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

This study has been terminated.
(Participant enrolment was lower than expected)
Information provided by (Responsible Party):
Ipsen Identifier:
First received: August 22, 2012
Last updated: December 19, 2013
Last verified: December 2013
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.

IGF-1 Deficiency

Study Type: Observational
Study Design: Time Perspective: Cross-Sectional
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

Resource links provided by NLM:

Further study details as provided by Ipsen:

Primary Outcome Measures:
  • IGF-1 levels according to age, sex and pubertal stage in healthy paediatric volunteers [ Time Frame: At the time of participant's single study visit (day 1) ]

Secondary Outcome Measures:
  • IGFBP-3 levels according to age, sex and pubertal stage in healthy paediatric volunteers [ Time Frame: At the time of participant's single study visit (day 1) ]
  • ALS levels according to age, sex and pubertal stage in healthy paediatric volunteers [ Time Frame: At the time of participant's single study visit (day 1) ]

Enrollment: 304
Study Start Date: July 2012
Study Completion Date: October 2013
Primary Completion Date: October 2013 (Final data collection date for primary outcome measure)

Ages Eligible for Study:   up to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Healthy paediatric Spanish population

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
  Contacts and Locations
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Please refer to this study by its identifier: NCT01676090

Fundación Sant Joan de Deu
Barcelona, Spain
Hospital Universitari Vall d´Hebron
Barcelona, Spain
Hospital de Cruces
Bilbao, Spain
Hospital 12 de Octubre
Madrid, Spain
Hospital Infantil Universitario Niño Jesús
Madrid, Spain
Hospital Universitario La Paz
Madrid, Spain
Hospital Clínico Universitario de Santiago de Compostela
Santiago de Compostela, Spain
Hospital Universitario Nuestra Señora de Valme
Sevilla, Spain
Hospital Miguel Servet
Zaragoza, Spain
Sponsors and Collaborators
Study Director: Elena Hernandez Yuste Ipsen
  More Information

Responsible Party: Ipsen Identifier: NCT01676090     History of Changes
Other Study ID Numbers: A-92-52800-020
Study First Received: August 22, 2012
Last Updated: December 19, 2013 processed this record on May 25, 2017