Random sequence generation (selection bias) |
Low risk |
Quote: “For the randomisation, the study statistician at UC Davis first stratified the 64 clusters by sub district and union, and then assigned each cluster to 1 of 4 sets containing 16 clusters each” |
Comment: Adequately done |
Allocation concealment (selection bias) |
Unclear risk |
Comment: Insufficient information to permit judgement |
Blinding of participants and personnel (performance bias) |
High risk |
Quote: “It was not possible to blind the women to the type of supplement provided because the supplements were very different in appearance and taste” |
Comment: High risk of bias |
Blinding of outcome assessment (detection bias) |
Low risk |
Quote: “None of the evaluation staff members was involved in supplement delivery” |
“Nonetheless, researchers responsible for the collection of outcome data were kept blind to study assignment” |
Comment: Adequately done |
Incomplete outcome data (attrition bias) |
High risk |
Comment: IFA: 413/2964 × 100 = 13.9% lost to follow‐up |
LNS‐PL: 149/1047 × 100 = 14.2% lost to follow‐up |
Selective reporting (reporting bias) |
High risk |
Comment: Not all outcomes specified in protocol have been reported in the results section (NCT01715038) |
Other bias |
Low risk |
Comment: No other potential sources of bias reported |
Was the allocation sequence adequately generated? |
Unclear risk |
|
Was the allocation adequately concealed? |
Unclear risk |
|
Were baseline outcome measurements similar? |
Unclear risk |
|
Were baseline characteristics similar? |
Unclear risk |
|
Were incomplete outcome data adequately addressed? |
Unclear risk |
|
Was knowledge of the allocated intervention adequately prevented during the study? |
Unclear risk |
|
Was the study adequately protected against contamination? |
Unclear risk |
|
Was the study free from selective outcome reporting? |
Unclear risk |
|
Was the study free from other risk of bias? |
Unclear risk |
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