title: A Randomized Trial of Iron-Biofortified Pearl Millet in School Children in India.
abstract: BACKGROUND
  Iron deficiency is the most widespread nutritional deficiency in the world.
  
  
  OBJECTIVE
  The objective of this randomized efficacy trial was to determine the effects of iron-biofortified pearl millet (Fe-PM) on iron status compared with control pearl millet (Control-PM).
  
  
  METHODS
  A randomized trial of biofortified pearl millet (Pennisetum glaucum), bred to enhance iron content, was conducted in 246 children (12-16 y) for 6 mo in Maharashtra, India. Iron status [hemoglobin, serum ferritin (SF), soluble transferrin receptor (sTfR), and total body iron (TBI)], inflammation (C-reactive protein and α-1 acid glycoprotein), and anthropometric indices were evaluated at enrollment and after 4 and 6 mo. Hodges-Lehmann-Sen 95% CIs were used to examine the effect of the Fe-PM on iron status compared with commercially available Control-PM. Linear and binomial regression models were used to evaluate the effects of Fe-PM on iron status and incidence of anemia and iron deficiency, compared with Control-PM.
  
  
  RESULTS
  At baseline, 41% of children were iron deficient (SF <15 μg/L) and 28% were anemic (hemoglobin <12.0 g/dL). Fe-PM significantly increased SF concentrations and TBI after 4 mo compared with Control-PM. Among children who were iron deficient at baseline, those who received Fe-PM were 1.64 times more likely to become iron replete by 6 mo than were those receiving Control-PM (RR: 1.64, 95% CI: 1.07, 2.49, P = 0.02). The effects of Fe-PM on iron status were greater among children who were iron deficient at baseline than among children who were not iron deficient at baseline.
  
  
  CONCLUSIONS
  Fe-PM significantly improved iron status in children by 4 mo compared with Control-PM. This study demonstrated that feeding Fe-PM is an efficacious approach to improve iron status in school-age children and it should be further evaluated for effectiveness in a broader population context. This trial was registered at clinicaltrials.gov as NCT02152150.
authors.affiliation: Division of Nutritional Sciences, Cornell University, Ithaca, NY;
authors.forename: Julia L
authors.identifier: http://orcid.org/0000-0001-9512-5559
authors.initials: JL
authors.lastname: Finkelstein
authors.affiliation: Division of Nutritional Sciences, Cornell University, Ithaca, NY;
authors.forename: Saurabh
authors.identifier: http://orcid.org/0000-0003-3788-0665
authors.initials: S
authors.lastname: Mehta
authors.affiliation: S.N.D.T. Women's University, Mumbai, India;
authors.forename: Shobha A
authors.initials: SA
authors.lastname: Udipi
authors.affiliation: S.N.D.T. Women's University, Mumbai, India;
authors.forename: Padmini S
authors.initials: PS
authors.lastname: Ghugre
authors.affiliation: Division of Nutritional Sciences, Cornell University, Ithaca, NY;
authors.forename: Sarah V
authors.initials: SV
authors.lastname: Luna
authors.affiliation: Division of Nutritional Sciences, Cornell University, Ithaca, NY; University of Oklahoma, Norman, OK; and.
authors.forename: Michael J
authors.initials: MJ
authors.lastname: Wenger
authors.affiliation: The Pennsylvania State University, University Park, PA.
authors.forename: Laura E
authors.initials: LE
authors.lastname: Murray-Kolb
authors.affiliation: Division of Nutritional Sciences, Cornell University, Ithaca, NY;
authors.forename: Eric M
authors.initials: EM
authors.lastname: Przybyszewski
authors.affiliation: Division of Nutritional Sciences, Cornell University, Ithaca, NY; jdh12@cornell.edu.
authors.forename: Jere D
authors.identifier: http://orcid.org/0000-0002-4624-8488
authors.initials: JD
authors.lastname: Haas
mesh_terms: D000293:Adolescent; D018798:Anemia, Iron-Deficiency / Q000097:blood / Q000178:diet therapy; D002097:C-Reactive Protein / Q000378:metabolism; D002648:Child; D004311:Double-Blind Method; D005260:Female; D005293:Ferritins / Q000097:blood; D005500:Follow-Up Studies; D005527:Food, Fortified; D006454:Hemoglobins / Q000378:metabolism; D006801:Humans; D007194:India; D019266:Iron, Dietary / Q000008:administration & dosage* / Q000097:blood; D016014:Linear Models; D008297:Male; D009752:Nutritional Status; D009961:Orosomucoid / Q000378:metabolism; D031782:Pennisetum / Q000737:chemistry*; D011446:Prospective Studies; D011990:Receptors, Transferrin / Q000097:blood; D016896:Treatment Outcome
chemical_list: D006454:Hemoglobins; D019266:Iron, Dietary; D009961:Orosomucoid; D011990:Receptors, Transferrin; D002097:C-Reactive Protein; D005293:Ferritins
keywords: India; anemia; biofortification; children; international nutrition; iron