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EDISONAn 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

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What is being collected

Data Collection

Collected at a single point in time - Cross-sectional
Who is being recruted

Until 18 Years
+13 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Other

Utilizing specific methods not covered by standard models in order to address unique research questions.
Observational
Study Start: July 2012
See protocol details

Summary

Principal SponsorIpsen
Last updated: January 11, 2019
Sourced from a government-validated database.Claim as a partner

Study start date: July 1, 2012

Actual date on which the first participant was enrolled.

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.

NCT01676090
Principal SponsorIpsen
Last updated: January 11, 2019
Sourced from a government-validated database.Claim as a partner

Protocol

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

304 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Other

Some studies use unique or mixed approaches that don't fit standard categories. These may include innovative observational methods or studies tailored to specific research questions.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Until 18 Years

Range of ages for which participants are eligible to join.

Healthy volunteers allowed

If individuals who are healthy and do not have the condition being studied can participate.

Criteria

4 inclusion criteria required to participate
Age: newborns up to and including 18 years of age
Children of either sex of Caucasian parents
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
9 exclusion criteria prevent from participating
A family history of short stature (either parent < P3)
Adopted children or conceived through in vitro fertilization ( IVF )
An acute disease during the last two weeks prior to recruitment
Any clinically significant out-of-range lab value
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Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Study Objectives

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 9 locations

Fundación Sant Joan de Deu

Barcelona, SpainOpen Fundación Sant Joan de Deu in Google Maps

Hospital Universitari Vall d´Hebron

Barcelona, Spain

Hospital de Cruces

Bilbao, Spain

Hospital 12 de Octubre

Madrid, Spain
Suspended9 Study Centers