Clinical trial NCT01676090: IGF-1, IGFBP3, ALS Normative Ranges in Healthy Pediatric Spanish Population
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
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: IGF-1 Deficiency
Lead sponsor: Ipsen
Sponsor class: INDUSTRY
First posted: 2012-08-30
Enrollment: 304
Sex: ALL
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Healthy paediatric Spanish population

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.


Eligibility criteria: 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

Primary outcomes:
measure: IGF-1 levels according to age, sex and pubertal stage in healthy paediatric volunteers
timeFrame: At the time of participant's single study visit (day 1)
Secondary outcomes:
measure: IGFBP-3 levels according to age, sex and pubertal stage in healthy paediatric volunteers
timeFrame: At the time of participant's single study visit (day 1)
measure: ALS levels according to age, sex and pubertal stage in healthy paediatric volunteers
timeFrame: At the time of participant's single study visit (day 1)
Other outcomes:
Locations:
city: Barcelona
country: Spain
facility: Fundación Sant Joan de Deu
city: Barcelona
country: Spain
facility: Hospital Universitari Vall d´Hebron
city: Bilbao
country: Spain
facility: Hospital de Cruces
city: Madrid
country: Spain
facility: Hospital 12 de Octubre
city: Madrid
country: Spain
facility: Hospital Infantil Universitario Niño Jesús
city: Madrid
country: Spain
facility: Hospital Universitario La Paz
city: Santiago de Compostela
country: Spain
facility: Hospital Clínico Universitario de Santiago de Compostela
city: Sevilla
country: Spain
facility: Hospital Universitario Nuestra Señora de Valme
city: Zaragoza
country: Spain
facility: Hospital Miguel Servet
Study officials:
affiliation: Ipsen
name: Ipsen Medical Director
role: STUDY_DIRECTOR
References: