Jacobson 2000Low.
Methods | Randomised, double‐blind, placebo‐controlled trial with parallel group design (two intervention groups). | |
Participants | Country: United States of America. Number of participants randomised: 121, mean age 42, 58% males. Inclusion criteria: adults 18 years of age and older who smoked one or more packs of cigarettes per day and were not currently taking the study vitamins. Exclusion criteria: nondetectable polycyclic aromatic hydrocarbon PAH‐DNA adduct levels in mononuclear cells and plasma vitamin levels higher than 1.0 mg/dl for vitamin C, 15 mg/dl for beta‐carotene, and 1.2 mg/dl for alpha‐tocopherol at the first study visit. |
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Interventions | Participants were randomly assigned to receive: group 1: vitamin C 500 mg, alpha‐tocopherol 400 IU, beta‐carotene 6 mg (n = 60); group 2: placebo (n = 61). Participants were supplemented and followed 0.5 years. |
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Outcomes | The primary outcome measure was: DNA damage. | |
Notes | Compliance with treatment was not reported. Seventy‐three participants completed the trial. Drop‐out rates were high in both groups, but were higher in the placebo (53%) than in the treatment (35%) group. Additional information received through personal communication with the authors. |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Sequence generation was achieved using computer random number generation. |
Allocation concealment (selection bias) | Low risk | Allocation was controlled by a central and independent randomisation unit, so that intervention allocations could not have been foreseen in advance of, or during, enrolment. |
Blinding (performance bias and detection bias) All outcomes | Low risk | The trial was described as blinded, the parties that were blinded, and the method of blinding was described, so that knowledge of allocation was adequately prevented during the trial. |
Incomplete outcome data (attrition bias) All outcomes | Low risk | The numbers and reasons for dropouts and withdrawals in all intervention groups were described. |
Selective reporting (reporting bias) | Low risk | Pre‐defined, or clinically relevant and reasonably expected outcomes are reported on. |
Other bias | Low risk | The trial appears to be free of other components that could put it at risk of bias. |