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. 2020 Feb 28;2020(2):CD008959. doi: 10.1002/14651858.CD008959.pub3

Matias 2018 (C).

Methods Study design: cluster‐randomised effectiveness trial with 4 arms in a ratio of 1:1:1:1
Unit and method of allocation: randomisation at union level
Method of sequence generation: randomly assigned 64 clusters to the 4 arms equally by sorting on a randomly generated, uniformly distributed number (with use of SAS for Windows, release 9.2; SAS Institute)
Masking of participants, personnel, and outcome assessors: personnel and outcome assessors were blinded to group assignment. However, participant blinding was not clear
Participants Location of the study: 11 rural unions of the Badarganj and Chirirbandar subdistricts of the northwest region of Bangladesh
Sample size: 4011 pregnant women and 1346 unborn children
Age: not reported
Sex: both sexes (mentioned children)
Socioeconomic status: not reported but study areas are among the poorest areas of Bangladesh
Baseline prevalence of anaemia: not reported
Baseline prevalence of soil helminths: not reported
Baseline malaria prevalence: not reported
Inclusion and exclusion criteria: all pregnant women residing in the area of work of any of the 64 community health workers were eligible if they met the following eligibility criteria at enrolment: (1) gestational age was ≤ 20 weeks and (2) had no plans to move out of study area for 3 years after enrolment
Interventions Participants (2964 pregnant women) were randomly assigned to 1 of 3 groups and were fed at feeding centres: LNS‐LNS arm (1047 women with 327 livebirths), IFA‐LNS arm (930 women with 277 livebirths), and IFA‐MNP arm (1052 women with 324 livebirths). For the purposes of this review, arms 1 and 2 were not included
Intervention (1052 women with 324 livebirths): IFA‐MNP arm; women received iron plus folic acid (IFA; 1 tablet containing 60 mg of Fe and 400 μg of folic acid) daily during pregnancy and every other day during the first 3 months postpartum, and their children received MNPs (1 sachet/d) containing 15 micronutrients (including 10 mg of iron, 400 μg of vitamin A, 4.1 mg of zinc, 0.5 mg of thiamin, 0.5 mg of riboflavin, 6 mg of niacin, 0.15 mg of folic acid, 0.5 mg of vitamin B6, 0.9 mg of vitamin B12, 30 mg of vitamin C, 5 mcg of vitamin D, 5 mg of vitamin E, 0.56 mg of copper, 90 mcg of iodine, 17 mcg of selenium) from 6 to 24 months of age
Comparison (982 pregnant women with 298 livebirths): IFA‐control arm; women received IFA daily during pregnancy and every other day during the first 3 months postpartum, and their children received no supplements
Duration of intervention: 18 months after postpartum
Outcomes Primary: anaemia (haemoglobin < 110 g/L), iron deficiency (ferritin < 12 µg/L or soluble transferrin receptor > 8.3 mg/L), iron deficiency anaemia (IDA)
Secondary: not reported
Timing of outcome assessment: 18 months postpartum
Notes Study start date: between 15 October 2011 and 31 August 2012 (pregnant women enrolment)
Study end date: not reported (April 2013 and February 2014 as 18 months postpartum follow‐up)
Conflict(s) of interest: none reported
Funding source(s): US Agency for International Development Food and Nutrition Technical Assistance III Project (FANTA), managed by Family Health International 360
Malaria‐endemic area: not reported
Comment: home fortification using lipid‐based nutrient supplements (LNS) or MNP reduced IDA in 18‐month‐old Bangladeshi children. Provision of LNS in both pregnancy and childhood also reduced child anaemia and iron deficiency. Ferritin concentrations were adjusted for inflammation using correction factors
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk Comment: randomly assigned 64 clusters to the 4 arms equally by sorting, using a randomly generated, uniformly distributed number (with use of SAS for Windows, release 9.2; SAS Institute)
Allocation concealment (selection bias) Low risk Comment: random assignment performed
Blinding of participants and personnel (performance bias) 
 All outcomes Low risk Comment: team members were blinded to group assignment
Blinding of outcome assessment (detection bias) 
 All outcomes Low risk Comment: study evaluation teams were kept blind to group assignment
Incomplete outcome data (attrition bias) 
 All outcomes Low risk Comment: attrition rate was 15% in treatment group and 17% in control group with no significant differences between arms
Selective reporting (reporting bias) Low risk Comment: appears to be no selective reporting, as outcomes were pre‐specified in the trial registration; protocol approved by institutional review board
Other bias Low risk Comment: intention‐to‐treat analysis performed