A Randomized Trial of Iron-Biofortified Pearl Millet in School Children in India

J Nutr. 2015 Jul;145(7):1576-81. doi: 10.3945/jn.114.208009. Epub 2015 May 6.

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.

Keywords: India; anemia; biofortification; children; international nutrition; iron.

Publication types

  • Randomized Controlled Trial
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Adolescent
  • Anemia, Iron-Deficiency / blood
  • Anemia, Iron-Deficiency / diet therapy
  • C-Reactive Protein / metabolism
  • Child
  • Double-Blind Method
  • Female
  • Ferritins / blood
  • Follow-Up Studies
  • Food, Fortified*
  • Hemoglobins / metabolism
  • Humans
  • India
  • Iron, Dietary / administration & dosage*
  • Iron, Dietary / blood
  • Linear Models
  • Male
  • Nutritional Status
  • Orosomucoid / metabolism
  • Pennisetum / chemistry*
  • Prospective Studies
  • Receptors, Transferrin / blood
  • Treatment Outcome

Substances

  • Hemoglobins
  • Iron, Dietary
  • Orosomucoid
  • Receptors, Transferrin
  • C-Reactive Protein
  • Ferritins

Associated data

  • ClinicalTrials.gov/NCT02152150