Trace Element Replenishment Study in Hemodialysis Patients

End Stage Renal Disease Clinical Trial

Official title:

Trace Element Replenishment Study in Hemodialysis Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01473914
• Other study ID #: TRSV1
• Status: Completed
• Phase: Phase 3
• First received: September 23, 2011
• Last updated: December 14, 2016
• Start date: November 2012
• Est. completion date: January 2014

Study information

• Verified date: December 2016
• Source: University of Alberta
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Health Canada
• Study type: Interventional

Clinical Trial Summary

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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 150
• Est. completion date: January 2014
• Est. primary completion date: December 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• End Stage Renal Disease
• Kidney Failure, Chronic

Intervention

Dietary Supplement:
• Low dose: supplemental zinc, selenium and vitamin E
ZINC 25mg (AS ZINC SULFATE) SELENIUM 50 mcg (AS SODIUM SELENITE) VITAMIN E (D-ALPHA-TOCOPHEROL) (AS SUCCINATE) 250 IU
• Standard renal vitamin: B and C renal vitamin
BIOTIN 300 MCG D-PANTOTHENIC ACID (CALCIUM D-PANTOTHENATE) 10 MG FOLIC ACID 1 MG NIACINAMIDE 20 MG VITAMIN B1 (THIAMINE MONONITRATE) 1.5 MG VITAMIN B12(CYANOCOBALAMIN) 6 MCG VITAMIN B2 (RIBOFLAVIN) 1.7 MG VITAMIN B6 (PYRIDOXINE HYDROCHLORIDE) 10 MG VITAMIN C (ASCORBIC ACID) 100 MG INERT FILLER (CORNSTARCH)
• Medium dose: supplemental zinc, selenium and vitamin E
ZINC 50 mg (AS ZINC SULFATE) SELENIUM 75 mcg (AS SODIUM SELENITE) VITAMIN E (D-ALPHA-TOCOPHEROL) (AS SUCCINATE) 250 IU

Locations

Country	Name	City	State
Canada	University of Calgary	Calgary	Alberta
Canada	University of Alberta	Edmonton	Alberta

Sponsors (2)

Lead Sponsor	Collaborator
Marcello Tonelli	Alberta Health Services

Country where clinical trial is conducted

Canada, 

References & Publications (1)

Tonelli M, Wiebe N, Thompson S, Kinniburgh D, Klarenbach SW, Walsh M, Bello AK, Faruque L, Field C, Manns BJ, Hemmelgarn BR; Alberta Kidney Disease Network.. Trace element supplementation in hemodialysis patients: a randomized controlled trial. BMC Nephro — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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.	30 days following last day of intervention	Yes
Other	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.	30 days following last day of intervention	Yes
Other	Change in interdialytic weight	Change in interdialytic weight in each arm compared to each other arm.	90 days and 180 days following baseline	No
Other	Salt sensitivity	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	No
Primary	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.	90 days following baseline	No
Secondary	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.	180 days following baseline	No
Secondary	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.	90 days and 180 days following baseline	No
Secondary	Zinc	Zinc concentration in each arm compared to each other arm.	90 days and 180 days following baseline	No
Secondary	Selenium	Selenium concentration measured in each arm compared to each other arm.	90 days and 180 days following baseline	No

External Links

•   Published open access article with final results