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. 2019 Feb 19;2019(2):CD012818. doi: 10.1002/14651858.CD012818.pub2

Iannotti 2017.

Methods Study design: randomized controlled trial
 Study duration: 6 months
Start date: March 2015
End date: December 2015
Participants Country and setting: Ecuador (upper‐middle‐income country); Cotopaxi province
Population: Mestizo ethnic majority, 22% self identified as indigenous in 2010 census
Inclusion criteria:

  1. infant aged 6 to 9 months

  2. singleton birth

  3. infant in good health


Exclusion criteria:

  1. congenital heart condition

  2. SAM status

  3. known egg allergy


Nutritional status: baseline mean LAZ: −2.09 in intervention group, −1.71 in control group
Number: 160 (78 in intervention group, 82 in control group)
Age: mean age at enrollment: 7.4 months in intervention group, 7.7 months in control group
Sex: 30% female in intervention group, 43% female in control group
Typical diet: not described
Interventions Intervention: eggs; 1 medium‐sized egg (approximately 50 g) per day, provided on a weekly basis to children in the treatment group over a 6‐month period
Control: no intervention; controls were exposed to social marketing intervention to participate in trial
Outcomes Primary:

  1. linear growth

  2. morbidity symptoms


Secondary:

  1. plasma concentrations of biomarkers in choline pathways

  2. vitamin B12

  3. vitamin A

  4. essential fatty acids


Measurement:

  1. linear growth: 2 measures using a seca 417 portable infantometer to the nearest 1 mm (discrepancy of 5 mm or more resulted in third measurement, averaged with the closest measure)

  2. weight gain: 2 measures using the seca Model 874 Electronic Digital scale with mother‐child tare feature to nearest 0.01 kg (discrepancy of 0.05 kg or more resulted in third measurement, averaged with other 2)


Time points: baseline, 6 months
Notes Funding: Mathile Institute for the Advancement of Human Nutrition
Declared conflict of interest: "At the time of the study, Drs Reinhart and Palacios worked for The Mathile Institute, which funded the study. The Mathile Institute has no vested interest in the outcome(s) of the study."
Other notes: loss to follow‐up: 11, or 7% of total study population (3 in intervention group, 8 in control group).
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk Comment: block randomization
Allocation concealment (selection bias) Low risk Comment: use of alpha/beta sealed envelopes during allocation. Field study team blinded except for 1 individual responsible for enrolling and monitoring participants.
Blinding of participants and personnel (performance bias) 
 All outcomes High risk Comment: non‐blinding likely to have influenced care in the control group, who were exposed to social media messages around egg consumption; 24‐hour recall frequency of dietary intake showed an increase in egg consumption in both groups between baseline and endline
Blinding of outcome assessment (detection bias) 
 All outcomes Low risk Comment: objective outcome assessment unlikely to have introduced bias. Investigators masked to group assignment during analysis.
Incomplete outcome data (attrition bias) 
 All outcomes Low risk Comment: low losses to follow‐up (7%), balanced between intervention and control groups
Selective reporting (reporting bias) Low risk Comment: all prespecified outcomes and expected outcomes of interest to the review were reported
Other bias High risk Comment: significant baseline imbalances between intervention and control groups, respectively, for LAZ (−2.09 (± 1.08) vs −1.71 (± 0.92)) and WAZ (−0.91 (± 1.24) vs −0.40 (± 0.92))