Agarwal 2003 (C).
Study characteristics | ||
Methods |
Design: 3‐arm, cluster‐randomised trial Unit of randomisation: class; "As school teachers did not agree to randomization at the individual girl level, the randomization was done at the class section level for the 60 class sections (all class sections taken)" (quote) |
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Participants |
Setting/location: 4 government senior secondary schools (all of these schools cater to the middle socioeconomic group population) in North‐East Delhi, India Sample size: 2088 girls Age range: 10‐17 years Baseline prevalence of anaemia: ~ 48% Inclusion criteria: secondary school girls aged 10‐17 years old Exclusion criteria: girls with haemoglobin < 7.0 g/dL |
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Interventions |
Intervention: 60 class sections were allocated to 1 of 3 groups.
Length of the intervention: 100 days (we did not consider the second period in which group 1 and 3 received supplementation) |
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Outcomes |
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Notes |
Comments:
Study start date: August 1996 Study end date: February 1999 Funding source: UNICEF, Delhi Conflicts of interest: Not available |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | Comment: randomisation was done at the class section level for 60 class sections. Method of sequence generation not described |
Allocation concealment (selection bias) | Low risk | Comment: not mentioned; however, since randomisation was performed at class section level, selection bias at individual level was unlikely |
Blinding (performance bias and detection bias) All outcomes | Unclear risk | Comment: not described for participants, personnel nor outcome assessors; however, seems unlikely to have been blinded, and no placebo was used |
Incomplete outcome data (attrition bias) All outcomes | Low risk | Comment: 7 girls in the daily administered group during the second week of intervention complained of gastric side effects and requested not to continue in the study and were excluded |
Selective reporting (reporting bias) | High risk | Comment: girls with haemoglobin < 70 g/L (0.3%) were eliminated from the analysis. Plasma ferritin and C‐reactive proteins (CRP) were estimated in every tenth girl of the study groups; it is unclear how each girl was selected for these analyses. Data not available for the second measurement |
Other bias | Low risk | Comment: appears to be free of other bias |