Charoenlarp 1988.
Methods |
Design: two randomised controlled trials Randomisation: individual Trial: Trial 1: daily iron at 2 different doses with and without supervision versus placebo. Trial 2: daily iron at two different doses with and without folic acid versus placebo Date of study: Trial 1: 1977 to 1979, Trial 2: 1978 to 1980 TWO STUDIES:
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Participants |
Setting: Trial 1: Rural area of Central Thailand 80 km north of Bangkok near Ayudhya. Trial 2: Northern Thailand; two villages 50 km south and 100 km south west of Chiang Mai Malaria endemicity: malaria is endemic to both trials Included: women of fertile age Trial 1: age range 15 years to 45 years (mean age not stated) Trial 2: age range 16 years to 45 years (mean age not stated) Excluded: Haemoglobin < 80, thalassaemia trait or disease, uncooperative Dropouts: Trial 1: 16% across all groups (reported as similar), Trial 2: reported at 36%, group status unclear Sample size: total: 863; intervention: 690, control: 173 |
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Interventions |
Intervention:
Control: placebo Duration: 3 months |
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Outcomes | Anaemia, haemoglobin, iron status | |
Notes |
Compliance: not stated Conflicts of interest: not stated. Funded by: World Health Organization (WHO), Belgian administration of co‐operation to development, Danish International Development Authority, and Swedish International Development Authority |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | Not stated |
Allocation concealment (selection bias) | Unclear risk | Not stated |
Blinding of participants and personnel (performance bias) All outcomes | Low risk | Placebo used |
Blinding of outcome assessment (detection bias) All outcomes | Low risk | Placebo used |
Incomplete outcome data (attrition bias) All outcomes | High risk | Loss to follow‐up: 16% in trial 1 and 36.6% in trial 2 |
Selective reporting (reporting bias) | Low risk | Not evident |
Other bias | Low risk | Not evident |