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

This study has been terminated.
(Participant enrolment was lower than expected)
Sponsor:
Information provided by (Responsible Party):
Ipsen
ClinicalTrials.gov Identifier:
NCT01676090
First received: August 22, 2012
Last updated: December 19, 2013
Last verified: December 2013
  Purpose

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.


Condition
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) ] [ Designated as safety issue: No ]

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) ] [ Designated as safety issue: No ]
  • 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) ] [ Designated as safety issue: No ]

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)
  Eligibility

Ages Eligible for Study:   up to 18 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

Healthy paediatric Spanish population

Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01676090

Locations
Spain
Fundación Sant Joan de Deu
Barcelona, Spain
Hospital Universitari Vall d´Hebron
Barcelona, Spain
Hospital de Cruces
Bilbao, Spain
Hospital Infantil Universitario Niño Jesús
Madrid, Spain
Hospital 12 de Octubre
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
Ipsen
Investigators
Study Director: Elena Hernandez Yuste Ipsen
  More Information

No publications provided

Responsible Party: Ipsen
ClinicalTrials.gov Identifier: NCT01676090     History of Changes
Other Study ID Numbers: A-92-52800-020
Study First Received: August 22, 2012
Last Updated: December 19, 2013
Health Authority: Spain: Agencia Española de Medicamentos y Productos Sanitarios

Additional relevant MeSH terms:
Growth Disorders
Hearing Loss, Sensorineural
Pathologic Processes
Hearing Loss
Hearing Disorders
Ear Diseases
Otorhinolaryngologic Diseases
Sensation Disorders
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms

ClinicalTrials.gov processed this record on August 18, 2014