Desai 2003 KEN.

Methods	Trial design: RCT with 2 X 2 factorial design Multicentre trial: no Trial duration: Children were screened between April to November 1999
Participants	Recruitment: All resident children in 15 villages in Asembo, Bondo district, Kenya were screened Inclusion criteria: Age: 2 to 36 months Anaemia: mild anaemia (Hb 7.0 to 10.9 g/dL) Malaria: aparasitaemic or parasite counts < 20,000 parasites/mm3 Sickle‐cell anaemia: children with HbSS phenotype excluded Other: no reported iron supplementation, SP treatment or blood transfusions within the last 2 weeks Other co‐morbidities: Not reported Sample size: 554 participants randomized; 546 enrolled; 491 followed up at 12 weeks; 468 followed up at 24 weeks.
Interventions	Total number of intervention groups: 4 Presumptive treatment for all participants: single dose of SP (500 mg sulphadoxine and 25 mg pyrimethamine per tablet). Children ≤ 10kg received half a tablet, children > 10kg received one tablet IPT (SP) + iron IPT (SP) + iron placebo IPT placebo + daily iron IPT placebo + iron placebo (double placebo) Dose, and timing of intervention: IPT with SP (or placebo) at 4 and 8 weeks; iron (or placebo) given daily for 12 weeks (3 to 6 mg/kg/day, orally). IPT given as crushed tablets mixed with water. Duration of intervention period: 12 weeks Place and person delivering intervention: Iron delivered through daily home visits by staff Unclear where SP presumptive dose was administered Unclear where and by whom other doses of SP were given – not reported Co‐interventions: ITN use: All households were issued with ITNs but the use thereof was not further assessed Other: none Additional treatments: Children with symptomatic malaria (temp ≥ 37.5°C with any malaria parasitaemia or parasitaemia > 5000 parasites/mm3) received oral quinine (10 mg/kg, 3 times/day for 7 days). Children who developed severe malaria, severe anaemia (Hb < 5.0g/dL) or other severe disease requiring hospitalization were referred for further treatment. Co‐interventions equal in each arm? (if not, describe): Yes
Outcomes	Outcomes not specified according to primary and secondary outcomes: Hb concentration ( measured in g/dL) Hematological recovery (Hb ≥11 g/dL before or at week 12) Severe anaemia (Hb < 7g/dL before or at week 12) MCV (measured in fL) sTfR concentration (measured in µg/mL) Parasite density (parasites/mm3) Malaria parasitaemia Clinical malaria (axillary temperature 37.5°C with co‐existing malaria parasitaemia) Clinic visits (Incidence, number of episodes) Measurement time points: Every 4 weeks How were outcomes assessed? Home visits every 2 weeks for completion of a morbidity questionnaire and assessment of cutaneous reactions and axillary temperature Fingerprick or heel‐prick blood samples were obtained every 4 weeks (just before the next dose of SP or SP placebo) for Hb levels and presence of malaria parasites The frequency of local clinic and hospital attendance was monitored using a passive surveillance system
Notes	Country: Western Kenya Setting: Rural Transmission area: Perennial transmission Source of funding: US agency for International Development, Netherlands Foundation for the advancement of Tropical research Conflict of interest stated: Not reported
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	"Balanced block randomisation (8 children/block) and a random number listing generated independently before the study".
Allocation concealment (selection bias)	Unclear risk	Children were assigned to 1 of the 4 groups sequentially according to the random number listing by one author. Drugs and placebos were identical. Code to true drug and placebo assignment was revealed only after completion of analysis. Still unclear whether allocation was concealed sufficiently – did they use numbered envelopes or bottles?
Blinding of participants and personnel (performance bias) All outcomes	Low risk	Placebo and trial drugs were identical; participants (or their mothers) and staff administering the drugs were thus not aware of the study group. The code was only broken after data analysis.
Blinding of outcome assessment (detection bias) All outcomes	Low risk	Placebo and trial drugs were identical; staff assessing outcomes were thus not aware of the trial group. The code was only broken after data analysis.
Incomplete outcome data (attrition bias) All outcomes	High risk	Loss to follow‐up at 12 weeks: 4% (IPT + iron), 8.6% (iron), 6.6% (IPT) and 20.5% (double placebo). Reported reason: mostly migration (23/28 for double placebo group), loss to follow‐up at 24 weeks – data missing.
Selective reporting (reporting bias)	Unclear risk	Outcomes not listed in Methods section (protocol?).
Other bias	Low risk	No.