Hasan 2017.

Methods	Design: protocol for a 3‐arm, parallel, double‐blind, double‐dummy, placebo‐controlled superiority trial comparing 3 months of iron drops or iron‐containing micronutrient powders used for anaemia control in young children aged 8 months ± 14 days against placebo. Additional follow‐up 9 months post intervention. Researcher, caregiver, data collector, analysts, and participant‐blinded study design Unit of randomisation: individual. Participants randomly assigned to 1 of 3 arms with 1:1:1 allocation using computer‐generated schedule of randomly permuted blocks of fixed size stratification by sex and geographic union (each covered by different field team) to achieve balance between arms within each stratum. Randomisation list will be prepared by an independent statistician who will not reveal the block size. Allocation will occur by the field team according to the list, within the assigned union, once eligibility criteria are confirmed
Participants	Setting: Rupganj, a rural subdistrict/Upazilla of Narayanganj district, Bangladesh (50 km from Dhaka, Bangaldesh). This setting is non‐malaria endemic and has a low groundwater iron level Sample size: 3300 total Age range: 8 months ± 14 days Inclusion criteria Aged 8 months (± 14 days) at the time of randomisation Not expected to leave study location for > 1 week over the next 3 months or for > 1 month over the next 12 months Has legal guardian capable of providing informed consent Exclusion criteria Capillary Hb < 8.0 g/dL at the time of screening Drinking water iron concentration > 1 mg/L Diagnosed case of any clinical haemoglobinopathy (e.g. beta‐thalassaemia major, HbE‐beta thalassaemia) Current infective illness (i.e. respiratory infection, diarrhoea) with fever; however, children may be re‐screened after recovery if otherwise eligible Received iron supplements or iron‐containing MNPs in the previous month Known congenital anomaly, developmental disorder, or severe developmental delay Child of multiple birth, for example, twins, triplets
Interventions	Participants will be randomised in a 1:1:1 ratio to 3 arms: Arm 1 (1100 participants): iron syrup and placebo sachet. 12.5 mg daily of oral iron in syrup and a placebo sachet containing powders in identical packaging as the micronutrient powder but containing no micronutrients Arm 2 (1100 participants): micronutrient powder and placebo syrup. 12.5 mg daily of oral iron in micronutrient powder (including 0.3 mg of vitamin A, 30 mg of vitamin C, 0.16 mg of folic acid, and 5 mg of zinc) and placebo syrup containing no iron but with identical colour and flavour Arm 3 (1100 participants): placebo syrup and placebo sachet. Each participant will receive a pouch each week with a placebo bottle of syrup and 7 placebo sachets Administration: each participant will be asked to consume a syrup and sachet with powder every day for 3 months. After enrolment, assigned trained village health workers (VHWs) will visit child every week during 3 months of intervention and every month for the 9‐month post‐intervention period. VHWs will document and notify of any unscheduled hospital or clinic admissions by participants. VHSs will also record number of doses missed, collect empty bottles and sachets, and distribute new doses for the following week
Outcomes	Primary Cognitive development Secondary Cognitive indices Motor, language, behaviour, and temperament Prevalence of anaemia and iron deficiency Infection risks, especially diarrhoea and respiratory infection Timing of outcome assessment: the primary outcome, cognitive development, will be assessed after 3 months of intervention. It will also be assessed as a secondary outcome at 9 months post intervention. Secondary outcomes 2 and 3 will be assessed at 3 and 9 months post intervention. Morbidity data will be collected weekly and monthly during the intervention and post intervention, respectively
Notes	Comments: no mention of additional behaviour change strategies to support intake of syrups or powders, whether infant and young child feeding programmes are in place, or whether micronutrient powder content is mentioned or included in such programmes, as recommended by WHO Funding source: National Health and Medical Research Council (NHMRC) Principal investigator: Sant‐Rayn Pasricha Conflicts of interests: none declared Trial register ID:ACTRN12617000660381 Study start date: 1 June 2017 Study end date: 31March 2020 (anticipated) Current status: data collection