Tomashek 2001 TNZ.

Methods	Trial design: Randomized double‐blind trial Multicentre trial: No Trial duration: March 1998 to May 1998
Participants	Recruitment: Children living in refugee camp diagnosed with clinical anaemia Inclusion criteria: Age: 6 to 59 months Anaemia: Hb 5.0 to 8.0 g/dL Malaria: severe malarial infection excluded Informed consent Exclusion criteria Sickle‐cell anaemia Signs or symptoms of heart failure splenomegaly Other co‐morbidities: Hookworm Sample size: 238 randomized, 215 analysed
Interventions	Presumptive treatment for all participants: Treatment for malaria with SP (> 48 months: one SP tablet (500 mg sulphadoxine and 25 mg pyrimethamine); 12 to 47 months: half a tablet; 6 to 12 months: quarter of a tablet) Mebendazole (24 to 59 months one tablet (500 mg mebendazole); 12 to 23 months half a tablet; 6 to 12 months did not receive) Total number of intervention groups: 3 Vitamin placebo 3X per week Vitamin placebo + SP VAC + SP Dose, and timing of intervention: Vitamin (or placebo) given 3 times a week (> 18 months: chewable tablet of 400 µg vitamin A and 75 mg vitamin C; < 18 months: chewable tablet: 400 µg vitamin A and 30 mg vitamin C) SP week 4, 8, and 12 (> 48 months: one SP tablet (500 mg sulphadoxine and 25 mg pyrimethamine); 12 to 47 months: half a tablet; 6 to 12 months: quarter of a tablet) Duration of intervention period: 3 months Place and person delivering intervention: Home health visitor administrated one dose of iron and placebo or iron and VAC at weekly home visits At visits parents were given 2 additional doses oft he appropriate treatment to be given on every second day for that week In addition, each participant visited the clinic monthly (at week 4, 8, 12) for physical examination, weight and height measurement, Hb measurement, malaria blood smear Participants in group 2 and 3 were given monthly doses of SP at this visit Co‐interventions: ITN use: not reported Other: Iron and folic acid supplement for all children (> 18 months: one tablet containing 250 µg ferrous fumerate (= 60mg of elemental iron) and 250 µg folic acid three times a week; < 18 months received half a tablet 3 times a week) Additional treatments: Participants in group 1 were given CQ if they presented to the clinic with symptomatic malaria Co‐interventions equal in each arm? (if not, describe): No
Outcomes	Outcomes not specified as primary or secondary outcomes Mean Hb Prevalence of anaemia (Hb < 11.0 g/dL) Mean TfR level Prevalence of iron deficiency (TfR < 8.5 µg/mL) Proportion of positive high density parasitaemia Measurement time points: Hb: enrolment, week 4, 8 and 12 TfR: enrolment, week 12 How were outcomes assessed? At each monthly visit: physical examination, height and weight measurement, Hb and malaria smear Laboratory measurements
Notes	Country: Tanzania Setting: Rural Transmission area: Not reported Source of funding: Woodruff Foundation, Atlanta, Georgia. Conflict of interest stated: Not reported
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	Computer‐generated randomization list.
Allocation concealment (selection bias)	Unclear risk	Not described.
Blinding of participants and personnel (performance bias) All outcomes	High risk	Personnel distributing medications had access to the list of group assignment; group 1 did not receive SP placebo.
Blinding of outcome assessment (detection bias) All outcomes	Low risk	"The study coordinator and the study nurse, who were responsible for distributing medications, were the only team members with access to the register containing participants' names and group assignment. All other research team members were blinded to participants’ treatment group assignment". Laboratory workers were not aware of group assignment.
Incomplete outcome data (attrition bias) All outcomes	Unclear risk	All participants accounted for. Loss to follow‐up rates: Group 1: 6%, Group 2: 10%; Group 3: 13% reasons for loss to follow‐up not stratified according to groups.
Selective reporting (reporting bias)	Low risk	All pre‐specified outcomes reported on.
Other bias	Low risk	No.