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 @ 7:46 PM
Ignite Modification Date:
2025-12-24 @ 7:46 PM
NCT ID:
NCT01018303
Eligibility Criteria:
Inclusion Criteria:
* Diagnosis of CF as evidenced by a sweat chloride test \> 60mEq/L or by the presence of two known CF mutations
* Male or female, ages between 10-40 years old
* \> 30 kg body weight
* FEV1 \> 35% predicted for age and height
* Clinically stable with no recent hospitalization within the past 2 weeks
Exclusion Criteria:
* Significant liver disease as defined by clinical findings of portal hypertension or cirrhosis or AST, ALT, or GGT \>2x upper limits of normal within the previous 6 months
* Poor compliance with medical regimen as assessed by CF clinic care providers
* Oral supplementation with AquADEKs or another source of beta-carotene or CoQ10 in the 2 months prior to the study
* Pregnant or lactating
* Participation in another interventional clinical trial within the previous 2 weeks
* Difficulty swallowing softgels
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
10 Years
Maximum Age:
40 Years
Study:
NCT01018303
Study Brief:
Protocol Section:
NCT01018303