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. 2019 Jun 17;2019(6):CD011695. doi: 10.1002/14651858.CD011695.pub2

Oelofse 2003.

Methods RCT
Sample size: 60
Inclusion criteria: infants aged 6 months enrolled at the clinic with birth weight > 2.5 kg and no congenital abnormalities
Exclusion criteria: birth weight < 2.5 kg or born with congenital abnormalities
Participants Children
Age: 6–12 months
Country: South Africa
Setting: urban disadvantaged black community, Kayamandi, in the Western Cape, South Africa (12,000 inhabitants). Community has low SES indicated by type of housing, possession of household appliances, and access to basic amenities; low education or no formal education and most of the inhabitants worked in the industries in the city or as domestic workers in private homes. Infants were in the care of grandparents or other family members.
Interventions Type: supplementation micronutrient and fortified complementary food. Demonstrations were provided on how to prepare the porridge. A measuring spoon was provided to ensure the correct amount of porridge to be consumed. During home visits, the research assistants deliver batches of cereals and checked the consumption by the infant.
Urban specificity: none
Level of factors tackled: individual
Delivery: community based (delivered in the home). At intervals of 1 week the research assistants paid home visits to deliver the next batch of infant cereal to the IG. These visits were also used to check cereal consumption by the infant.
Duration (years): 1.3
Comparison:
IG: micronutrient‐fortified complementary food throughout the 6‐month period. the quantity prescribed for use was 60 g/day of dry cereal and would ensure consumption of 100% of RDA for vitamin A, 80% for iron, and > 100% for zinc.
CG: no complementary food, but continued with normal diet
Measurement: time points results reported for in the paper were 6 months (x3) and 12 months (x3).
PROGRESS at baseline: none
Outcomes WFA, HFA, WFH
Notes No funding information
Impact of the intervention:
IG: baseline serum retinol experimental (mean 30.5, SD 7.4) and 12 months (mean 26.8, SD 5.8), total iron experimental baseline (mean 10.6, SD 4.4) and 12 months (mean 8.0, SD 3.2), haemoglobin experimental baseline (mean 10.8, SD 1.0) and 12 months (mean 10.8, SD 0.9), zinc experimental baseline (mean 79.3, SD 12.1) and 12 months (mean 85.0, SD 9.1), HAZ experimental baseline (mean –0.68, SD 1.35) and 12 months (mean –0.94, SD 0.70), WFA z‐score experimental baseline (mean 0.71, SD 1.10) and 12 months (mean –0.55, SD 0.99), WFH z‐score experimental baseline (mean 1.58, SD 1.10) and 12 months (mean 0.11 SD 1.10)
CG: baseline serum retinol control baseline (mean 28.8, SD 6.6) and 12 months (mean 21.4, SD 5.7), total iron control (mean 9.6, SD 4.0) and 12 months (mean 6.5, SD 3.9), haemoglobin control (mean 10.3, SD 1.0) and 12 months (mean 21.4, SD 5.7), zinc control (mean 69.1, SD 15.8) and 12 months (mean 73.6, SD 12.1), HAZ control (mean –0.57, SD 0.87) and 12 months (mean ‐0.72, SD 1.1), and WFA z‐score control (mean 0.46, SD 1.21) and 12 months (mean ‐0.52, SD 1.6), HAZ control (mean –0.57, SD 0.87) and 12 months (mean –0.72, SD 1.10), WFH z‐score control (mean 1.11, SD 1.10) and 12 months (mean 0.42, SD 1.60)
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Unclear risk Each infant randomly allocated to either IG or CG. The paper did not explain how the randomisation process worked.
Allocation concealment (selection bias) High risk No mention of concealing to participants the group they were allocated to.
Blinding of participants and personnel (performance bias) 
 All outcomes High risk No mention of blinding in the paper.
Blinding of outcome assessment (detection bias) 
 All outcomes High risk No mention in the paper of blinding the outcome assessment.
Incomplete outcome data (attrition bias) 
 All outcomes High risk 50% of participants did not complete the trial and there was no analysis of characteristics of those who remained and those who dropped out between the CG and IG. Attrition was slightly higher in the IG.
Selective reporting (reporting bias) High risk No published protocol to establish this risk.
Other bias High risk Serum zinc levels differed significantly at baseline between the CG and IG. Unclear if participants benefited from other ongoing interventions during the study period.
Similarity of outcome measures at baseline Unclear risk Children outcomes were not measured prior to the intervention.
Similarity of baseline characteristics Unclear risk Baseline characteristics of the study and control providers not reported.
Protection against contamination Low risk Unlikely that the CG received the intervention as it was a supplementation intervention.