IGF-1, IGFBP3, ALS Normative Ranges in Healthy Pediatric Spanish Population (EDISON)
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ClinicalTrials.gov Identifier: NCT01676090
(Participant enrolment was lower than expected)
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.
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 Start Date
Primary Completion Date
Study Completion Date
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Ages Eligible for Study:
up to 18 Years (Child, Adult)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
Healthy paediatric Spanish population
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
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