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

IGF-1 Deficiency Clinical Trial

— EDISON  

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01676090
• Other study ID #: A-92-52800-020
• Status: Terminated
• Start date: July 2012
• Est. completion date: October 2013

Study information

• Verified date: January 2019
• Source: Ipsen
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 304
• Est. completion date: October 2013
• Est. primary completion date: October 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A to 18 Years

Eligibility

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

Related Conditions & MeSH terms

• IGF-1 Deficiency

Locations

Country	Name	City	State
Spain	Fundación Sant Joan de Deu	Barcelona
Spain	Hospital Universitari Vall d´Hebron	Barcelona
Spain	Hospital de Cruces	Bilbao
Spain	Hospital 12 de Octubre	Madrid
Spain	Hospital Infantil Universitario Niño Jesús	Madrid
Spain	Hospital Universitario La Paz	Madrid
Spain	Hospital Clínico Universitario de Santiago de Compostela	Santiago de Compostela
Spain	Hospital Universitario Nuestra Señora de Valme	Sevilla
Spain	Hospital Miguel Servet	Zaragoza

Sponsors (1)

Lead Sponsor	Collaborator
Ipsen

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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)
Secondary	ALS levels according to age, sex and pubertal stage in healthy paediatric volunteers		At the time of participant's single study visit (day 1)