title: Effect of Nutritional Supplementation on Growth in Short and Lean Prepubertal Children after 1 Year of Intervention.
abstract: To determine the 1-year effectiveness and safety of nutritional supplementation with the study formula on linear growth and weight gain in short and lean prepubertal children and to validate the previously reported findings in those initially treated with placebo.
  
  
  
  Two-phase 1-year intervention (double-blind placebo-controlled [0-6 months] and open-labeled extension [6-12 months]) in which all participants were offered to continue the study using the study formula. Anthropometric measures and 3-day food diary were assessed at baseline and after 6 and 12 months of intervention.
  
  
  
  A total of 129 out of 150 children (86%) completed the open-labeled extension-phase. In "good" consumers of the formula (intake ≥50% of recommended dose) throughout the entire year height-SDS continued to improve in the extension phase, with a total gain of 0.19 ± 0.14 SD. In "good" consumers of the formula initially randomized to the placebo-group, the gain in height-SDS significantly improved (from 0.04 ± 0.13 to 0.12 ± 0.11; P = .001), replicating the results of the "good" consumers of the formula during the blinded-phase (0.12 ± 0.12). "Poor" consumers (intake <50% of recommended dose) did not improve their height-SDS. No significant changes in body mass index SDS were observed with the consumption of the formula. A dose-response was found between the amount of formula consumed/kg and the increment in height-SDS and weight-SDS (r = 0.36; P < .001 and r = 0.18; P = .041, respectively). No serious adverse events were reported.
  
  
  
  One year of a nutritional supplement was effective in promoting the linear growth of short and lean prepubertal children, with no change in body mass index status.
  
  
  
  ClinicalTrials.gov:NCT01158352.
authors.affiliation: The Jesse Z and Sara Lea Shafer Institute for Endocrinology and Diabetes, National Center for Childhood Diabetes, Schneider Children's Medical Center of Israel, Petah Tikva, Israel.
authors.forename: Michal
authors.initials: M
authors.lastname: Yackobovitch-Gavan
authors.affiliation: The Jesse Z and Sara Lea Shafer Institute for Endocrinology and Diabetes, National Center for Childhood Diabetes, Schneider Children's Medical Center of Israel, Petah Tikva, Israel; Sackler Faculty of Medicine, Tel Aviv University, Tel Aviv, Israel.
authors.forename: Yael
authors.initials: Y
authors.lastname: Lebenthal
authors.affiliation: The Jesse Z and Sara Lea Shafer Institute for Endocrinology and Diabetes, National Center for Childhood Diabetes, Schneider Children's Medical Center of Israel, Petah Tikva, Israel; Sackler Faculty of Medicine, Tel Aviv University, Tel Aviv, Israel.
authors.forename: Liora
authors.initials: L
authors.lastname: Lazar
authors.affiliation: The Jesse Z and Sara Lea Shafer Institute for Endocrinology and Diabetes, National Center for Childhood Diabetes, Schneider Children's Medical Center of Israel, Petah Tikva, Israel; Sackler Faculty of Medicine, Tel Aviv University, Tel Aviv, Israel.
authors.forename: Shlomit
authors.initials: S
authors.lastname: Shalitin
authors.affiliation: The Jesse Z and Sara Lea Shafer Institute for Endocrinology and Diabetes, National Center for Childhood Diabetes, Schneider Children's Medical Center of Israel, Petah Tikva, Israel.
authors.forename: Sharon
authors.initials: S
authors.lastname: Demol
authors.affiliation: The Jesse Z and Sara Lea Shafer Institute for Endocrinology and Diabetes, National Center for Childhood Diabetes, Schneider Children's Medical Center of Israel, Petah Tikva, Israel; Sackler Faculty of Medicine, Tel Aviv University, Tel Aviv, Israel.
authors.forename: Ariel
authors.initials: A
authors.lastname: Tenenbaum
authors.affiliation: Sackler Faculty of Medicine, Tel Aviv University, Tel Aviv, Israel; Institute for Gastroenterology, Nutrition and Liver Diseases, Schneider Children's Medical Center of Israel, Petah Tikva, Israel.
authors.forename: Raanan
authors.initials: R
authors.lastname: Shamir
authors.affiliation: The Jesse Z and Sara Lea Shafer Institute for Endocrinology and Diabetes, National Center for Childhood Diabetes, Schneider Children's Medical Center of Israel, Petah Tikva, Israel; Sackler Faculty of Medicine, Tel Aviv University, Tel Aviv, Israel. Electronic address: mosheph@post.tau.ac.il.
authors.forename: Moshe
authors.initials: M
authors.lastname: Phillip
mesh_terms: D001827:Body Height; D002648:Child; D002664:Child Nutritional Physiological Phenomena; D002675:Child, Preschool; D019587:Dietary Supplements; D004311:Double-Blind Method; D005260:Female; D006128:Growth; D006801:Humans; D008297:Male; D011446:Prospective Studies; D013851:Thinness; D013997:Time Factors
keywords: linear growth; novel formula; nutritional supplementation