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 @ 2:31 PM
Ignite Modification Date:
2025-12-24 @ 2:31 PM
NCT ID:
NCT05706259
Eligibility Criteria:
Inclusion Criteria:
* Healthy male and female adults aged 18 - 60 years
* Vitamin D deficiency as shown by serum levels of 25 (OH) D3 levels of \< 20 ng/mL
* Able to provide informed written consent
Exclusion Criteria:
* Clinically significant abnormal laboratory parameters (such as complete blood count, CRP, d-dimer, liver enzymes, creatinine) indicative of physical illness, especially hypercalcemia and hypercalciuria
* History of hypersensitivity to vitamin D3 supplements
* History of renal, hepatic, gastrointestinal, cardiovascular, respiratory, skin, haematological, endocrine, or neurological diseases
* Prior use of medications in general containing calcium, magnesium, or vitamin D3, four weeks before the start of the study
* Participation in the evaluation of any investigational product or blood donations in the last three months before this study
* Any other significant disease or disorder that, in the opinion of the Physician, may either put the participant at risk because of participation in the study, or may influence the results of the study, or the participant's ability to participate in the study
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT05706259
Study Brief:
Protocol Section:
NCT05706259