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. 2016 Apr 18;2016(4):CD009747. doi: 10.1002/14651858.CD009747.pub2

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:
  1. Study A: Non‐pregnant women and men; data for women presented separately. Participants with haemoglobin E or B thalassaemia trait were excluded. Study performed between March 1977 and March 1979

  2. Study C: Study performed between September 1978 and August 1980

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
Interventions Intervention:
  1. Trial 1: 5 groups: placebo, daily iron 120 mg supervised, daily iron 240 mg supervised, daily iron 240 mg + 5 mg folic acid supervised, daily iron 120 mg unsupervised

  2. Trial 2: 4 groups: placebo, daily iron 120 mg, daily iron 240 mg, daily iron 240 mg plus 5 mg of folic acid


Control: placebo
Duration: 3 months
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
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