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

January 10, 2019 updated by: Ipsen

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

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.

Study Overview

Status

Terminated

Conditions

Study Type

Observational

Enrollment (Actual)

304

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
      • Barcelona, Spain
        • Hospital Universitari Vall d´Hebrón
      • Barcelona, Spain
        • Fundación Sant Joan de Deu
      • Bilbao, Spain
        • Hospital de Cruces
      • Madrid, Spain
        • Hospital 12 de Octubre
      • Madrid, Spain
        • Hospital Universitario La Paz
      • Madrid, Spain
        • Hospital Infantil Universitario Nino Jesus
      • Santiago de Compostela, Spain
        • Hospital Clinico Universitario de Santiago de Compostela
      • Sevilla, Spain
        • Hospital Universitario Nuestra Señora de Valme
      • Zaragoza, Spain
        • Hospital Miguel Servet

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

No older than 18 years (Child, Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Healthy paediatric Spanish population

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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)
At the time of participant's single study visit (day 1)

Secondary Outcome Measures

Outcome Measure
Time Frame
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)
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)
At the time of participant's single study visit (day 1)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ipsen

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2012

Primary Completion (Actual)

October 1, 2013

Study Completion (Actual)

October 1, 2013

Study Registration Dates

First Submitted

August 22, 2012

First Submitted That Met QC Criteria

August 29, 2012

First Posted (Estimate)

August 30, 2012

Study Record Updates

Last Update Posted (Actual)

January 11, 2019

Last Update Submitted That Met QC Criteria

January 10, 2019

Last Verified

January 1, 2019

More Information

Terms related to this study

Other Study ID Numbers

  • A-92-52800-020

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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