Trace element supplementation in hemodialysis patients: a randomized controlled trial

Marcello Tonelli, Natasha Wiebe, Stephanie Thompson, David Kinniburgh, Scott W Klarenbach, Michael Walsh, Aminu K Bello, Labib Faruque, Catherine Field, Braden J Manns, Brenda R Hemmelgarn, Alberta Kidney Disease Network, Marcello Tonelli, Natasha Wiebe, Stephanie Thompson, David Kinniburgh, Scott W Klarenbach, Michael Walsh, Aminu K Bello, Labib Faruque, Catherine Field, Braden J Manns, Brenda R Hemmelgarn, Alberta Kidney Disease Network

Abstract

Background: People with kidney failure are often deficient in zinc and selenium, but little is known about the optimal way to correct such deficiency.

Methods: We did a double-blind randomized trial evaluating the effects of zinc (Zn), selenium (Se) and vitamin E added to the standard oral renal vitamin supplement (B and C vitamins) among hemodialysis patients in Alberta, Canada. We evaluated the effect of two daily doses of the new supplement (medium dose: 50 mg Zn, 75 mcg Se, 250 IU vitamin E; low dose: 25 mg Zn, 50 mcg Se, 250 IU vitamin E) compared to the standard supplement on blood concentrations of Se and Zn at 90 days (primary outcome) and 180 days (secondary outcome) as well as safety outcomes.

Results: We enrolled 150 participants. The proportion of participants with low zinc status (blood level <815 ug/L) did not differ between the control group and the two intervention groups at 90 days (control 23.9% vs combined intervention groups 23.9%, P > 0.99) or 180 days (18.6% vs 28.2%, P = 0.24). The proportion with low selenium status (blood level <121 ug/L) was similar for controls and the combined intervention groups at 90 days (32.6 vs 19.6%, P = 0.09) and 180 days (34.9% vs 23.5%, P = 0.17). There were no significant differences in the risk of adverse events between the groups.

Conclusions: Supplementation with low or medium doses of zinc and selenium did not correct low zinc or selenium status in hemodialysis patients. Future studies should consider higher doses of zinc (≥75 mg/d) and selenium (≥100 mcg/d) with the standard supplement.

Trial registration: Registered with ClinicalTrials.gov (NCT01473914).

Figures

Figure 1
Figure 1
Participant flow diagram. All participants who received at least one dose of the trial intervention were included in the intention-to-treat primary analysis (51 in the medium dose group, 47 in the low dose group, and 49 in the standard dose group). *Participants may have more than one reason for ineligibility.
Figure 2
Figure 2
Zinc and selenium by timepoint. The left panels show the proportion of participants with low zinc status in the upper left panel and the mean serum zinc concentration of the participants in the lower left panel. The right panels show the proportion of participants with low selenium status in the upper right panel and the mean serum selenium concentration of the participants in the lower right panel. The lower panels have black horizontal lines depicting the thresholds of low element status (serum zinc

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