Roberfroid 2008

Methods	This was a factorial, double‐blind, randomised controlled trial from March 2004 to October 2006 in the Hounde health district of Burkina Faso.
Participants	Pregnant women irrespective of gestational age. Exclusion criterion was if women planned to leave area within 2 years.
Interventions	Intervention group (n = 714) received vitamin A 800 mcg, D 200 IU, E 10 mg, B1 1.4 mg, B2 1.4 mg, niacin 18 mg, folic acid 400 mg, B6 1.9 mg, B12 2.6 mcg, C 70 mg, zinc 15 mg, iron 30 mg, copper 2 mg, selenium 65 mcg, iodine 150 mcg. Placebo group (n = 712) received folic acid 400 mcg and iron 60 mg.
Outcomes	Stillbirths (fetal death between 28 weeks of gestation till birth), neonatal deaths, perinatal death, gestation age, preterm births (< 37 weeks of gestation), birthweight, LBW (< 2500 g), SGA (birthweight less than 10 percentile of a reference population), LGA, birth length, Rohrer index, arm circumference, chest circumference, head circumference, Hb in cord blood, soluble serum transferrin receptor, stunting, wasting, underweight, and infant mortality during the first year of life. It should be noted that the data for SGA was obtained from a separate report (Food and Nutrition Bulletin 2009) and not from the individual trial report.
Notes	Supplement intake was observed directly and were given till 3 months after delivery. Participants were also randomly assigned to receive either malaria chemoprophylaxis (300 mg cholorquine/week) or intermittent preventive treatment (1500 mg sulfadoxine and 75 mg pyrimethamine once in the second and third trimester). All participants received albendazole 400 mg during second and third trimester. Severely anaemic women received ferrous sulphate 200 mg and folic acid 0.25 mg twice daily for 3 months regardless of their allocation groups. The study groups were similar with respect to baseline characteristics except for small difference in Hb (lower in intervention group) and BMI (lower in control group). Stunting, wasting, underweight, and infant mortality during the first year of life were presented as hazard ratios and could not be included in the analysis of outcome using risk ratios.
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	Quote: "The randomization scheme was generated by a computer program in permuted blocks of 4". Comment: probably done.
Allocation concealment (selection bias)	Low risk	Quote: "Randomization numbers were sealed in opaque envelopes. At each inclusion, the consulting physician opened the next sealed envelope and transmitted the randomisation number to a pharmacist managing the allocation sequence and the packaging of drugs in Center Muraz. The pharmacist was also blinded to the intervention. Individual plastic zip bags contained 31 tablets each and were labelled with the participant’s name, address, and identification numbers only". Comment: probably done.
Incomplete outcome data (attrition bias) All outcomes	Low risk	Attrition was 7.5% and reason for it was provided. Only 1 woman was excluded because of therapeutic abortion.
Selective reporting (reporting bias)	Low risk	Comment: all outcomes mentioned 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: "double blind", "Intervention and control micronutrient tablets were identical in appearance" and "code was kept secret from study participants and staff until completion of preliminary data analysis" and "Pharmacist was also blinded to the intervention". Comment: participants and caregivers were probably blinded to the treatment assignment.
Blinding of outcome assessment (detection bias) All outcomes	Low risk	Quote: "double blind", "Intervention and control micronutrient tablets were identical in appearance" and "code was kept secret from study participants and staff until completion of preliminary data analysis" and "Pharmacist was also blinded to the intervention". Comment: outcome assessors were probably blinded to the treatment assignment.