title: Prenatal supplementation with Corn Soya Blend Plus reduces the risk of maternal anemia in late gestation and lowers the rate of preterm birth but does not significantly improve maternal weight gain and birth anthropometric measurements in rural Cambodian women: a randomized trial.
abstract: BACKGROUND
  Corn Soya Blend (CSB) Plus is a fortified dietary supplement used to help Cambodian women meet their nutritional requirements in pregnancy, although little is known about its ability to improve pregnancy outcomes.
  
  
  OBJECTIVE
  This study assessed the effect of prenatal CSB Plus supplementation on birth weight and secondary outcomes of low birth weight (<2500 g), small for gestational age, birth length and head circumference, preterm birth (<37 wk), maternal weight gain, and anemia at 24-28 wk, 30-32 wk, and 36-38 wk of gestation among rural Cambodian women.
  
  
  METHODS
  A cluster-randomized trial was conducted in 75 villages in Kampong Chhnang Province, in which 547 women received CSB Plus (treatment) during the first trimester until delivery or continued their normal diet (control) based on their village residence. All women received routine daily iron folic acid tablets and were treated with additional iron folic acid if they were anemic (hemoglobin <11 g/dL). Cluster-adjusted linear mixed-effect and logistic regression models were used to examine group differences.
  
  
  RESULTS
  There was no significant difference in birth weight between the CSB Plus and control group (46 g; 95% CI: -31, 123 g; P = 0.24). Significant reductions were observed in preterm birth (OR = 0.33; 95% CI: 0.12, 0.89) and anemia at 36-38 wk (OR = 0.51; 95% CI: 0.34, 0.77). There were no significant differences in low birth weight, small for gestational age, birth length, head circumference, or maternal weight gain. A higher rate of fetal loss was observed in the treatment group (10.2% compared with 3.7%; P < 0.01).
  
  
  CONCLUSIONS
  In Cambodian women, CSB Plus consumed during pregnancy did not significantly increase maternal weight gain or improve birth size but did reduce maternal anemia in late gestation and preterm birth in comparison with women consuming a normal diet. The unexpectedly higher rate of fetal loss in the treatment group is concerning and warrants further investigation. This trial was registered at clinicaltrials.gov as NCT01413776.
authors.affiliation: Department of Food, Nutrition and Health.
authors.forename: Amynah
authors.initials: A
authors.lastname: Janmohamed
authors.affiliation: Department of Food, Nutrition and Health.
authors.forename: Crystal D
authors.initials: CD
authors.lastname: Karakochuk
authors.affiliation: International Relief & Development, Cambodia Country Office, Phnom Penh, Cambodia.
authors.forename: Somchit
authors.initials: S
authors.lastname: Boungnasiri
authors.affiliation: Department of Food, Nutrition and Health.
authors.forename: Gwen E
authors.initials: GE
authors.lastname: Chapman
authors.affiliation: School of Population and Public Health and.
authors.forename: Patricia A
authors.identifier: http://orcid.org/0000-0002-4178-1195
authors.initials: PA
authors.lastname: Janssen
authors.affiliation: Department of Statistics, University of British Columbia, Vancouver, Canada, and.
authors.forename: Rollin
authors.initials: R
authors.lastname: Brant
authors.affiliation: Department of Food, Nutrition and Health.
authors.forename: Timothy J
authors.initials: TJ
authors.lastname: Green
authors.affiliation: Department of Food, Nutrition and Health, judy.mclean@ubc.ca.
authors.forename: Judy
authors.initials: J
authors.lastname: McLean
mesh_terms: D000022:Abortion, Spontaneous / Q000209:etiology; D000328:Adult; D000740:Anemia / Q000453:epidemiology / Q000517:prevention & control*; D001724:Birth Weight; D002160:Cambodia / Q000453:epidemiology; D016000:Cluster Analysis; D019587:Dietary Supplements / Q000009:adverse effects; D005260:Female; D005317:Fetal Growth Retardation / Q000453:epidemiology / Q000517:prevention & control; D006801:Humans; D007231:Infant, Newborn; D008297:Male; D039382:Maternal Nutritional Physiological Phenomena; D011247:Pregnancy; D011248:Pregnancy Complications / Q000453:epidemiology / Q000517:prevention & control*; D011261:Pregnancy Trimester, First; D047928:Premature Birth / Q000453:epidemiology / Q000517:prevention & control*; D012306:Risk; D012423:Rural Health; D045730:Soy Foods / Q000009:adverse effects; D015430:Weight Gain; D055815:Young Adult
keywords: Corn Soya Blend; fortified; maternal; pregnancy; supplementary food