Adu‐Afarwuah 2015.
Methods | Randomised, single‐blind, parallel group, community‐based clinical trial in Ghana | |
Participants |
Sample size: 1320 pregnant women and 1228 infants enrolled; 263 pregnant women excluded due to mixed exposure Mean age: 26.6 years Inclusion/exclusion criteria: pregnant women ≥ 18 years of age and ≤ 20 weeks of gestation, and children aged 6 months to 18 months were eligible. Women were excluded if their antenatal cards indicated HIV infection, asthma, epilepsy, tuberculosis, or any malignancy. Additional exclusion criteria were known milk or peanut allergy, not residing in the area, intention to move within the next 2 years, unwillingness to receive field workers or take the study supplement, or participation in another trial. |
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Interventions |
Interventions Pregnant women were allocated to 3 groups:
Delivery/administration At enrolment, each woman received a 2‐week supply of supplement (including instruction to consume one capsule with water after a meal or one sachet mixed with any food each day), a standard nutrition message (quote: "Do not forget to eat meat, fish, eggs, fruits, and vegetables whenever you can; you still need these foods even as you take the supplement we have given you"), and a sticker on her antenatal card for identification. LNS composition Ration: 20 g/d Total energy: 118 kcal Protein: 2.6 g Fat: 10 g Linoleic acid: 4.59 g α‐Linolenic acid: 0.59 g Vitamin A: 800 µg RE Vitamin C: 100 mg Vitamin B1: 2.8 mg Vitamin B2: 2.8 mg Niacin: 36 mg Folic acid: 400 µg Pantothenic acid: 77 mg Vitamin B6: 3.8 mg Vitamin B12: 5.2 µg Vitamin D: 400 IU Vitamin E: 20 mg Vitamin K: 45 µg Iron: 20 mg Zinc: 30 mg Copper: 4 mg Calcium: 280 mg Phosphorus: 190 mg Potassium: 200 mg Magnesium: 65 mg Selenium: 130 µg Iodine: 250 µg Manganese: 2.6 mg |
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Outcomes |
Primary outcomes
Secondary outcomes
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Notes |
Study duration: December 2009 to March 2014 Conflict of interest: authors declared that they had no conflicts of interest related to this study. Source of funding: Bill & Melinda Gates Foundation. The funder of the study had no role in the study design; data collection, analysis, and interpretation; or the preparation of the manuscript. |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk |
Quote: "The study statistician at University of California, Davis developed group allocations with the use of a computer‐generated (SAS version 9.3; SAS Institute) randomisation scheme in blocks of 9" Comment: adequately done |
Allocation concealment (selection bias) | Low risk |
Quote: "The study nurse offered sealed, opaque envelopes bearing group allocations, 9 envelopes at a time, and the woman picked one to reveal the allocation. Allocation information was kept securely by the field supervisor and the study statistician only." Comment: adequately done |
Blinding of participants and personnel (performance bias) All outcomes | Unclear risk | Comment: it was not possible to blind the field workers and study participants to those consuming capsules versus LNS (because of the starkly different characteristics). |
Blinding of outcome assessment (detection bias) All outcomes | Low risk |
Quote: "Laboratory staff, anthropometrists, and data analysts had no knowledge of group assignment until all preliminary analyses had been completed" Comment: adequately done |
Incomplete outcome data (attrition bias) All outcomes | Low risk | Comment: in IFA arm: 15/408 (3.7%) lost to follow‐up; in MMN arm: 10/411 (2.4%) lost to follow‐up; in LNS arm: 18/409 (4.4%) lost to follow‐up |
Selective reporting (reporting bias) | Low risk | Comment: registered at ClinicalTrials.gov as NCT00970866. Statistical analysis plan was posted before (www.ilins.org) and all presented analyses were prespecified in the statistical analysis plan; adequately done |
Other bias | Low risk | Comment: no other sources of bias were identified. The study was funded by the Bill & Melinda Gates Foundation. |