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

Caruso 1998.

Study characteristics
Methods Study characteristics
  • Study design: parallel RCT

  • Study duration: not reported

  • Study follow‐up: 9 months

Participants Baseline characteristics
  • Country: Italy

  • Setting: dialysis centre (1 site)

  • Inclusion criteria: > 40 years; dialytic age > 1 year; rHuEPO therapy > 9 months; HCT 30% to 35%; normal iron status

  • Randomised number (intervention/control): 15/16

  • Dialysis modality: HD

  • Mean age ± SD (years): intervention group (67.6 ± 13.43); control group (65.69 ± 14.54)

  • Sex (M/F): intervention group (11/4); control group (5/11)

  • Mean dialysis duration ± SD (years): intervention group (3.73 ± 2.49); control group (5.56 ± 4.38)

  • Exclusion criteria: L‐carnitine intervention within 2 months; severe hyperparathyroidism (PTH > 150); signs of aluminium intoxication; uncontrolled hypertension; severe liver disease; causes of anaemia other than uremia; pregnancy

Interventions Intervention group
  • L‐carnitine (IV): 1000 mg at each dialysis session for 6 months


Control group
  • Placebo

Outcomes Outcomes relevant to this review
  • Anaemia‐related markers: Hb, EPO dose

  • Death: any cause; cardiac

Notes Funding source: not mentioned, but an author was from the Sigma Tau company
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Unclear risk Study was described as "according to a randomization list"; 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)
Anaemia‐related markers Low risk Quote: "double‐blind placebo‐controlled" study
Blinding of outcome assessment (detection bias)
Death Low risk Quote: "double‐blind placebo‐controlled" study
Incomplete outcome data (attrition bias)
Anaemia‐related markers Low risk Missing outcome data balanced in numbers across intervention groups
Incomplete outcome data (attrition bias)
Death Low risk No missing outcome data
Selective reporting (reporting bias) Unclear risk The study protocol is not available
Other bias High risk Funding source: not mentioned, but an author was from the Sigma Tau company