Sazawal 2014 (C).
| Methods |
Study design: cluster‐randomised trial Unit and method of allocation: cluster (n = 12) Method of sequence generation: unclear Masking of participants, personnel, and outcome assessors: no blinding of field staff or participants; analysts blinded to group assignments |
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| Participants |
Location of the study: Sangam Vihar, a low‐income, resettlement community in North Delhi, India Sample size: 292 Age: 6 to 24 months Sex: 58.8% boys in MNP group, 50.5% in fortified complementary food group, and 53.2% in control group Socioeconomic status: similar socioeconomic score between 3 groups Baseline prevalence of anaemia: not reported Baseline prevalence of soil helminths: not reported Baseline malaria prevalence: not reported Inclusion and exclusion criteria: eligible children selected from pre‐existing surveillance database were between 6 and 24 months old, consuming complementary food in addition to breastfeeding, not severely ill or with severe acute malnutrition requiring treatment, and willing to stay in study area for the next 6 months |
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| Interventions | Participants were randomly allocated to the following groups Interventions
19 MNP formulation = 978.26 μg of vitamin A (IU), 0.98 mg of thiamin, 1.11 mg of riboflavin, 13.04 mg of niacin, 1.3 mg of pyridoxine, 3.91 μg of cyanocobalamin, 19.57 μg of biotin, 260.87 μg of folic acid, 39.13 mg of vitamin C, 6.52 μg of vitamin D, 9.78 μg of vitamin E, 494.02 mg of calcium, 69.13 mg of magnesium, 81.52 mg of phosphorus, 12.5 mg of iron, 10.0 mg of zinc, 1.3 mg of copper, 2.58 mg of manganese, 6.52 mg of pantothenic acid Intervention delivered to mother monthly for 6 months. Children assigned to MNP were to be fed 1 sachet daily. Children "less than 12 months of age were provided half the quantity of the sprinkle" ‐ it is unclear what half the quantity refers to Comparison Group 2* (n = 94): nutrition education alone as control. Education sessions occurred once a month *For the purposes of this review, only groups 1 and 2 were compared Duration of intervention: 6 months |
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| Outcomes |
Primary: weight, height, length‐for‐age, weight‐for‐length, weight‐for‐age, haemoglobin, hematocrit, mean corpuscular volume, red cell distribution width, iron deficiency anaemia; anaemia defined as haemoglobin < 10 g/dL Secondary: intake compliance Timing of outcome assessment: weight and length measured at baseline and at end of study; complete haemogram estimation conducted at baseline and at end of study; information on compliance and anthropometry collected biweekly |
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| Notes |
Study start date: not reported Study end date: not reported Conflict(s) of interest: not reported Funding source(s): Trasher Foundation, World Health Organization Malaria‐endemic area: yes Comment Does not state if results are adjusted for clustering. Used a lower haemoglobin cutoff than recommended by World Health Organization |
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| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Unclear risk | Comment: clusters were matched but randomisation methods were not described |
| Allocation concealment (selection bias) | Unclear risk | Comment: states cluster sampling was carried out to identify 12 clusters but no methods were described. Eligible children selected within clusters were randomly assigned to arms but methods were not described. Child characteristics were used to match clusters but unclear where matching was relevant |
| Blinding of participants and personnel (performance bias) All outcomes | Unclear risk | Comment: not possible to blind field staff or mothers |
| Blinding of outcome assessment (detection bias) All outcomes | Low risk | Comment: those responsible for laboratory and data analysis blinded to group allocation |
| Incomplete outcome data (attrition bias) All outcomes | High risk | Comment: 5 lost to out‐migration in the MNP arm, and in control group, 2 lost to out‐migration and 1 died. Large proportion of refusals (those refusing to continue participating in the study because children did not like MNP or fortified complementary food) in the MNP arm (n = 30) |
| Selective reporting (reporting bias) | Unclear risk | Comment: in the MNP arm, 132 initially enrolled in the study, 30 (23%) withdrawn (children did not like the food with MNP), and 5 out‐migrated. In the control arm, 102 initially enrolled, 5 withdrew, 2 out‐migrated, and 1 died |
| Other bias | Unclear risk | Comment: results state that "usually, the sprinkle was added to milk, although it was acceptable with all other commonly‐consumed complementary foods" (quote). As a liquid drink, milk is not an appropriate vehicle to mix MNP. It is unclear if the milk was thick enough to stay on a spoon facing downward and thus had sufficient thickness for appropriate use. If mixed into liquids and the powder does not mix well, it is likely to be rejected by the child |