Evidence map›Paper›PMID 25746727›Full record

Trial reportPloS one2015

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.

Sanae Fukuda, Hidenori Koyama, Kazuhiro Kondo, Hisako Fujii, Yoshinobu Hirayama, Tsutomu Tabata, Mikio Okamura, Tomoyuki Yamakawa, Shigeki Okada, Sumio Hirata and 5 more

Open access · goldAbstract readMulticenter StudyRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in PloS one, 2015. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 23 papers, 6 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
23citing papers in PubMed, 6 pooled it
1.7field-weighted citation impact, top 17% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

23 citing papers in PubMed, 6 syntheses or guidelines pooled it, 48 citations in OpenAlex.

  1. Antioxidants for adults with chronic kidney disease.The Cochrane database of systematic reviews · 2023
    Pooled it
  2. Interventions for fatigue in people with kidney failure requiring dialysis.The Cochrane database of systematic reviews · 2023
    Pooled it
  3. Pooled it
  4. Measuring quality of life in trials including patients on haemodialysis: methodological issues surrounding the use of the Kidney Disease Quality of Life Questionnaire.Nephrology, dialysis, transplantation : official publication of the European Dialysis and Transplant Association - European Renal Association · 2022
    Pooled it
  5. Pooled it
  6. Pooled it
  7. Trial
  8. Trial
  9. Effects ofNutrients · 2020
    Trial
  10. Trial
  11. Review
  12. Article
  13. Review
  14. Review
  15. Article
  16. Review
  17. Review
  18. Review
  19. Anti-Tumor Effects of Vitamin B2, B6 and B9 in Promonocytic Lymphoma Cells.International journal of molecular sciences · 2019
    Article
  20. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

15 authors at 9 institutions in 1 country.

Sanae FukudaUniversity 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.
Hidenori KoyamaDepartment of Metabolism, Endocrinology and Molecular Medicine, Osaka City University Graduate School of Medicine, Osaka, 545-8585, Japan; Department of Internal Medicine, Division of Diabetes, Endocrinology and Metabolism, Hyogo College of Medicine, Nishinomiya, Hyogo, 663-8501, Japan.
Kazuhiro KondoDepartment of Virology, The Jikei University School of Medicine, Tokyo, 105-8461, Japan.
Hisako FujiiDepartment of Physiology, Osaka City University Graduate School of Medicine, Osaka, 545-8585, Japan; Center for Drug & Food Clinical Evaluation, Osaka City University Hospital, Osaka, 540-0051, Japan.
Yoshinobu HirayamaCollege of Pharmaceutical Sciences, Ritsumeikan University, Kusatsu, 525-8577, Japan.
Tsutomu TabataInoue Hospital, Suita, 564-0053, Japan.
Mikio OkamuraOhno Memorial Hospital, Osaka, 550-0015, Japan.
Tomoyuki YamakawaShirasagi Hospital, Osaka, 546-0002, Japan.
Shigeki OkadaOkada Clinic, Osaka, 543-0056, Japan.
Sumio HirataKumamoto University School of Pharmacy, Kumamoto, 862-0973, Japan.
Hiroshi KiyamaNagoya University School of Medicine, Nagoya, 466-8550, Japan.
Osami KajimotoDepartment of Medical Science on Fatigue, Osaka City University Graduate School of Medicine, Osaka, 545-8585, Japan.
Yasuyoshi WatanabeRIKEN Center for Life Science Technologies, Kobe, Hyogo, 650-0047, Japan; Department of Physiology, Osaka City University Graduate School of Medicine, Osaka, 545-8585, Japan.
Masaaki InabaDepartment of Metabolism, Endocrinology and Molecular Medicine, Osaka City University Graduate School of Medicine, Osaka, 545-8585, Japan.
Yoshiki NishizawaDepartment of Metabolism, Endocrinology and Molecular Medicine, Osaka City University Graduate School of Medicine, Osaka, 545-8585, Japan.
Osaka City University · JPHyogo Medical University · JPInoue Hospital · JPJikei University School of Medicine · JPKansai University of Welfare Sciences · JPKumamoto University · JPNagoya University · JPRitsumeikan University · JPShirasagi Hospital · JP

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundFatigue 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.

methodsTwo 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.

resultsClinical 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.

conclusionsNutritional supplementation may modulate immune and autonomic dysfunction in ESRD patients undergoing hemodialysis.

Indexed as

Dietary SupplementsAdultAgedDouble-Blind MethodFatigueFemaleHumansKidney Failure, ChronicMaleMiddle AgedPlacebosQuality of LifeRenal DialysisPlacebos

Identifiers

PMID25746727
PMCPMC4352065
OpenAlexW2063801972

What OpenQuestion holds

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LicenceCC BY
Read underepoch 390

Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.