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. 2015 Nov 1;2015(11):CD004905. doi: 10.1002/14651858.CD004905.pub4
Methods This randomised trial was conducted in a socially deprived, multi‐ethnic population in east London, United Kingdom.
Participants Participants included women aged 16 years or older with a singleton pregnancy. Exclusion criteria included a gestation of greater than 13 weeks of gestation, chronic disease or use of micronutrient supplements (excluding folic acid and iron). MMN group n = 207 and placebo n = 195.
Interventions Participants were randomised to receive either MMN supplements, known as Pregnacare, or a placebo comprising starch with an iron oxide coating. MMN supplement contained beta‐carotene 3 mg, thiamin (as thiamin mononitrate, 3·6 mg) 3 mg, riboflavin 2 mg, niacin (as nicotinamide) 20 mg, vitamin B6 (as pyridoxine HCl) 10mg, vitamin B12 (as cyanocobalamin) 6 mcg, folic acid 400 mcg, vitamin C (as ascorbic acid, 73 mg) 70 mg, vitamin D (as cholecalciferol, 200 IU) 5 mcg, vitamin E (as D‐a‐tocopheryl acid succinate, 21 mg) 20 mg, vitamin K 70 mcg, Fe (as ferrous fumarate, 63·3 mg) 20 mg, zinc (as zinc sulphate H2O, 41 mg) 15 mg, Mg (as magnesium hydroxide, 372 mg) 150 mg, Iodine (as potassium iodide, 183 mg) 140 mcg and copper (as copper sulphate H2O, 2·8 mg) 1 mg.
Outcomes Birthweight, preterm birth, SGA, head circumference, Hb.
Notes Women not using folic acid were also given 400 mcg folic acid to take daily until 12 weeks of gestation.
There were no significant differences in age, height, weight, BMI or parity regarding treatment group allocation.
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Unclear risk Quote: "a randomised, double‐blind, placebo‐controlled trial" and "Participants were randomised to receive either multiple‐micronutrient supplements, known as Pregnacare, or a visually identical placebo".
Comment: insufficient information about the sequence generation process to permit judgement.
Allocation concealment (selection bias) Unclear risk Quote: "a randomised, double‐blind, placebo‐controlled trial".
Comment: insufficient information to permit judgement.
Incomplete outcome data (attrition bias) All outcomes Low risk Exclusion (8.7%) and attrition (12.2%) was reported along with their reasons.
Selective reporting (reporting bias) Low risk Comment: results of all outcomes mentioned in methods 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: "Participants were randomised to receive either multiple micronutrient supplements, known as Pregnacare, or visually identical placebo comprising starch with an iron oxide coating. All tablets were provided by Vitabiotics (London, UK) and packaged to allow double blinding. Only Vitabiotics knew the code and it was not broken until statistical analysis had been completed". Comment: participants and caregivers were probably blinded to the treatment assignment.
Blinding of outcome assessment (detection bias) All outcomes Low risk Quote: "All tablets were provided by Vitabiotics (London, UK) and packaged to allow double blinding. Only Vitabiotics knew the code and it was not broken until statistical analysis had been completed". Comment: outcome assessors were probably blinded to the treatment assignment.