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:
2025-12-26 @ 11:09 AM
Ignite Modification Date:
2025-12-26 @ 11:09 AM
NCT ID:
NCT06419712
Eligibility Criteria:
Inclusion Criteria:
* Diagnosis of Post-COVID-19 Condition: Patients must have been previously diagnosed with COVID-19 and continue to experience persistent symptoms after recovery.
* Age: Participants must be adults aged 18 years or older.
* Vitamin D Deficiency: Initial serum 25-hydroxyvitamin D levels below 40 ng/mL.
* Completed Hospital Treatment for COVID-19: Patients must have been discharged from hospital treatment for COVID-19 at least 12 months prior to the study.
* Ability to Give Informed Consent: Participants must be capable of understanding and willing to sign a consent form.
* Ability to Perform Required Tests: Participants must be physically able to undergo spirometry and other functional tests as required by the study protocol.
Exclusion Criteria:
* Reading and Writing Difficulties: Patients who have difficulties in reading and/or writing that would impede their understanding of the study requirements or communication with study staff.
* Inability to Perform Physical Tests: Patients unable to perform functional walk and spirometry tests.
* Untreated Chronic Non-Respiratory Diseases: Individuals suffering from untreated chronic diseases such as diabetes mellitus, systemic arterial hypertension, hypothyroidism, or epilepsy that could interfere with the study outcomes.
* Recent Use of Vitamin D Supplements: Patients who have taken vitamin D supplements within three months prior to the start of the study.
* Participation in Other Clinical Trials: Patients currently participating in other clinical trials that might conflict with this study's protocol.
* Pregnancy: Due to potential risks and lack of data on high-dose vitamin D supplementation during pregnancy, pregnant women will be excluded.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
70 Years
Study:
NCT06419712
Study Brief:
Protocol Section:
NCT06419712