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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Total Enrollment

304 participants

Study Classification

OBSERVATIONAL

Study Start Date

2012-07-31

Study Completion Date

2013-10-31

Brief Summary

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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.

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Detailed Description

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Conditions

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IGF-1 Deficiency

Study Design

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Observational Model Type

OTHER

Study Time Perspective

CROSS_SECTIONAL

Eligibility Criteria

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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

Maximum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes