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:
2025-12-25 @ 12:40 AM
Ignite Modification Date:
2025-12-25 @ 12:40 AM
NCT ID:
NCT04987567
Eligibility Criteria:
Inclusion Criteria:
* Patients of both genders with a diagnosis of cystic fibrosis.
* FEV1 \> 40%.
* Age between 6 and 18 years.
* Patients who grant their informed consent or whose representative grants informed consent to participate in the study.
Exclusion Criteria:
* Pregnant or breastfeeding women
* Basal oxygen saturation \<92% or household supplemental oxygen needs.
* Massive hemoptysis
* Patients who are not able to follow or who cannot be assessed in the study according to the protocol.
* Any circumstance that, at the discretion of the doctor, may involve a clinical risk or harm, the patient's participation in the study or that interferes with the evaluation of the same.
* Use of systemic glucocorticoids or in the 4 weeks prior to inclusion in the study.
* Use of non-steroidal anti-inflammatory drugs in the 2 weeks prior to inclusion in the study.
* Use of investigational drugs or participation in another clinical trial within 30 days prior to inclusion in the study or within the 5 elimination half-lives of the investigational drug.
* Be already supplementing with Omega -3, fish oil or DHA
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
6 Years
Maximum Age:
18 Years
Study:
NCT04987567
Study Brief:
Protocol Section:
NCT04987567