Luo 2017 (C).
| Methods |
Study design: cluster‐randomised controlled trial Unit and method of allocation: randomisation at village level Method of sequence generation: randomly assigned 117 villages to control group and 234 villages to micronutrient group using computer code (in Stata version 12) Masking of participants, personnel, and outcome assessors: caregivers were not aware that they were in an RCT. Outcome assessor blinding was not clear |
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| Participants |
Location of the study: Shaanxi Province, China Sample size: 1802 children Age: children aged 6 to 11 months Sex: 53.5% male in intervention group, 51.0% male in control group Socioeconomic status: relatively poor and rural Baseline prevalence of anaemia: 48% Baseline prevalence of soil helminths: not reported Baseline malaria prevalence: not reported Inclusion and exclusion criteria: all townships in each county were included except for 1 township per county that housed the county seat and townships that did not have any villages with at least 800 people |
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| Interventions | Participants were randomly assigned to 1 of 3 groups and were fed at feeding centres Intervention (1192 children, 629 in cohort 1 and 563 in cohort 2): caregivers in the MNP arm were given a 6‐month supply of sachets every 6 months (each sachet containing 6.0 mg of iron as ferrous lactate, 4.8 mg of zinc, 200 μg of vitamin A, 50 mg of vitamin C, 5 μg of vitamin D, 1.55 mg of vitamin E, 0.3 mg of vitamin B1, 0.5 mg of vitamin B2, 0.3 mg of vitamin B6, 0.5 μg of vitamin B12, 66 μg of folic acid, and 3.0 mg of niacin). They were also given information about causes and consequences of anaemia along with oral and written instructions on how to use the powder, specifically to give 1 packet per day mixed with the child’s food. 'NurtureMate' is a Heinz‐produced MNP Comparison (610 children, 313 in cohort 1 and 297 in cohort 2): no intervention Duration of intervention: 18 months for both cohorts |
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| Outcomes |
Primary: haemoglobin (measured in g/L), 2 sub‐indices of Bayley Scales of Infant Development Secondary: feeding behaviour Timing of outcome assessment: 6, 12, and 18 months after the start of the intervention |
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| Notes |
Study start date: April 2013 for cohort 1 and October 2013 for cohort 2 Study end date: October 2014 for cohort 1 and April 2015 for cohort 2 Conflict(s) of interest: funders of the study had no role in study design, data collection, data analysis, data interpretation, or writing of the report Funding source(s): International Initiative for Impact Evaluation (3ie), National Natural Science Foundation of China (71473239, 71703083), UBS Optimus Foundation, China Medical Board, Bank of East Asia, Huaqiao Foundation, Bill & Melinda Gates Foundation‐HBGDki Initiative, Noblesse, HJ Heinz Company Foundation Malaria‐endemic area: not reported Comments
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| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk | Comment: randomly assigned 117 villages to control group and 234 villages to micronutrient group using computer code (in Stata version 12) |
| Allocation concealment (selection bias) | Low risk | Comment: randomly assigned using computer code; concealment probably attempted |
| Blinding of participants and personnel (performance bias) All outcomes | Unclear risk | Comment: caregivers were not aware that they were in an RCT, but no placebo was used |
| Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | Comment: not described |
| Incomplete outcome data (attrition bias) All outcomes | High risk | Comment: attrition rate was high in both control and treatment groups (approximately 28%), but there was no difference between arms |
| Selective reporting (reporting bias) | Low risk | Comment: appears to be no selective reporting, as outcomes were pre‐specified in the trial registration |
| Other bias | Low risk | Comment: intention‐to‐treat analysis performed |