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Effect of Nutritional Supplementation on Growth in Short and Lean Prepubertal Children after 1 Year of Intervention
- Source :
- The Journal of Pediatrics. 179:154-159.e1
- Publication Year :
- 2016
- Publisher :
- Elsevier BV, 2016.
-
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.
- Subjects :
- Male
0301 basic medicine
Pediatrics
medicine.medical_specialty
Time Factors
Nutritional Supplementation
030209 endocrinology & metabolism
Growth
Placebo
03 medical and health sciences
0302 clinical medicine
Double-Blind Method
Thinness
Intervention (counseling)
Humans
Medicine
Prospective Studies
Child
Adverse effect
030109 nutrition & dietetics
business.industry
Anthropometry
medicine.disease
Body Height
Idiopathic short stature
Child, Preschool
Dietary Supplements
Pediatrics, Perinatology and Child Health
Female
medicine.symptom
Child Nutritional Physiological Phenomena
business
Weight gain
Body mass index
Subjects
Details
- ISSN :
- 00223476
- Volume :
- 179
- Database :
- OpenAIRE
- Journal :
- The Journal of Pediatrics
- Accession number :
- edsair.doi.dedup.....9264a976b043c41e7d5bbb03c32110c8