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

Status

Terminated

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01676090

Acronym

EDISON

Enrollment

304

Registered

2012-08-30

Start date

2012-07-31

Completion date

2013-10-31

Last updated

2019-01-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

IGF-1 Deficiency

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.

Interventions

None listed

Study design

Observational model

OTHER

Time perspective

CROSS_SECTIONAL

Eligibility

Sex/Gender

ALL

Age

No minimum to 18 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame
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

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

Countries

Spain

Outcome results