Random sequence generation (selection bias) |
Low risk |
Quote: “A study statistician not involved in data collection generated 4 randomisation code lists in blocks of 9 (one list for each of the 4 enrolment sites)” |
Comment: Adequately done |
Allocation concealment (selection bias) |
Low risk |
Quote: “The researcher sealed the slips into individual opaque randomisation envelopes, marked each envelope with the trial name and an individual participant number” |
Comment: Adequately done |
Blinding of participants and personnel (performance bias) |
Low risk |
Quote: “IFA and MMN interventions were provided by using double‐masked procedures—that is, the capsules looked identical, and neither the participants nor the research team members were aware of the nutrient contents of the supplement capsules. For the LNS group, we used single‐masked procedures” |
Comment: Adquately done |
Blinding of outcome assessment (detection bias) |
Low risk |
Quote: “Researchers responsible for the data cleaning remained blind to the trial code until the database was fully cleaned” |
Comment: Adequately done |
Incomplete outcome data (attrition bias) |
Low risk |
Comment: IFA: 26/463 × 100 = 5.1% lost to follow‐up |
LNS: 26/462 × 100 = 5.6% lost to follow‐up |
Selective reporting (reporting bias) |
High risk |
Comment: Outcomes mentioned in the protocol are not completely reported in the study (NCT01239693) |
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 |
|