Resources

Clinical trials

The study is registered on Clinical Trials: NCT03533712

Study protocol

Study protocol can be found here.

Procedures

• Inclusion
• Ultrasound measurements
• Baseline survey
• Antenatal care visits
• Delivery
• Follow-up of children 
• Home visits
• Support to the maternities
• 24-hour recall questionnaire

Statistical analysis plan

• Download SAP version 1 here (dd October 24, 2019)

Publication List 

• Hanley-Cook G et al. Prenatal multiple micronutrient-fortified balanced energy-protein supplementation and newborn telomere lenght and mitochondrial DNA content: a randomized controlled efficacy trial in rural Burkina Faso 2023 MEDRXIV 
• Bastos-Moreira Y et al. Prenatal ochratoxin A exposure, birth outcomes and infant growth in rural Burkina Faso: a human biomonitoring sub-study from the MISAME-III trial 2024 Emerging contaminants 10(4)
• Bastos-Moreira Y et al. A Multi-Omics and Human Biomonitoring Approach to Assessing the Effectiveness of Fortified Balanced Energy–Protein Supplementation on Maternal and Newborn Health in Burkina Faso: A Study Protocol Nutrients 2023, 15, 4056. https://doi.org/10.3390/nu15184056
• Argaw A (2023) Effect of prenatal micronutrient-fortified balanced energy-protein supplementation on maternal and newborn body composition: A sub-study from the MISAME-III randomized controlled efficacy trial in rural Burkina Faso. PloSMed
• Argaw A et al (2023) Fortified balanced energy protein supplementation during pregancy and lactation and infant growth in rural Burkina Faso: A 2x2 factorial individually randomized controlled trial. PloSMed 
• Hanley-Cook G. et al (2022) Seasonality and Day-to-Day Variability of Dietary Diversity : Longitudinal Study of Pregnant Women Enrolled in a Randomized Controlled Efficacy Trial in Rural Burkina Faso.” The journal of Nutrition, vol. 152, no. 9, 2022, pp. 2145–54, doi:10.1093/jn/nxac104
• Hanley-Cook G. et al (2022) Fortified Balanced Energy-Protein Supplementation, Maternal Anemia, and Gestational Weight Gain: a Randomized Controlled Efficacy Trial Among Pregnant Women in Rural Burkina Faso. The Journal of Nutrition, nxac171, 
• de Kok et al. (2022) Prenatal fortified balanced energy-protein supplementation and birth outcomes in rural Burkina Faso: a randomised controlled efficacy trial Plos Med
• de Kok et al. (2021) Fortified balanced energy-protein supplements increase nutrient adequacy without displacing food intake in pregnant women in rural Burkina Faso. Journal of Nutrition
• Vanslambrouck et al. (2021) Effect of balanced energy-protein supplementation during pregancy and lactation on birth outcomes and infant growth in rural Burkina Faso: study protocol for a randomised controlled trial. BMJopen 11:e038393. doi: 10.1136/bmjopen-2020-038393
• de Kok, B., Moore, K., Jones, L., Vanslambrouck, K., Toe, L., Ouédraogo, M., Ganaba, R., De Pee, S., Bedford, J., Lachat, C., Kolsteren, P., Isanaka S. (2021). Home consumption of two fortified balanced energy protein supplements by pregnant women in Burkina Faso. Maternal and Child Nutrition . e13134
• Jones, L., de Kok, B., Moore, K., de Pee, S., Bedford, J., Vanslambrouck, K., ... & Isanaka, S. (2020). Acceptability of 12 fortified balanced energy protein supplements‐Insights from Burkina Faso. Maternal & Child Nutrition, e13067.

Previous papers that involved the consortium, MISAME I and MISAME II

• Allen, L.H. and Peerson J.M., Impact of multiple micronutrient versus iron-folic acid supplements on maternal anemia and micronutrient status in pregnancy. Food Nutr Bull, 2009. 30(4 Suppl): p. S527-32.
• Christian, P., et al., Risk of childhood undernutrition related to small-for-gestational age and preterm birth in low- and middle-income countries. Int J Epidemiol, 2013. 42(5): p. 1340-55.
• Fall, C.H., et al., Multiple micronutrient supplementation during pregnancy in low-income countries: a meta-analysis of effects on birth size and length of gestation. Food Nutr Bull, 2009. 30(4 Suppl): p. S533-46.
• Huybregts, L., et al., Prenatal food supplementation fortified with multiple micronutrients increases birth length: a randomized controlled trial in rural Burkina Faso. Am J Clin Nutr, 2009. 90(6): p. 1593-600.
• Huybregts, L., et al., Prenatal lipid-based nutrient supplements increase cord leptin concentration in pregnant women from rural Burkina Faso. J Nutr, 2013. 143(5): p. 576-83.
• Huybregts, L., et al., Validity of photographs for food portion estimation in a rural West African setting. Public Health Nutr, 2008. 11(6): p. 581-7.
• Huybregts, L.F., et al., Dietary behaviour, food and nutrient intake of pregnant women in a rural community in Burkina Faso. Matern Child Nutr, 2009. 5(3): p. 211-22.
• Katz, J., et al., Mortality risk in preterm and small-for-gestational-age infants in low-income and middle-income countries: a pooled country analysis. Lancet, 2013. 382(9890): p. 417-425.
• Kozuki, N., et al., Comparison of US Birth Weight References and the International Fetal and Newborn Growth Consortium for the 21st Century Standard. JAMA Pediatr, 2015. 169(7): p. e151438.
• Kozuki, N., et al., Short Maternal Stature Increases Risk of Small-for-Gestational-Age and Preterm Births in Low- and Middle-Income Countries: Individual Participant Data Meta-Analysis and Population Attributable Fraction. J Nutr, 2015. 145(11): p. 2542-50.
• Lanou, H., et al., Prenatal nutrient supplementation and postnatal growth in a developing nation: an RCT. Pediatrics, 2014. 133(4): p. e1001-8.
• Lee, A.C., et al., Estimates of burden and consequences of infants born small for gestational age in low and middle income countries with INTERGROWTH-21(st) standard: analysis of CHERG datasets. Bmj, 2017. 358: p. j3677.
• Lee, A.C., et al., National and regional estimates of term and preterm babies born small for gestational age in 138 low-income and middle-income countries in 2010. Lancet Glob Health, 2013. 1(1): p. e26-36.
• Margetts, B.M., et al., Multiple micronutrient supplementation during pregnancy in low-income countries: review of methods and characteristics of studies included in the meta-analyses. Food Nutr Bull, 2009. 30(4 Suppl): p. S517-26.
• Roberfroid, D., et al., Effects of maternal multiple micronutrient supplementation on fetal growth: a double-blind randomized controlled trial in rural Burkina Faso. Am J Clin Nutr, 2008. 88(5): p. 1330-40.
• Roberfroid, D., et al., Impact of prenatal multiple micronutrients on survival and growth during infancy: a randomized controlled trial. Am J Clin Nutr, 2012. 95(4): p. 916-24.
• Roberfroid, D., et al., Prenatal micronutrient supplements cumulatively increase fetal growth. J Nutr, 2012. 142(3): p. 548-54.
• Roberfroid, D., et al., Randomized controlled trial of 2 prenatal iron supplements: is there a dose-response relation with maternal hemoglobin? Am J Clin Nutr, 2011. 93(5): p. 1012-8.
• Ronsmans, C., et al., Multiple micronutrient supplementation during pregnancy in low-income countries: a meta-analysis of effects on stillbirths and on early and late neonatal mortality. Food Nutr Bull, 2009. 30(4 Suppl): p. S547-55.
• Smith, E.R., et al., Modifiers of the effect of maternal multiple micronutrient supplementation on stillbirth, birth outcomes, and infant mortality: a meta-analysis of individual patient data from 17 randomised trials in low-income and middle-income countries. Lancet Glob Health, 2017. 5(11): p. e1090-e1100.
• Toe, L.C., et al., Seasonality modifies the effect of a lipid-based nutrient supplement for pregnant rural women on birth length. J Nutr, 2015. 145(3): p. 634-9.
• Valea, I., et al., An analysis of timing and frequency of malaria infection during pregnancy in relation to the risk of low birth weight, anaemia and perinatal mortality in Burkina Faso. Malar J, 2012. 11: p. 71.
• Valea, I., et al., Intermittent preventive treatment of malaria with sulphadoxine-pyrimethamine during pregnancy in Burkina Faso: effect of adding a third dose to the standard two-dose regimen on low birth weight, anaemia and pregnancy outcomes. Malar J, 2010. 9: p. 324.