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Effects of nutritional supplementation on fatigue, and autonomic and immune dysfunction in patients with end-stage renal disease: a randomized, double-blind, placebo-controlled, multicenter trial.

Fukuda S, Koyama H, Kondo K, Fujii H, Hirayama Y, Tabata T, Okamura M, Yamakawa T, Okada S, Hirata S, Kiyama H, Kajimoto O, Watanabe Y, Inaba M, Nishizawa Y - PLoS ONE (2015)

Bottom Line: Several parameters of heart rate variability significantly increased after nutritional treatment compared to placebo.Nutritional drink for 12 weeks significantly suppressed HHV7 DNA copy numbers.Similarly, HHV6 DNA copy numbers tended to be decreased by treatment but without reaching statistical significance.

View Article: PubMed Central - PubMed

Affiliation: University of Welfare Sciences, Kasiwara, Osaka, 582-0026, Japan; RIKEN Center for Life Science Technologies, Kobe, Hyogo, 650-0047, Japan; Department of Physiology, Osaka City University Graduate School of Medicine, Osaka, 545-8585, Japan.

ABSTRACT

Background: Fatigue is a predictor of cardiovascular events in patients with end-stage renal disease (ESRD) undergoing hemodialysis treatment. We hypothesized that multinutritional support would improve quality of life, fatigue symptoms, and potential quantitative measures including endocrine, immune and autonomic functions in patients with ESRD undergoing hemodialysis.

Methods: Two hundred and two hemodialysis patients were randomly assigned to receive active treatment (containing vitamin B1, vitamin B2, niacin, vitamin B6, vitamin B12, folic acid, vitamin C, carnitine, coenzyme Q10, naïve galacto-oligosaccharide, and zinc) or placebo after each dialysis session for 12 weeks. The patients and attending physicians were blinded to the treatment, and 172 patients (86 in each group) completed the study. Fatigue was evaluated via fatigue questionnaire at 0, 4, and 12 weeks. To assess human herpes virus (HHV) 6 and 7 reactivation, numbers of viral DNA copies were determined in saliva by polymerase chain reaction at weeks 0 and 12. Autonomic function was determined via measurement of beat-to-beat variation by using acceleration plethysmography.

Results: Clinical characteristics, changes in fatigue, quality of life score, endocrine functions, and laboratory data did not differ significantly between the two groups. Several parameters of heart rate variability significantly increased after nutritional treatment compared to placebo. Nutritional drink for 12 weeks significantly suppressed HHV7 DNA copy numbers. Similarly, HHV6 DNA copy numbers tended to be decreased by treatment but without reaching statistical significance.

Conclusions: Nutritional supplementation may modulate immune and autonomic dysfunction in ESRD patients undergoing hemodialysis.

No MeSH data available.


Related in: MedlinePlus

Flowchart of enrollment of randomized control study.
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pone.0119578.g001: Flowchart of enrollment of randomized control study.

Mentions: Fig. 1 shows participant flow from screening to last assessment. A total of 203 participants were assessed for eligibility. One participant withdrew consent before the randomization and a total of 202 patients [Inoue Hospital, Suita, Japan (n = 72); Ohno Memorial Hospital, Osaka, Japan (n = 54); Okada Clinic, Osaka, Japan (n = 31); Shirasagi Hospital, Osaka, Japan (n = 46)] were included in the trial and were randomly assigned to one of the two treatment arms. Of the 202 participants, six in the nutritional drink group and two in the placebo group did not receive allocation. Four participants in the nutritional group and two in the placebo group did not receive allocation because they withdrew consent. Two participants in the nutritional drink group did not receive allocation because of hospitalization or changing the time of dialysis from afternoon to morning. Ten participants in each group discontinued intervention (in the nutritional group, 4 withdrew consent and 6 experienced adverse effects; in the placebo group, 1 withdrew consent, 1 was hospitalized, 5 experienced adverse effects, 2 changed the time of dialysis from afternoon to morning, and 1 had unknown reasons). Finally, 68 patients in Inoue Hospital, 43 in Ohno Memorial Hospital, 24 in Okada Clinic, and 39 in Shirasagi hospital completed the intervention. One patient was excluded from the final analysis because of changing the hospital visit date from a weekday to the weekend. Originally assigned code numbers for intervention allocation were open after participants for analysis were finalized.


Effects of nutritional supplementation on fatigue, and autonomic and immune dysfunction in patients with end-stage renal disease: a randomized, double-blind, placebo-controlled, multicenter trial.

Fukuda S, Koyama H, Kondo K, Fujii H, Hirayama Y, Tabata T, Okamura M, Yamakawa T, Okada S, Hirata S, Kiyama H, Kajimoto O, Watanabe Y, Inaba M, Nishizawa Y - PLoS ONE (2015)

Flowchart of enrollment of randomized control study.
© Copyright Policy
Related In: Results  -  Collection

License
Show All Figures
getmorefigures.php?uid=PMC4352065&req=5

pone.0119578.g001: Flowchart of enrollment of randomized control study.
Mentions: Fig. 1 shows participant flow from screening to last assessment. A total of 203 participants were assessed for eligibility. One participant withdrew consent before the randomization and a total of 202 patients [Inoue Hospital, Suita, Japan (n = 72); Ohno Memorial Hospital, Osaka, Japan (n = 54); Okada Clinic, Osaka, Japan (n = 31); Shirasagi Hospital, Osaka, Japan (n = 46)] were included in the trial and were randomly assigned to one of the two treatment arms. Of the 202 participants, six in the nutritional drink group and two in the placebo group did not receive allocation. Four participants in the nutritional group and two in the placebo group did not receive allocation because they withdrew consent. Two participants in the nutritional drink group did not receive allocation because of hospitalization or changing the time of dialysis from afternoon to morning. Ten participants in each group discontinued intervention (in the nutritional group, 4 withdrew consent and 6 experienced adverse effects; in the placebo group, 1 withdrew consent, 1 was hospitalized, 5 experienced adverse effects, 2 changed the time of dialysis from afternoon to morning, and 1 had unknown reasons). Finally, 68 patients in Inoue Hospital, 43 in Ohno Memorial Hospital, 24 in Okada Clinic, and 39 in Shirasagi hospital completed the intervention. One patient was excluded from the final analysis because of changing the hospital visit date from a weekday to the weekend. Originally assigned code numbers for intervention allocation were open after participants for analysis were finalized.

Bottom Line: Several parameters of heart rate variability significantly increased after nutritional treatment compared to placebo.Nutritional drink for 12 weeks significantly suppressed HHV7 DNA copy numbers.Similarly, HHV6 DNA copy numbers tended to be decreased by treatment but without reaching statistical significance.

View Article: PubMed Central - PubMed

Affiliation: University of Welfare Sciences, Kasiwara, Osaka, 582-0026, Japan; RIKEN Center for Life Science Technologies, Kobe, Hyogo, 650-0047, Japan; Department of Physiology, Osaka City University Graduate School of Medicine, Osaka, 545-8585, Japan.

ABSTRACT

Background: Fatigue is a predictor of cardiovascular events in patients with end-stage renal disease (ESRD) undergoing hemodialysis treatment. We hypothesized that multinutritional support would improve quality of life, fatigue symptoms, and potential quantitative measures including endocrine, immune and autonomic functions in patients with ESRD undergoing hemodialysis.

Methods: Two hundred and two hemodialysis patients were randomly assigned to receive active treatment (containing vitamin B1, vitamin B2, niacin, vitamin B6, vitamin B12, folic acid, vitamin C, carnitine, coenzyme Q10, naïve galacto-oligosaccharide, and zinc) or placebo after each dialysis session for 12 weeks. The patients and attending physicians were blinded to the treatment, and 172 patients (86 in each group) completed the study. Fatigue was evaluated via fatigue questionnaire at 0, 4, and 12 weeks. To assess human herpes virus (HHV) 6 and 7 reactivation, numbers of viral DNA copies were determined in saliva by polymerase chain reaction at weeks 0 and 12. Autonomic function was determined via measurement of beat-to-beat variation by using acceleration plethysmography.

Results: Clinical characteristics, changes in fatigue, quality of life score, endocrine functions, and laboratory data did not differ significantly between the two groups. Several parameters of heart rate variability significantly increased after nutritional treatment compared to placebo. Nutritional drink for 12 weeks significantly suppressed HHV7 DNA copy numbers. Similarly, HHV6 DNA copy numbers tended to be decreased by treatment but without reaching statistical significance.

Conclusions: Nutritional supplementation may modulate immune and autonomic dysfunction in ESRD patients undergoing hemodialysis.

No MeSH data available.


Related in: MedlinePlus