Murray‐Kolb 2007.
Methods |
Design: randomised controlled trial Randomisation: individual Trial: daily oral iron versus placebo Date of study: 1999 to 2002 |
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Participants |
Setting: communities around University Park campus of The Pennsylvania State University in State College in the USA Malaria endemicity: not stated Included: women aged 18 years to 35 years (mean age 21 years) Excluded: chronic illnesses or serious health problems, not speaking English as the primary language at home Dropouts: 39 out of 152 (26% total loss to follow‐up) Sample size: total: 113; intervention: 56, control: 57 |
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Interventions |
Intervention: 160 mg ferrous sulphate containing 60 mg elemental iron Control: placebo Duration: 16 weeks |
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Outcomes | Haemoglobin, iron status, anxiety and psychological scores | |
Notes |
Compliance: 95% (determine by pill count) not divided by iron/placebo group Conflicts of interest: authors declare no conflict of interest Funded by: USDA NRICGP 99‐35200‐7610 and GCRC MO1RR10732 Other notes: cognitive endpoint data reported in figures and without errors, not extractable |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Stratified randomisation performed by using random permuted blocks |
Allocation concealment (selection bias) | Low risk | Bottles coded preventing disclosure of allocated arm |
Blinding of participants and personnel (performance bias) All outcomes | Low risk | Placebo administered |
Blinding of outcome assessment (detection bias) All outcomes | Low risk | Blinded as intervention and control could not be discerned; bottles coded |
Incomplete outcome data (attrition bias) All outcomes | Low risk | 26% loss to follow‐up; 152 enrolled, 113 completed study |
Selective reporting (reporting bias) | High risk | Endpoint data for several key cognitive outcomes not reported in study. Only shown on figures without SE/SD/CIs to enable extraction |
Other bias | Low risk | The study appears free of other sources of bias |