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

NCT01676090 | Terminated

• 1 other identifier: A-92-52800-020
• Study Type: observational
• Target: 304
• Locations: 1 country
• Sites: 9

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.

Conditions

IGF-1 Deficiency

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• 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)

• ALS levels according to age, sex and pubertal stage in healthy paediatric volunteers

  At the time of participant's single study visit (day 1)

Eligibility Criteria

• Age: Up to 18 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Healthy paediatric Spanish population

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Ipsen: lead

Study Sites (9)

Fundación Sant Joan de Deu

Barcelona, Spain

Location

Hospital Universitari Vall d´Hebron

Barcelona, Spain

Location

Hospital de Cruces

Bilbao, Spain

Location

Hospital 12 de Octubre

Madrid, Spain

Location

Hospital Infantil Universitario Niño Jesús

Madrid, Spain

Location

Hospital Universitario La Paz

Madrid, Spain

Location

Hospital Clínico Universitario de Santiago de Compostela

Santiago de Compostela, Spain

Location

Hospital Universitario Nuestra Señora de Valme

Seville, Spain

Location

Hospital Miguel Servet

Zaragoza, Spain

Location

MeSH Terms

Conditions

Insulin-Like Growth Factor I Deficiency

Study Officials

• Ipsen Medical Director

  Ipsen

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 22, 2012
• First Posted: August 30, 2012
• Study Start: July 1, 2012
• Primary Completion: October 1, 2013
• Study Completion: October 1, 2013
• Last Updated: January 11, 2019

Record last verified: 2019-01

Locations

ES (9)