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

Terminated

• Conditions: IGF-1 Deficiency

• Registration Number: NCT01676090
• Lead Sponsor: Ipsen

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-07
• Study First Submitted: 2012-08-22
• Study First Submitted QC: 2012-08-29
• Study First Posted: 2012-08-30
• Primary Completion: 2013-10
• Study Completion: 2013-10
• Status Verified: 2019-01
• Last Update Submitted: 2019-01-10
• Last Update Posted: 2019-01-11

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 304

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (9)

Hospital Universitari Vall d´Hebron; 🇪🇸 Barcelona, Spain

Hospital de Cruces; 🇪🇸 Bilbao, Spain

Hospital Universitario Nuestra Señora de Valme; 🇪🇸 Sevilla, Spain

Hospital Miguel Servet; 🇪🇸 Zaragoza, Spain

Hospital Clínico Universitario de Santiago de Compostela; 🇪🇸 Santiago de Compostela, Spain

Fundación Sant Joan de Deu; 🇪🇸 Barcelona, Spain

Hospital 12 de Octubre; 🇪🇸 Madrid, Spain

Hospital Infantil Universitario Niño Jesús; 🇪🇸 Madrid, Spain

Hospital Universitario La Paz; 🇪🇸 Madrid, Spain