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. 2015 Nov 1;2015(11):CD004905. doi: 10.1002/14651858.CD004905.pub4
Methods A double‐blind, randomised placebo‐controlled trial. The study was conducted at Obstetric Departments of Grenoble and Lyon Hospitals in France.
Participants A total of 100 apparently healthy women receiving prenatal care between 12 and 16 weeks of gestation were enrolled.
Interventions The intervention group received a MMN supplement and the control group received a placebo. The MMN supplement contained vitamin C (60 mg), b‐carotene (4.8 mg), vitamin E (10 mg), thiamin (1.4 mg), riboflavin (1.6 mg), niacin (15 mg), pantothenic acid (6 mg), folic acid (200 mg), cobalamin (1 mg), Zn (15mg as citrate), Mg (87.5 mg as glycerophosphate), Ca (100 mg as carbonate). The supplement was given for an average of 14 ± 2 weeks of gestation till delivery.
Outcomes Effect of MMN supplementation on maternal blood vitamin concentrations, mineral and trace element concentrations and oxidative stress indexes concentrations. Maternal weight gain, gestational age of baby at birth, birthweight and head circumference were also assessed.
Notes The MMN supplement was iron‐free, due to its oxidative potential effect. Baseline characteristics and vitamin mineral status of the enrolled participants were comparable in both groups. Outcomes measured were presented in a format that precluded its inclusion in this review.
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Unclear risk Quote: "Pregnant women were randomly assigned" and "randomized, placebo‐controlled trial".
Comment: method used to generate the randomisation sequence is not described in sufficient detail to permit judgement.
Allocation concealment (selection bias) Unclear risk Comment: insufficient information to permit judgment.
Incomplete outcome data (attrition bias) All outcomes High risk Reasons for attrition (35%) were not described in the study. There were no exclusions reported.
Selective reporting (reporting bias) Low risk Comment: all outcomes in the methods section were presented in the paper.
Other bias Low risk comment: no other bias was identified.
Blinding of participants and personnel (performance bias) All outcomes Low risk Quote: "The subjects, the hospital staff and the investigators were blinded to the coding scheme until analyses of the data were completed". Comment: participants and caregivers were blinded to the treatment assignment.
Blinding of outcome assessment (detection bias) All outcomes Low risk Quote: "The subjects, the hospital staff and the investigators were blinded to the coding scheme until analyses of the data were completed". Comment: outcome assessors were blinded to the treatment assignment.