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. 2022 Dec 6;2022(12):CD013601. doi: 10.1002/14651858.CD013601.pub2

Bonomini 2006.

Study characteristics
Methods Study characteristics
  • Study design: parallel RCT

  • Study duration: not reported

  • Study follow‐up: 24 weeks

Participants Baseline characteristics
  • Country: Italy

  • Setting: dialysis centres (52 sites)

  • Inclusion criteria: HD patients with left ventricular hypertrophy

  • Number randomised (intervention 1/intervention 2/control): 106/117/107

  • Dialysis modality: HD

  • Mean age ± SD (years): not reported

  • Sex (M/F): not reported

  • Dialysis duration: not reported

  • Exclusion criteria: unclear

Interventions Intervention group 1
  • L‐carnitine (IV): 3 mg/kg at each dialysis session for 24 weeks


Intervention group 2
  • L‐carnitine (IV): 6 mg/kg at each dialysis session for 24 weeks


Control group
  • Placebo

Outcomes Outcomes relevant to this review
  • Fatigue score: fatigue domain of KDQ

  • Other domains of the KDQ including frustration, depression, relationship, and total score

Notes Other information
  • Abstract‐only publication

  • Funding source: Grant/Research Support: Sigma‐Tau S.p.A.; Other: One of the authors is an employee of Sigma‐Tau S.p.A.

Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Unclear risk Study was described as randomised; method of randomisation was not reported
Allocation concealment (selection bias) Unclear risk Insufficient information to permit judgement
Blinding of participants and personnel (performance bias) Low risk Quote: "double‐blind placebo‐controlled" study
Blinding of outcome assessment (detection bias)
QoL Low risk Quote: "double‐blind placebo‐controlled" study
Blinding of outcome assessment (detection bias)
Fatigue score Low risk Quote: "double‐blind placebo‐controlled" study
Incomplete outcome data (attrition bias)
QoL Unclear risk Quote: "Thirty‐one patients dropped out, mainly due to kidney transplantation (N=13) or informed consent withdrawal (N=10)."
Insufficient information to permit judgement
Incomplete outcome data (attrition bias)
Fatigue score Unclear risk Quote: "Thirty‐one patients dropped out, mainly due to kidney transplantation (N=13) or informed consent withdrawal (N=10)."
Insufficient information to permit judgement
Selective reporting (reporting bias) Unclear risk Insufficient information to permit judgement
Other bias High risk Funding source: Grant/Research Support: Sigma‐Tau S.p.A.; Other: Sigma‐Tau S.p.A.; R. Camerini is an employee of Sigma‐Tau S.p.A.