Skip to main content
. 2016 Apr 18;2016(4):CD009747. doi: 10.1002/14651858.CD009747.pub2

Flink 2006.

Methods Design: randomised controlled trial
Randomisation: individual
Trial: daily oral iron versus placebo
Date of study: not stated
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
Interventions Intervention: elemental iron (approximately 40 mg) as ferrous fumarate daily
Control: placebo
Duration: 3 months
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
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