Random sequence generation (selection bias) |
Unclear risk |
|
Allocation concealment (selection bias) |
Unclear risk |
|
Blinding of participants and personnel (performance bias) |
Unclear risk |
|
Blinding of outcome assessment (detection bias) |
Unclear risk |
|
Incomplete outcome data (attrition bias) |
Unclear risk |
|
Selective reporting (reporting bias) |
Unclear risk |
|
Other bias |
Unclear risk |
|
Was the allocation sequence adequately generated? |
High risk |
Quote: “It was not possible to use a randomised design of supplemented vs control subjects because of the relatively small number of births in Keneba” |
Comment: Study design did not permit randomisation to take place |
Was the allocation adequately concealed? |
Unclear risk |
Comment: Insufficient information to permit judgement |
Were baseline outcome measurements similar? |
Low risk |
Comment: Baseline outcomes were similar across groups |
Were baseline characteristics similar? |
Low risk |
Comment: Baseline characteristics were similar across groups |
Were incomplete outcome data adequately addressed? |
Low risk |
Quote: “Birthweights were unobtainable in three cases pre‐supplement and two cases post‐supplement because of referral for hospital deliveries” |
Was knowledge of the allocated intervention adequately prevented during the study? |
Unclear risk |
Comment: Insufficient information to permit judgement |
Was the study adequately protected against contamination? |
Low risk |
Comment: No blinding but the outcomes are not likely to be influenced by lack of blinding |
Was the study free from selective outcome reporting? |
Unclear risk |
Comment: Published protocol not found. The outcomes specified in the methodology section have been reported in the results section |
Was the study free from other risk of bias? |
Low risk |
Comment: No other potential sources of bias reported |