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. 2019 Jan 31;2019(1):CD009218. doi: 10.1002/14651858.CD009218.pub3

Muro 1999 (C).

Study characteristics
Methods Design: 3‐arm, cluster‐randomised, community‐based, controlled trial
Unit of randomisation: school level
Participants Setting/location: 5 schools in Dar‐es‐Salaam, Tanzania
Sample size: 237 adolescent girls
Age range: 14‐17 years
Baseline prevalence of anaemia: ~ 48%
Inclusion criteria:
  1. menarche

  2. written informed consent from the girls and their parents

  3. anaemic and non‐anaemic girls


Exclusion criterion: girls suffering from infection with fever at the time of the interview
Interventions Participants were allocated to 1 of 3 groups.
  1. Group 1 (n = 78): girls received 65 mg of elemental iron plus 250 μg (0.25 mg) of folic acid once a week, as well as communication sessions.

  2. Group 2 (n = 39): girls received 65 mg of elemental iron and 250 μg (0.25 mg) of folic acid once a week.

  3. Group 3 (n = 120): girls received no intervention.


Length of the intervention: 8 weeks
For the purposes of this review, we compared groups 2 and 3 only.
Outcomes
  1. Anaemia

  2. Side effects

  3. Compliance (only for those who took the supplements)

Notes Comments:
  1. Full compliance, measured during the third week by positive iron stool tests, was 60‐100% and declined to 40‐87% at the 5th week. Self‐reported compliance tended to be higher.

  2. Supplements were distributed by the school teacher and a supplementation record book was provided to each class leader for the weekly collection of information about ingestion of the tablet, eventual side effects, illness, and absenteeism throughout the whole supplementation period. The reported side effects were: increased appetite, stomach irritation, increase in activity, and less sleepiness.

  3. Malaria endemic area.

  4. We adjusted the results of this study to account for the effect of clustering in the data; the estimated effective sample size was used in the analyses. 


Study start date: August 1996
Study end date: November 1996
Funding source: not available
Conflicts of interest: not available
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Unclear risk Comment: method of sequence generation not described
Allocation concealment (selection bias) Unclear risk Comment: each group should have contained a similar number of girls. However, this goal was not reached, because after the schools had been randomly assigned to the 3 groups, the parents of the girls in school 4, who were assigned to receive iron supplementation without communication, did not approve of their daughters receiving iron tablets. The girls from this school were added to the non‐intervention group
Blinding (performance bias and detection bias)
All outcomes High risk Comment: participants and personnel were aware of the treatment; outcome assessors seemed to be aware of the treatment
Incomplete outcome data (attrition bias)
All outcomes Low risk Comment: 100% of participants finished the treatment
Selective reporting (reporting bias) Unclear risk Comment: insufficient information to permit judgement
Other bias Low risk Comment: study appeared to be free of other bias