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

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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.

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Most cited references 27

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Aspects of immune dysfunction in end-stage renal disease.

Sawako Kato, Michal Chmielewski, Hirokazu Honda … (2008)

End-stage renal disease (ESRD) is associated with significantly increased morbidity and mortality resulting from cardiovascular disease (CVD) and infections, accounting for 50% and 20%, respectively, of the total mortality in ESRD patients. It is possible that these two complications are linked to alterations in the immune system in ESRD, as uremia is associated with a state of immune dysfunction characterized by immunodepression that contributes to the high prevalence of infections among these patients, as well as by immunoactivation resulting in inflammation that may contribute to CVD. This review describes disorders of the innate and adaptive immune systems in ESRD, underlining the specific role of ESRD-associated disturbances of Toll-like receptors. Finally, based on the emerging links between the alterations of immune system, CVD, and infections in ESRD patients, it emphasizes the potential role of the immune dysfunction in ESRD as an underlying cause for the high mortality in this patient population and the need for more studies in this area.

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Association among SF36 quality of life measures and nutrition, hospitalization, and mortality in hemodialysis.

H Humphreys, G Block, K. Kalantar-Zadeh … (2001)

Patients on maintenance hemodialysis (MHD) often show substantial reductions in quality of life (QoL). The SF36 (Short Form with 36 questions), a well-documented, self-administered QoL scoring system that includes eight independent scales and two main dimensions, has been widely used and validated. In 65 adult outpatients on MHD, the SF36 and its scales and dimensions, scored as a number between 0 and 100, and the nutritional and inflammatory state measured by subjective global assessment, near-infrared (NIR) body fat, body mass index (BMI), and pertinent laboratory values, including hemoglobin, albumin, and C-reactive protein were assessed. Twelve-month prospective hospitalization rates and mortality were used as the clinical outcomes. Multivariate (case-mix) adjusted correlation coefficients were statistically significant between SF36 scores and serum albumin and hemoglobin concentrations. There were significant inverse correlations between SF36 scores and the BMI and NIR body fat percentage. Hypoalbuminemic, anemic, and obese patients on MHD had a worse QoL. Prospective hospitalizations correlated significantly with the SF36 total score and its two main dimensions (r between -0.28 and -0.40). The Cox proportional regression relative risk of death for each 10 unit decrease in SF36 was 2.07 (95% CI, 1.08 to 3.98; P = 0.02). Of the eight components and two dimensions of the SF36, the Mental Health dimension and the SF36 total score had the strongest predictive value for mortality. Thus, in patients on MHD the SF36 appears to have significant associations with measures of nutritional status, anemia, and clinical outcomes, including prospective hospitalization and mortality. Even though obesity, unlike undernutrition, is not generally an indicator of poor outcome in MHD, the SF36 may detect obese patients on MHD at higher risk for morbidity and mortality.

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Sleep quality predicts quality of life and mortality risk in haemodialysis patients: results from the Dialysis Outcomes and Practice Patterns Study (DOPPS).

Kiyoshi Kurokawa, C K Rayner, Jack S. Elder … (2008)

Poor sleep quality (SQ) affects many haemodialysis (HD) patients and could potentially predict their morbidity, mortality, quality of life (QOL) and patterns of medication use. Data on SQ were collected from 11,351 patients in 308 dialysis units in seven countries in the Dialysis Outcomes and Practice Patterns Study (DOPPS) between 1996 and 2001 through a patient self-reported SQ scale, ranging from 0 (worst) to 10 (best). A score of <6 reflected poor SQ. Sleep disturbance was also assessed by self-reported daytime sleepiness, feeling drained and nocturnal awakening. Logistic and multiple linear regression were used to assess predictors of SQ and associations with QOL. Cox regression examined associations with mortality. Analyses accounted for case-mix, facility clustering and country. Nearly half (49%) of patients experienced poor SQ. Mean SQ scores varied by country, ranging from 4.9 in Germany to 6.5 in Japan. Patients with poor SQ were more likely to be prescribed antihistamines, antidepressants, anti-inflammatories, narcotics, gastrointestinal (GI) medications, anti-asthmatics or hypnotics. Physical exercise at least once a week (vs < once a week) was associated with lower odds of poor SQ (AOR = 0.55-0.85, P < 0.05). Poorer SQ was associated with significantly lower mental and physical component summary (MCS/PCS) scores (MCS scores 1.9-13.2 points lower and PCS scores 1.5-7.7 points lower when SQ scores were <10 vs 10). The RR of mortality was 16% higher for HD patients with poor SQ. Poor SQ is common among HD patients in DOPPS countries and is independently associated with several QOL indices, medication use patterns and mortality. Assessment and management of SQ should be an important component of care.

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Author and article information

Contributors

Mario D. Cordero: Role: Academic Editor

Journal

Journal ID (nlm-ta): PLoS One

Journal ID (iso-abbrev): PLoS ONE

Journal ID (publisher-id): plos

Journal ID (pmc): plosone

Title: PLoS ONE

Publisher: Public Library of Science (San Francisco, CA USA )

ISSN (Electronic): 1932-6203

Publication date (Electronic): 6 March 2015

Publication date Collection: 2015

Volume: 10

Issue: 3

Electronic Location Identifier: e0119578

Affiliations

[1 ]University of Welfare Sciences, Kasiwara, Osaka, 582-0026, Japan

[2 ]RIKEN Center for Life Science Technologies, Kobe, Hyogo, 650-0047, Japan

[3 ]Department of Physiology, Osaka City University Graduate School of Medicine, Osaka, 545-8585, Japan

[4 ]Department of Metabolism, Endocrinology and Molecular Medicine, Osaka City University Graduate School of Medicine, Osaka, 545-8585, Japan

[5 ]Department of Internal Medicine, Division of Diabetes, Endocrinology and Metabolism, Hyogo College of Medicine, Nishinomiya, Hyogo, 663-8501, Japan

[6 ]Department of Virology, The Jikei University School of Medicine, Tokyo, 105-8461, Japan

[7 ]Center for Drug & Food Clinical Evaluation, Osaka City University Hospital, Osaka, 540-0051, Japan

[8 ]College of Pharmaceutical Sciences, Ritsumeikan University, Kusatsu, 525-8577, Japan

[9 ]Inoue Hospital, Suita, 564-0053, Japan

[10 ]Ohno Memorial Hospital, Osaka, 550-0015, Japan

[11 ]Shirasagi Hospital, Osaka, 546-0002, Japan

[12 ]Okada Clinic, Osaka, 543-0056, Japan

[13 ]Kumamoto University School of Pharmacy, Kumamoto, 862-0973, Japan

[14 ]Nagoya University School of Medicine, Nagoya, 466-8550, Japan

[15 ]Department of Medical Science on Fatigue, Osaka City University Graduate School of Medicine, Osaka, 545-8585, Japan

University of Sevilla, SPAIN

Author notes

Competing Interests: Nutritional drink and placebo products were prepared by the Asahi Kasei Kuraray Medical Corporation. Other authors declare no conflict of interests. This does not alter our adherence to PLOS ONE policies on sharing data and materials.

Conceived and designed the experiments: SF HK HF OK YH YW MI YN. Performed the experiments: SF HK HF TT MO TY SO. Analyzed the data: SF HK HF. Contributed reagents/materials/analysis tools: KK SH HK. Wrote the paper: SF HK HF KK.

* E-mail: hkoyama@ 123456hyo-med.ac.jp

Article

Publisher ID: PONE-D-14-02826

DOI: 10.1371/journal.pone.0119578

PMC ID: 4352065

PubMed ID: 25746727

SO-VID: 9ecff3ce-df2f-426a-a189-da9cd37b8969

License:

This is an open access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited

History

Date received : 2 March 2014

Date accepted : 30 January 2015

Page count

Figures: 3, Tables: 3, Pages: 15

Funding

This study was partly supported by grants from the Asahi Kasei Kuraray Medical Cooperation, 21st Century COE Program and Grant-in Aid for Scientific Research (C) (KAKENHI-24500826) by Ministry of Education, Culture, Sports, Science and Technology (Japan), and grants from Health Labour Sciences Research Grant (Comprehensive Research on Disability Health and Welfare [24163001]), Japan. Tsutomo Tabata, Mikio Okamura, Tomoyuki Yamanaka, Shigeki Okada, Sumio Hirata, Yasuyoshi Watanabe and Yosiki Nishizawa received research grants from the Asahi Kasei Kuraray Medical Cooperation, but the sponsors were not involved in the design, execution, analysis, or reporting of the results of this study.

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

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Abstract

Background

Methods

Results

Conclusions

Related collections

PLOS Climate

Most cited references 27

Aspects of immune dysfunction in end-stage renal disease.

Association among SF36 quality of life measures and nutrition, hospitalization, and mortality in hemodialysis.

Sleep quality predicts quality of life and mortality risk in haemodialysis patients: results from the Dialysis Outcomes and Practice Patterns Study (DOPPS).

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