IGF-1, IGFBP3, ALS Normative Ranges in Healthy Pediatric Spanish Population

Overview

To determine the normative ranges of the Insulin-like Growth Factor 1 (IGF-1), Insulin-like growth factor-binding protein 3 (IGFBP-3), Acid-Labile Subunit (ALS) according to age, sex and pubertal stage of a healthy paediatric Spanish population.

Full Title of Study: “An Epidemiologic, Descriptive and Cross-sectional Study of the IGF-1, IGFBP-3 and ALS Normative Ranges in a Healthy Paediatric Spanish Population, Divided Into Chronological Age, Sex and Pubertal Stage”

Study Type

  • Study Type: Observational
  • Study Design
    • Time Perspective: Cross-Sectional
  • Study Primary Completion Date: October 2013

Clinical Trial Outcome Measures

Primary Measures

  • IGF-1 levels according to age, sex and pubertal stage in healthy paediatric volunteers
    • Time Frame: At the time of participant’s single study visit (day 1)

Secondary Measures

  • IGFBP-3 levels according to age, sex and pubertal stage in healthy paediatric volunteers
    • Time Frame: At the time of participant’s single study visit (day 1)
  • ALS levels according to age, sex and pubertal stage in healthy paediatric volunteers
    • Time Frame: At the time of participant’s single study visit (day 1)

Participating in This Clinical Trial

Inclusion Criteria

  • Children of either sex of Caucasian parents – Age: newborns up to and including 18 years of age – Length/height, weight and body mass index (BMI) within the mean +/- 2SD (Standard Deviation) and in accordance with the growth charts of the 2010 Spanish cross-sectional growth study (Carrascosa Lezcano et al 2010) – Signed consent by at least one parent or legal guardian (if subject is ≤18 years) and by subject if ≥12 years Exclusion Criteria:

  • Early or advanced puberty (pubertal signs: between 8 and 9 years old in girls, and between 9 and 10 years old in boys), or delayed puberty (no puberty onset in ≥ 13 year-old girls, and in ≥ 14 year-old boys) – Chronic diseases including, but not limited to, endocrinologic diseases, chromosomal diseases, chronic diseases of renal, hepatic and/or cardiac aetiology, and tumour processes – An acute disease during the last two weeks prior to recruitment – Any clinically significant out-of-range lab value – Healthy paediatric volunteers who are under medical treatment (contraception permitted) – A family history of short stature (either parent < P3) – Children born small for gestational age (birth weight, length, or head circumference < P10) – Adopted children or conceived through in vitro fertilization ( IVF ) – Subjects who are unwilling or unable in the opinion of the investigator or sponsor to undergo all the study procedures

Gender Eligibility: All

Minimum Age: N/A

Maximum Age: 18 Years

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • Ipsen
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Ipsen Medical Director, Study Director, Ipsen

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