Bojang 2010 GMB.

Methods	Trial design: Individually randomized, controlled double‐blind trial Multicentre trial: Yes Trial duration: 2 years
Participants	Recruitment: Children presenting to the out‐patient clinic or ward at the Royal Teaching Hospital, Banjul; Medical Research Council Hospital, Fajara; and major health centres at Birkama, Essau and Faji Kunda during 2003 and 2004 transmission period (July to December), Sibanor was added during the 2004 period. Inclusion criteria: Age: 3 months to 9 years Anaemia: Hb < 7 g/dL Sickle‐cell anaemia: not reported Other: signed consent from guardian Other co‐morbidities: Not reported Sample size: 1200 enrolled
Interventions	Total number of intervention groups: 2 Presumptive treatment for all participants: Malaria was treated with intramuscular quinine followed by SP (majority) or CQ plus SP Children stayed in hospital until all signs of respiratory distress had subsided and Hb concentration had increased over that found on admission Children with Hb < 5 g/dL received blood transfusion All children received iron (ferrous fumerate syrup: 2 mg/kg) for 28 days, starting at time of discharge 1st follow‐up 7 days after discharge: Hb measurement and blood films for malaria, and treatment of any medical condition Interventions: IPT with SP Placebo (lactose and maize starch) Dose and timing of intervention: SP dose: 1.25 mg pyrimethamine/25 mg sulphadoxine per kg 1st dose (SP or placebo): at 7 day follow‐up Monthly doses until end of transmission season Duration of intervention period: until the end of the transmission season (July to December) Place and person delivering intervention: 1st dose administered by project staff at the hospital or health centre where the child had been admitted Monthly doses were given at health centre closest to where the child was living by trained field workers under supervision of clinic staff Co‐interventions: ITN use: was assessed at the end of the transmission period (20.7% in IPT group; 15.3% in placebo group) Other: none Additional treatments: Children with fever ≥ 37.5°C or a history of recent fever and malaria parasitaemia were treated with SP and CQ Children with severe malaria were treated with IM quinine Children that presented with uncomplicated malaria within one week of receiving SP chemoprevention received oral quinine Children with Hb < 9 g/dL were treated with iron for a further 28 days if they had completed their initial iron treatment Children with severe anaemia were referred for admission Co‐interventions equal in each arm? (if not, describe): Yes
Outcomes	Primary outcome: Proportion of children with moderate or severe anaemia at the end of the transmission period Secondary outcomes: Mean Hb level at end of transmission period Clinical episodes of malaria during the surveillance period Outpatient attendance Prevalence of parasitaemia and splenomegaly Nutritional status at the end oft he transmission period Compliance with treatment regimen Measurement time points: Day 7: Hb, blood film Passive surveillance during intervention period End of malaria season End of dry season How were outcomes assessed? Hb and blood film at day 7 and end of malaria transmission season Passive morbidity surveillance during intervention period Interviews with mothers at end of dry season
Notes	Country: The Gambia Setting: Urban and peri‐urban Transmission area: Seasonal transmission Source of funding: Gates Malaria partnership Conflict of interest stated: Authors state that they have no competing interests
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	"children were individually randomised into either the SP or the placebo group in a 1:1 ratio at the time of admission, using permuted blocks of 12 generated by computer using the STATA program. Blockswere not split across centres".
Allocation concealment (selection bias)	Low risk	"Tablets (enough for 6 doses) were packed into envelopes bearing the randomisation number by MRC staff not involved in the trial in any other way. The next envelope in sequence was assigned to the child at the time of their admission to hospital".
Blinding of participants and personnel (performance bias) All outcomes	Low risk	"None of the investigators, health care centre staff or laboratory staff participating in the trial had access to the code during the trial". Placebo and active tablet were identical in shape and colour.
Blinding of outcome assessment (detection bias) All outcomes	Low risk	"None of the investigators, health care centre staff or laboratory staff participating in the trial had access to the code during the trial".
Incomplete outcome data (attrition bias) All outcomes	High risk	Loss to follow‐up was similar in both groups (SP: 23%; placebo: 21.5%), but was over 20% in each group.
Selective reporting (reporting bias)	Low risk	All pre‐specified outcomes reported and checked with protocol.
Other bias	Low risk	Discrepancy between text and flow‐chart regarding number of children seen at follow‐up.