Huybregts 2009 (C).

Methods	A randomised, open‐label, community‐based clinical trial in the rural settings of Burkina Faso
Participants	Sample size: 1296 pregnant women enrolled; 32 women lost to follow‐up Mean age: 24.5 years Inclusion/exclusion criteria: women with suspected pregnancy were referred to the health centre for a formal pregnancy test and were included after confirmation of pregnancy. No exclusion criteria were used except that participants planning to leave the study area within the next 2 years were not eligible.
Interventions	Interventions Pregnant women were allocated to 2 groups: Group 1 (n = 641) received MMN tablets Group 2 (n = 655) received LNS Delivery/administration Home visitors kept both the MMN and fortified food supplement with them and visited 10 to 20 participants per day to provide and directly observe the supplement intake. LNS composition Energy: 1.56 MJ Energy from protein: 15.8% Energy from fat: 67.05% Carbohydrates: 15.9 g Protein: 14.7 g Fat: 27.6 g SFA: 8,1 g MUFA: 12.1 g PUFA: 7.3 g x3 fatty acids: 0.4 g x6 fatty acids: 7.0 g Total dietary fiber: 9.1 g Vitamin A: 881 RE Vitamin D: 200 IU Vitamin E: 13 mg Thiamin: 1.6 mg Riboflavin: 1.6 mg Niacin: 21 mg Vitamin B6: 2.0 mg Folate: 461 µg Vitamin B12: 2.6 µg Vitamin C: 71 mg Zinc: 17 mg Iron: 35 mg Copper: 2.7 mg Selenium: 65 µg Iodine: 150 µg Calcium: 90 mg
Outcomes	Primary outcomes Birth weight Birth length Secondary outcomes Low birth wight Small‐for‐gestational age Large‐for‐gestational age MUAC at birth and at 12 months of age Head circumference at birth and at 12 months of age Chest circumference at birth and at 12 months of age Anthropometric indices: weight‐for‐age z score, length‐for‐age z score, and weight‐for‐length z score at 12 months of age
Notes	Study duration: March 2006 to June 2008 Conflict of interest: authors declared that none of the authors had any potential conflicts of interest. Source of funding: Supported by Nutrition Third World, the Belgian Ministry of Development under agreement 96501, and the Flemish University Council under contract ZEIN2004PR298. None of the funders had any role in the study design, data collection, data analysis, or report writing.
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	Quote: "Individual randomisation was performed based on a computer‐generated program in permuted blocks of 4" Comment: adequately done
Allocation concealment (selection bias)	Low risk	Quote: "Randomization numbers were sealed in opaque envelopes and when an informed consent was obtained from an eligible participant, the study physician opened the next envelope and assigned the participant to a treatment group" Comment: adequately done
Blinding of participants and personnel (performance bias) All outcomes	Unclear risk	Quote: "We conducted a nonblinded, individually randomized controlled trial." Comment: not clear
Blinding of outcome assessment (detection bias) All outcomes	Unclear risk	Quote: "The study was organized as an open‐label" Comment: not clear
Incomplete outcome data (attrition bias) All outcomes	High risk	Comment: 150/641 (23%) lost to follow‐up in group 1; 164/655 (25%) lost to follow‐up in group 2
Selective reporting (reporting bias)	Low risk	Comment: all presented analyses were prespecified either in the trial protocol or in the statistical analysis plan registered at Clinical.Trials.gov as NCT00909974
Other bias	Low risk	Comment: no other sources of bias were identified. The study was supported by the Flemish University Council, Nutrition Third World, and the Belgian Ministry of Development. The multiple micronutrient premix was donated by Nutriset, France.