each arm compared to each other arm.
  • Salt sensitivity [ Time Frame: 90 days and 180 days following baseline ] [ Designated as safety issue: No ]
    The proportion of participants with recognized and detect salt sensitivities in each arm compared to each other arm.
Not Provided
 
Trace Element Replenishment Study in Hemodialysis Patients
Trace Element Replenishment Study in Hemodialysis Patients

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

Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
End Stage Renal Disease
  • 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
  • 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
  • Experimental: Low dose

    Standard renal vitamin plus low dose zinc and selenium plus vitamin E

    1 capsule p.o, daily

    Interventions:
    • Dietary Supplement: Low dose: supplemental zinc, selenium and vitamin E
    • Dietary Supplement: Standard renal vitamin: B and C renal vitamin
  • Experimental: Medium dose

    Standard renal vitamin plus medium doses of zinc and selenium plus vitamin E

    1 capsule p.o, daily

    Interventions:
    • Dietary Supplement: Standard renal vitamin: B and C renal vitamin
    • Dietary Supplement: Medium dose: supplemental zinc, selenium and vitamin E
  • Active Comparator: Standard treatment

    Standard renal vitamin

    1 capsule p.o, daily

    Intervention: Dietary Supplement: Standard renal vitamin: B and C renal vitamin
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
150
January 2014
December 2013   (final data collection date for primary outcome measure)

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.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Canada
 
NCT01473914
TRSV1
No
Marcello Tonelli, University of Alberta
Marcello Tonelli
AHS Cancer Control Alberta
Principal Investigator: Marcello A Tonelli, MD University of Alberta
University of Alberta
July 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP