Flink 2006.
Methods |
Design: randomised controlled trial Randomisation: individual Trial: daily oral iron versus placebo Date of study: not stated |
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Participants |
Setting: patients attending public dental clinic in Sala, Sweden Malaria endemicity: not stated. Included: unstimulated salivary flow rate of < 0.2 ml/min; ferritin > 10 ng/mL and < 30 mg/mL (females), < 50 mg/mL (males). Of 50 participants recruited, 46 were female. Age range 16 years to 46 years (mean age 34 years) Excluded: not stated Dropouts: 3 of 50 participants failed to complete trial (group unstated) Sample size: total: 47; intervention: 24, control: 23 |
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Interventions |
Intervention: elemental iron (approximately 40 mg) as ferrous fumarate daily Control: placebo Duration: 3 months |
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Outcomes | Iron status | |
Notes |
Compliance: mean compliance during the intervention period was 82% (95% CI 76 to 90) for the placebo group and 71% (95% CI 61 to 82) for the iron group (i.e. resulting in an average daily dose of 85 mg of iron). There was no significant difference in compliance between intervention compared to control groups Conflicts of interest: not stated Funded by: grants from Vastmanland County, Sweden, the Swedish Patent Revenue Research Fund and the Swedish Dental Society |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Computer random number generator |
Allocation concealment (selection bias) | Low risk | Identical containers, identity in numbered envelopes and not revealed until end of study |
Blinding of participants and personnel (performance bias) All outcomes | Low risk | Placebo administered |
Blinding of outcome assessment (detection bias) All outcomes | Low risk | Not reported. However, biochemical measures unlikely to be affected by knowledge of allocation |
Incomplete outcome data (attrition bias) All outcomes | Low risk | Loss to follow‐up: 1 in iron arm, 2 in placebo arm |
Selective reporting (reporting bias) | Low risk | Not evident |
Other bias | Low risk | Not evident |