Taylor 2001.
Methods | Double‐blind randomised controlled trial. Factorial design (6 arms) with individual randomisation. | |
Participants | 425 children, both sexes (50% females), aged 6 ‐15 years (mean age 11.2 years), attending three rural primary schools in Kwa‐Zulu Natal, South Africa.The sample was stratified by school, age and sex. Four children with anaemia were included in the study (Hb < 80 g/L) ‐ all of these children were allocated to receive iron. Females over 12 years of age were excluded as the safety of albendazole in pregnancy has not been established. Socioeconomic status not reported although it was stated that the study was carried out in the third poorest province in South Africa. Anaemia at baseline was 35%. | |
Interventions | Children were allocated to 1 of the following groups: Group 1 (n = 56): children received 400 mg of albendazole weekly, 40 mg/kg of praziquantel weekly, and 65 mg of elemental iron (as 200 mg ferrous fumarate) plus 100 μg (0.1 mg) of folic acid weekly; Group 2 (n = 60): children received 400 mg of albendazole weekly, 40 mg/kg of praziquantel weekly, and placebo for iron and folic acid weekly; Group 3 (n = 60): children received 400 mg of albendazole for three days, 40 mg/kg of praziquantel weekly, and 65 mg of elemental iron (as 200 mg ferrous fumarate) plus 100 μg (0.1 mg) of folic acid weekly; Group 4 (n = 57): children received 400 mg of albendazole for three days, 40 mg/kg of praziquantel weekly, and placebo for iron and folic acid weekly; Group 5 (n = 101): children received placebo for albendazole, placebo for praziquantel and 65 mg of elemental iron (as 200 mg ferrous fumarate) plus 100 μg (0.1 mg) of folic acid weekly; Group 6 (n = 91): children received only placebos. For the purposes of this review only groups 5 and 6 were analysed. Length of the intervention: 10 weeks, children were followed up for a year with measures at baseline, 6 months and 12 months. |
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Outcomes | Height, weight, full blood count, anaemia (could not be extracted), presence of malarial parasites, presence of hookworm infection, urine infection or presence of blood in urine. | |
Notes | All groups received interventions under supervision by teachers It was reported that the area is endemic for malaria, schistosomiasis and hookworm. |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | Randomised controlled trial, with individual randomisation. 6‐arm trial (factorial design). Sample stratified by school, age and sex. Method of sequence generation not described. |
Allocation concealment (selection bias) | Low risk | Each pupil’s treatment was individually packaged at each phase of the study. Both the field team and pupils were blinded as to the type of drugs used. |
Blinding (performance bias and detection bias) All outcomes | Low risk | Participants: all pupils were blinded to the type of supplement used. Personnel: field team were blinded to the type of supplement used. Outcome assessors: not reported. |
Incomplete outcome data (attrition bias) All outcomes | High risk | 428 children entered the study. 4 children who were anaemic at baseline were all allocated to receive iron treatment. It was stated that intention to treat analysis was not carried out as data was missing for children who were absent from school on the day specimens were collected. It was stated that the sample sizes varied at each phase of the study. There was considerable variation in the size of treatment groups ‐ it was not clear why. The numbers available at each assessment point and missing data were not stated. The number with data on Hb at both 6 and 12 months follow up was 275 (64% of the original sample). |
Selective reporting (reporting bias) | Unclear risk | There is insufficient information to permit judgement. |
Other bias | High risk | It was stated that groups were similar at baseline for prevalence of anaemia and other variables. Although the figure suggests there was considerable variation in mean Hb levels at baseline ‐ although the differences between groups were not significant. Children with anaemia all received iron. The lack on information on attrition and missing data mean that results are difficult to interpret. |