Clinical trial NCT01473914: Trace Element Replenishment Study in Hemodialysis Patients
Official title: Trace Element Replenishment Study in Hemodialysis Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: End Stage Renal Disease
Lead sponsor: University of Alberta
Sponsor class: OTHER
Collaborators: name: Alberta Health services
First posted: 2011-11-17
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

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 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.

Primary outcomes:
measure: Proportion of participants with zinc deficiency
timeFrame: 90 days following baseline
Secondary outcomes:
measure: Proportion of participants with zinc deficiency
timeFrame: 180 days following baseline
measure: Proportion of participants with selenium deficiency
timeFrame: 90 days and 180 days following baseline
measure: Zinc
timeFrame: 90 days and 180 days following baseline
measure: Selenium
timeFrame: 90 days and 180 days following baseline
Other outcomes:
measure: Proportions of participants with serious adverse events
timeFrame: 30 days following last day of intervention
measure: Proportion of participants with adverse events
timeFrame: 30 days following last day of intervention
measure: Change in interdialytic weight
timeFrame: 90 days and 180 days following baseline
measure: Salt sensitivity
timeFrame: 90 days and 180 days following baseline
Locations:
city: Calgary
country: Canada
facility: University of Calgary
state: Alberta
city: Edmonton
country: Canada
facility: University of Alberta
state: Alberta
Study officials:
affiliation: University of Alberta
name: Marcello A Tonelli, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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 Nephrol. 2015 Apr 11;16:52. doi: 10.1186/s12882-015-0042-4.