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

Arduini 2006.

Study characteristics
Methods Study characteristics
  • Study design: parallel RCT

  • Study duration: not reported

  • Study follow‐up: 24 weeks

Participants Baseline characteristics
  • Country: UK

  • Setting: not reported

  • Inclusion criteria: stable HD patients with secondary carnitine deficiency

  • Randomised number (intervention/control): 14/15

  • Dialysis modality: HD

  • Mean age ± SD (years): not reported

  • Sex (M/F): not reported

  • Mean dialysis duration ± SD (years): not reported

  • Exclusion criteria: Hb < 8 g/dL in past 2 months; change in rHuEPO dose in previous 4 weeks; serum ferritin < 200mg/L; URR < 65%; PTH > 60 pmol/L; BP > 160/105 mm Hg; bodyweight > 100 kg; presence of an infection, malignancy, or extrarenal cause of anaemia

Interventions Intervention group
  • L‐carnitine (IV): 20 mg/kg at each dialysis session for 24 weeks


Control group
  • Placebo

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

  • Intradialytic hypotension

Notes Funding source: not clearly reported, but the first author is the Director of the Research and Development Department of Iperboreal Pharma Srl
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)
Muscle symptoms 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)
Myocardial function Low risk Quote: "double‐blind placebo‐controlled" study
Incomplete outcome data (attrition bias)
Muscle symptoms Low risk Missing outcome data balanced in numbers across intervention groups
Quote: "Two placebo patients withdrew (one underwent transplantation, one due to abdominal pain), and one LC patient receiving a blood transfusion was excluded from the analysis."
Incomplete outcome data (attrition bias)
Anaemia‐related markers Low risk Missing outcome data balanced in numbers across intervention groups
Quote: "Two placebo patients withdrew (one underwent transplantation, one due to abdominal pain), and one LC patient receiving a blood transfusion was excluded from the analysis."
Incomplete outcome data (attrition bias)
Myocardial function Low risk Missing outcome data balanced in numbers across intervention groups
Quote: "Two placebo patients withdrew (one underwent transplantation, one due to abdominal pain), and one LC patient receiving a blood transfusion was excluded from the analysis."
Selective reporting (reporting bias) Unclear risk The study protocol is not available
Other bias High risk Funding source: not clearly reported, but the first author is the Director of the Research and Development Department of Iperboreal Pharma Srl