title: Complementary feeding: a Global Network cluster randomized controlled trial.
abstract: BACKGROUND
  Inadequate and inappropriate complementary feeding are major factors contributing to excess morbidity and mortality in young children in low resource settings. Animal source foods in particular are cited as essential to achieve micronutrient requirements. The efficacy of the recommendation for regular meat consumption, however, has not been systematically evaluated.
  
  
  METHODS
  A cluster randomized efficacy trial was designed to test the hypothesis that 12 months of daily intake of beef added as a complementary food would result in greater linear growth velocity than a micronutrient fortified equi-caloric rice-soy cereal supplement. The study is being conducted in 4 sites of the Global Network for Women's and Children's Health Research located in Guatemala, Pakistan, Democratic Republic of the Congo (DRC) and Zambia in communities with toddler stunting rates of at least 20%. Five clusters per country were randomized to each of the food arms, with 30 infants in each cluster. The daily meat or cereal supplement was delivered to the home by community coordinators, starting when the infants were 6 months of age and continuing through 18 months. All participating mothers received nutrition education messages to enhance complementary feeding practices delivered by study coordinators and through posters at the local health center. Outcome measures, obtained at 6, 9, 12, and 18 months by a separate assessment team, included anthropometry; dietary variety and diversity scores; biomarkers of iron, zinc and Vitamin B12 status (18 months); neurocognitive development (12 and 18 months); and incidence of infectious morbidity throughout the trial. The trial was supervised by a trial steering committee, and an independent data monitoring committee provided oversight for the safety and conduct of the trial.
  
  
  CONCLUSIONS
  Findings from this trial will test the efficacy of daily intake of meat commencing at age 6 months and, if beneficial, will provide a strong rationale for global efforts to enhance local supplies of meat as a complementary food for young children.
  
  
  BACKGROUND
  NCT01084109.
authors.affiliation: University of Colorado Denver, Aurora, CO, USA. nancy.krebs@ucdenver.edu
authors.forename: Nancy F
authors.initials: NF
authors.lastname: Krebs
authors.forename: K Michael
authors.initials: KM
authors.lastname: Hambidge
authors.forename: Manolo
authors.initials: M
authors.lastname: Mazariegos
authors.forename: Jamie
authors.initials: J
authors.lastname: Westcott
authors.forename: Norman
authors.initials: N
authors.lastname: Goco
authors.forename: Linda L
authors.initials: LL
authors.lastname: Wright
authors.forename: Marion
authors.initials: M
authors.lastname: Koso-Thomas
authors.forename: Antoinette
authors.initials: A
authors.lastname: Tshefu
authors.forename: Carl
authors.initials: C
authors.lastname: Bose
authors.forename: Omrana
authors.initials: O
authors.lastname: Pasha
authors.forename: Robert
authors.initials: R
authors.lastname: Goldenberg
authors.forename: Elwyn
authors.initials: E
authors.lastname: Chomba
authors.forename: Waldemar
authors.initials: W
authors.lastname: Carlo
authors.forename: Mark
authors.initials: M
authors.lastname: Kindem
authors.forename: Abhik
authors.initials: A
authors.lastname: Das
authors.forename: Ty
authors.initials: T
authors.lastname: Hartwell
authors.forename: Elizabeth
authors.initials: E
authors.lastname: McClure
mesh_terms: D000328:Adult; D000886:Anthropometry; D002657:Child Development; D003141:Communicable Diseases / Q000453:epidemiology; D015023:Democratic Republic of the Congo / Q000453:epidemiology; D019587:Dietary Supplements; D002523:Edible Grain; D005260:Female; D005527:Food, Fortified; D006130:Growth Disorders / Q000453:epidemiology / Q000209:etiology / Q000517:prevention & control; D006166:Guatemala / Q000453:epidemiology; D006266:Health Education; D006801:Humans; D007223:Infant; D007227:Infant Nutritional Physiological Phenomena; D044342:Malnutrition / Q000150:complications / Q000453:epidemiology / Q000517:prevention & control; D008460:Meat; D009035:Mothers / Q000523:psychology; D010154:Pakistan / Q000453:epidemiology; D010865:Pilot Projects; D015024:Zambia / Q000453:epidemiology