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

CARNIDIAL 2012.

Study characteristics
Methods Study characteristics
  • Study design: parallel RCT

  • Study duration: October 2006 to March 2010

  • Study follow‐up: 1 year

Participants Baseline characteristics
  • Country: France

  • Setting: public hospital (1 site)

  • Inclusion criteria: started long‐term HD < 6 months before the study started or afterwards; > 18 years

  • Randomised number (intervention/control): 46/46

  • Dialysis modality: HD

  • Mean age ± SD (years): intervention group (61 ± 18); control group (61 ± 15)

  • Sex (M/F): not reported

  • Mean dialysis duration ± SD (days): intervention group (38 ± 25); control group (40 ± 29)

  • Exclusion criteria: pregnancy; cancer; expected life expectancy < 6 months; documented carnitine deficiency

Interventions Intervention group
  • L‐carnitine (IV): 1000 mg at each dialysis session for 1 year


Control group
  • Placebo

Outcomes Outcomes relevant to this review
  • QoL: SF‐36

  • Adverse events

  • Anaemia‐related markers: EPO resistance index

  • Death (any cause)

Notes Other information
  • Funding source: supported by a grant from the French Ministry of Health: CIRC 2005, P050316

  • The first author received honoraria from Gambro and Hoffmann‐La‐Roche in 2010

Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk Quote: "randomly assigned in a 1:1 ratio with a centralized randomization list stratified according to center"
Allocation concealment (selection bias) Low risk Quote: "randomly assigned in a 1:1 ratio with a centralized randomization list stratified according to center"
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)
Adverse events 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)
QoL Unclear risk Insufficient information to permit judgement
Incomplete outcome data (attrition bias)
Adverse events Low risk All patient outcome data reported
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 All patient outcome data reported
Selective reporting (reporting bias) Low risk Pre‐specified outcomes (of interest to this review) were reported
Other bias High risk Funding source: supported by a grant from the French Ministry of Health, but Sigma‐Tau provided L‐carnitine and placebo without charge