Gilgen 2001.
Study characteristics | ||
Methods |
Design: 4‐arm, randomised, double‐blind trial Unit of randomisation: individual level |
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Participants |
Setting/location: North‐East Bangladesh Sample size: 553 non‐pregnant and non‐breastfeeding tea pluckers Age range: 14‐66 years of age (mean age = 39.6 years) Baseline prevalence of anaemia: 85.7% Inclusion criteria: female tea pluckers, non‐pregnant and non‐breastfeeding Exclusion criteria: pregnant and breastfeeding women |
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Interventions | Participants were allocated to 1 of 4 groups.
Length of the intervention: 24 weeks For the purposes of this review, we only compared groups 1 and 4. |
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Outcomes |
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Notes |
Comments:
Study start date: November 1995 Study end date: March 1997 Funding source: UNICEF and The Nestle Foundation. D Gilgen received bursaries from Lucy Cavendish College, Cambridge, the Cambridge Philosophical Society and the University of Cambridge Conflicts of interest: not available |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Comment: participants were randomly assigned to 1 of the study groups. The random number generator in SPSS (Version 7.5) was used to create 4 groups of equal size and the process was repeated until there was no statistically significant difference between the randomised groups in mean age, years of plucking experience, productivity of the previous plucking season, haemoglobin and ferritin values, and prevalence and egg counts of Ascaris, Trichuris and hookworms. |
Allocation concealment (selection bias) | Unclear risk | Comment: not mentioned |
Blinding (performance bias and detection bias) All outcomes | Low risk | Comment: study described as double‐blind. Participants and personnel were not aware of the treatments; not described for outcome assessors |
Incomplete outcome data (attrition bias) All outcomes | Unclear risk | Comment: not mentioned |
Selective reporting (reporting bias) | Unclear risk | Comment: insufficient information to permit judgement |
Other bias | Low risk | Comment: no evidence of other bias |