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

Ipsen

Status: Terminated

Conditions: IGF-1 Deficiency

Study type: Observational

Funder types: Industry

Identifiers

NCT01676090

A-92-52800-020

Details and patient eligibility

About

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.

Enrollment: 304 patients

Sex: All

Ages: Under 18 years old

Volunteers: Accepts Healthy Volunteers

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