| 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 |