Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 11:39 PM
Ignite Modification Date:
2025-12-24 @ 11:39 PM
NCT ID:
NCT02400151
Eligibility Criteria:
General Inclusion Criteria:
* The patient's legal representatives must have given their informed and signed consent
* The patient must be insured or beneficiary of a health insurance plan
* Sexual maturation of at least Tanner stage 2
Inclusion criteria for the patient population
* The subject has a body mass index corresponding to grade 2 obesity according to the curves described by Rolland-Cachera et al (1991)
* Absence of at least 5% of total weight over the last 3 months
Inclusion criteria for the control population
* The subject has a body mass index \< 90th percentile
Exclusion Criteria:
* The patient is participating in another study
* The patient is in an exclusion period determined by a previous study
* The patient is under judicial protection
* The patient's legal representative(s) refuse(s) to sign the consent
* It is impossible to correctly inform the patient or his/her legal representative(s)
* The patient has a contraindication for physical activity (joint, heart or other)
* The subject does at least 3 hours of extracurricular physical activity per week
* The subject has a concomitant illness, a history of first-degree cardiovascular disease, abnormal glucose tolerance (pre-diabetes or diabetes).
* Active smoking
* Known dyslipidemia (particularly hypercholesterolemia).
* The subject regularly takes food and vitamin supplements and refuses to stop taking these during the study (in case of disruption of these supplements, a wash-out stopping period of 3 weeks is required).
* BMI corresponding to a grade 1 obesity according to the Rolland-Cachera et al. (1991) curves.
* Secondary or known genetic obesity.
* Known hypersensitivity to vitamin D.
* Hypercalcemia, hypercalciuria, calcium lithiasis
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
11 Years
Maximum Age:
17 Years
Study:
NCT02400151
Study Brief:
Protocol Section:
NCT02400151