IGF-1, IGFBP3, ALS Normative Ranges in Healthy Pediatric Spanish Population (NCT01676090) | Clinical Trial Compass
TerminatedNot Applicable
IGF-1, IGFBP3, ALS Normative Ranges in Healthy Pediatric Spanish Population
Stopped: Participant enrolment was lower than expected
Spain304 participantsStarted 2012-07
Plain-language 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.
Who can participate
Age range18 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
What they're measuring
1
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)