Malvasi 2017.

Study characteristics
Methods	Study type: prospective, double‐blinded, placebo‐controlled, single‐centre RCT
Participants	104 pregnant women from Italy Inclusion criteria: BMI between 25 to 30 kg/m2 in the first trimester, aged between 25 to 40 years, singleton pregnancy. Women were 10 to 16 weeks’ gestation at study entry. Exclusion criteria: diabetes mellitus, cardiovascular disease, chronic hypertension, autoimmune disease, thyroid disease, ART. Location: Bari, Italy Timeframe: January to December 2016
Interventions	Group I: 80 mg of Revifast®, 200 mg of myo‐inositol, 500 mg D‐chiro‐inositol Group II: 138 mg of myo‐inositol, 550 mg D‐chiro‐inositol. Duration of myo‐inositol supplementation: 60 days Group III: placebo (but not stated what placebo was)
Outcomes	Maternal: lipid profile (total cholesterol, LDL, HDL, triglycerides), glucose levels, blood pressure (systolic pressure and diastolic pressure) at baseline and after 30 and 60 days of therapy Criteria used to diagnose gestational diabetes: not stated Infant: not stated
Notes	Sample size calculation: not stated Funding source: no specific grant from any funding agency in the public, commercial, or not‐for‐profit sectors Conflict of interests: none reported Data collected in the form compares group 2 with group 3 (no revifast group (1) comparison) 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	A 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	The participants were blinded.
Blinding of outcome assessment (detection bias) All outcomes	Low risk	The outcome assessors were blinded.
Incomplete outcome data (attrition bias) All outcomes	Unclear risk	During the enrolment of 110 pregnant women, six patients were excluded: three left after the first visit, three did not meet inclusion criteria. The remaining 104 women have been allocated in the three groups as follows: 35 in group I, 34 in group II and 35 in group III. It seems that the randomization and allocation were conducted after excluding the 6 people, but the three participants who left after the first visit should be treated as lost to follow‐up. Analysis was conducted on the remaining 104 women.
Selective reporting (reporting bias)	Low risk	All outcome specified in the methods section have been reported.
Other bias	Low risk	The study appears to be free of other sources of bias. The authors do not report any potential conflicts of interest.