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

Hamedi‐Kalajahi 2021.

Study characteristics
Methods Study characteristics
  • Study design: parallel RCT

  • Study duration: August 2019 to October 2019

  • Study follow‐up: 10 weeks

Participants Baseline characteristics
  • Country: Iran

  • Setting: Children’s Hospital and University Hospital (2 sites)

  • Inclusion criteria: CKD patients aged 6 to 18 years; at least 2 dialysis sessions/week; HD for at least 3 months

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

  • Dialysis modality: HD

  • Mean age ± SD (years): intervention group (12.92 ± 4.17); control group (13.25 ± 3.11)

  • Sex (M/F): intervention group (10/5); control group (9/6)

  • Dialysis duration: not reported

  • Exclusion criteria: pregnancy; autoimmune, infectious, and cardiovascular disease; thyroid disorders; thrombocytopenia; nutritional support (central and parental nutrition)

Interventions Intervention group
  • L‐carnitine (oral): 50 mg/kg/day for 10 weeks


Control group
  • Placebo

Outcomes Outcomes relevant to this review
  • QoL (PedsQL)

Notes
  • Funding source: the Faculty of Nutrition and Dietetics, Tehran University of Medical Sciences

Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk Quote: "based on random assignment in SPSS"
Allocation concealment (selection bias) Low risk Quote: "sealed and uniform envelopes were then elicited by an independent coworker"
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
Incomplete outcome data (attrition bias)
QoL Low risk Missing outcome data balanced in numbers across intervention groups.
Selective reporting (reporting bias) Low risk All expected outcomes were reported
Other bias Low risk Funding source: the Faculty of Nutrition and Dietetics, Tehran University of Medical Sciences