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. 2023 Feb 15;2023(2):CD011507. doi: 10.1002/14651858.CD011507.pub3

Malvasi 2014.

Study characteristics
Methods Study type: parallel RCT
Participants 65 pregnant women from Italy
Inclusion criteria: healthy pregnant women, aged between 30 to 40, between 13 and 24 weeks' gestation, BMI between 25 to 30 kg/m2.
Exclusion criteria: diabetes mellitus, cardiovascular disease, chronic hypertension, autoimmune disease, dysthyroidism.
Location: Bari, Italy
Timeframe: January to December 2012
Interventions Intervention: a combination of 2000 mg myo‐inositol, 400 mg d‐chiro‐inositol, 400 mcg folic acid, 10 mg manganese
Duration of myo‐inositol supplementation: 60 days
Comparison: placebo (but not stated what placebo was)
Outcomes Maternal: total cholesterol, LDL, HDL, blood glucose
Criteria used to diagnose gestational diabetes: not stated
Infant: not stated
Notes Sample size calculation: not stated
Funding source: not stated
Conflicts of interest: none reported
Further information was received following email contact with the authors.
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk Randomisation sequence was generated by a random number table.
Allocation concealment (selection bias) Low risk Allocation was controlled by an independent statistician who assigned numbered patients to groups using sealed numbered containers.
Blinding of participants and personnel (performance bias)
All outcomes Unclear risk Participants were blinded. Clinicians were aware of treatment allocation.
Blinding of outcome assessment (detection bias)
All outcomes Low risk Outcome assessors were blinded. 
Incomplete outcome data (attrition bias)
All outcomes High risk 65 women were initially enrolled, 17 of which were excluded; 6 did not meet inclusion criteria, 4 refused to participate, 7 left the study spontaneously. Analysis was conducted on the remaining 48 women.
Selective reporting (reporting bias) Low risk All pre‐specified outcomes are reported on (total cholesterol, LDL, HDL, blood glucose). No other maternal, pregnancy or neonatal outcomes are specified or reported.
Other bias Low risk Appears free of other bias. The authors do not report any potential conflicts of interest.