Massaga 2003 TZA.

Study characteristics
Methods	Trial design: RCT Trial dates: June 1999 to May 2000 Length of follow‐up: 9 to 10 months of age
Participants	Number of participants: 291 infants Inclusion criteria: infants aged 12 to 16 weeks attending Maternal and Child Health (MCH) clinics for growth monitoring or to receive their third diphtheria‐pertussis‐tetanus (DPT) and oral poliovirus vaccine Exclusion criteria: congenital malformation; severe conditions that needed treatment in hospital; fever within past 2 days; packed‐cell volume < 24%; taking chemoprophylaxis
Interventions	Interventions Amodiaquine every 2 months and daily iron for 6 months 25 mg/kg over 3 days, with 10 mg/kg on first 2 days and 5 mg/kg on third day; 72 children Amodiaquine and placebo; 74 children Iron and placebo: 7.5 mg elemental iron; 73 children Placebo and placebo; 72 children Infants received 2.5 mL daily supplementation of iron (3 mg of ferric ammonium citrate mixture/mL) or placebo for 6 months. The first dose was given by the team and mothers were instructed how to administer the drug at home.
Outcomes	Outcomes included in the review Clinical malaria All‐cause mortality Hospital admissions Anaemia Adverse events Outcomes not included in the review: none
Notes	Location: Muheza district, north‐eastern Tanzania Malaria transmission: perennial/Holoendemic Funding: Danish International Development Agency
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	The trial used computer‐generated random numbers
Allocation concealment (selection bias)	Low risk	The trial used identical and centrally coded drugs and placebo
Blinding of participants and personnel (performance bias) All outcomes	Low risk	"To ensure that treatment allocation was concealed from parents and the research team, and to ensure that infants received the right dose of medication, the trial drugs were coded and pre‐packed."
Blinding of outcome assessment (detection bias) All outcomes	Low risk	"To ensure that treatment allocation was concealed from parents and the research team, and to ensure that infants received the right dose of medication, the trial drugs were coded and pre‐packed."
Incomplete outcome data (attrition bias) All outcomes	High risk	The percentage loss was 21%
Selective reporting (reporting bias)	Low risk	The trial authors reported most expected outcomes
Other bias	Low risk	The trial appeared to be free of other sources of bias