title: A micronutrient-fortified young-child formula improves the iron and vitamin D status of healthy young European children: a randomized, double-blind controlled trial.
abstract: Iron deficiency (ID) and vitamin D deficiency (VDD) are common among young European children because of low dietary intakes and low compliance to vitamin D supplementation policies. Milk is a common drink for young European children. Studies evaluating the effect of milk fortification on iron and vitamin D status in these children are scarce.
  
  
  
  We aimed to investigate the effect of a micronutrient-fortified young-child formula (YCF) on the iron and vitamin D status of young European children.
  
  
  
  In this randomized, double-blind controlled trial, healthy German, Dutch, and English children aged 1-3 y were allocated to receive either YCF (1.2 mg Fe/100 mL; 1.7 μg vitamin D/100 mL) or nonfortified cow milk (CM) (0.02 mg Fe/100 mL; no vitamin D) for 20 wk. Blood samples were taken before and after the intervention. The primary and secondary outcomes were change from baseline in serum ferritin (SF) and 25-hydroxyvitamin D [25(OH)D], respectively. ID was defined as SF <12 μg/L in the absence of infection (high-sensitivity C-reactive protein <10 mg/L) and VDD as 25(OH)D <50 nmol/L. Statistical adjustments were made in intention-to-treat analyses for sex, country, age, baseline micronutrient status, and micronutrient intake from food and supplements (and sun exposure in the case of vitamin D outcomes).
  
  
  
  The study sample consisted of 318 predominantly Caucasian (∼95%) children. The difference in the SF and 25(OH)D change between the treatment groups was 6.6 μg/L (95% CI: 1.4, 11.7 μg/L; P = 0.013) and 16.4 nmol/L (95% CI: 9.5, 21.4 nmol/L; P < 0.001), respectively. The probability of ID (OR 0.42; 95% CI:0.18, 0.95; P = 0.036) and VDD (OR 0.22; 95% CI: 0.01, 0.51; P < 0.001) after the intervention was lower in the YCF group than in the CM group.
  
  
  
  Micronutrient-fortified YCF use for 20 wk preserves iron status and improves vitamin D status in healthy young children in Western Europe. This trial was registered at www.trialregister.nl as NTR3609.
authors.affiliation: Department of Pediatrics, Juliana Children's Hospital/Haga Teaching Hospital, The Hague, Netherlands; m.d.akkermans@hagaziekenhuis.nl.
authors.forename: Marjolijn D
authors.identifier: 0000-0003-4642-4389
authors.initials: MD
authors.lastname: Akkermans
authors.affiliation: Danone Nutricia Research, Utrecht, Netherlands.
authors.forename: Simone Rbm
authors.initials: SR
authors.lastname: Eussen
authors.affiliation: Danone Nutricia Research, Utrecht, Netherlands.
authors.forename: Judith M
authors.initials: JM
authors.lastname: van der Horst-Graat
authors.affiliation: Danone Nutricia Research, Utrecht, Netherlands.|Department of Pediatrics, Emma Children's Hospital/Academic Medical Center, Amsterdam, Netherlands; and.
authors.forename: Ruurd M
authors.initials: RM
authors.lastname: van Elburg
authors.affiliation: Department of Pediatrics, Emma Children's Hospital/Academic Medical Center, Amsterdam, Netherlands; and.|Department of Pediatrics, VU University Medical Center, Amsterdam, Netherlands.
authors.forename: Johannes B
authors.initials: JB
authors.lastname: van Goudoever
authors.affiliation: Department of Pediatrics, Juliana Children's Hospital/Haga Teaching Hospital, The Hague, Netherlands.
authors.forename: Frank
authors.initials: F
authors.lastname: Brus
mesh_terms: D018798:Anemia, Iron-Deficiency / Q000097:blood / Q000188:drug therapy*; D000818:Animals; D002097:C-Reactive Protein / Q000378:metabolism; D002675:Child, Preschool; D004311:Double-Blind Method; D005060:Europe; D005260:Female; D005293:Ferritins / Q000097:blood; D005527:Food, Fortified; D006454:Hemoglobins / Q000378:metabolism; D006801:Humans; D007223:Infant; D041943:Infant Formula / Q000737:chemistry*; D007501:Iron / Q000008:administration & dosage / Q000097:blood; D000090463:Iron Deficiencies; D008297:Male; D018977:Micronutrients / Q000008:administration & dosage*; D008892:Milk / Q000737:chemistry; D009752:Nutritional Status; D014807:Vitamin D / Q000008:administration & dosage / Q000097:blood*; D014808:Vitamin D Deficiency / Q000097:blood / Q000188:drug therapy*; D044465:White People
chemical_list: D006454:Hemoglobins; D018977:Micronutrients; D014807:Vitamin D; D002097:C-Reactive Protein; D005293:Ferritins; D007501:Iron
keywords: cow milk; iron deficiency; micronutrient fortification; vitamin D deficiency; vitamin D supplements; young children; young-child formula