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 @ 11:09 PM
Ignite Modification Date:
2025-12-24 @ 11:09 PM
NCT ID:
NCT03073369
Eligibility Criteria:
Inclusion Criteria:
* Participants 19 years or older with mild to moderate CKD (eGFR 15 - 59 ml/min/1.73 m2) by the CKD-EPI formula, with vitamin D deficiency (25(OH)D \< 30 ng/ml), and with absolute iron deficiency (TSAT \< 20 and Ferritin \<100) or iron restriction (TSAT \< 20 and Ferritin \> 100).
Exclusion Criteria:
* Active vitamin D analog therapy or history of recent (\< 3 months) use.
* Nutritional vitamin D (cholecalciferol or ergocalciferol) therapy in dosages greater than 2000 IU/day.
* Subjects receiving erythropoiesis stimulating agents or intravenous iron therapy.
* Oral iron therapy started within the last 3 months.
* Hb \< 8.0 g/dL for males and Hb \<7.0 g/dL for females.
* Pregnancy or lactation.
* Serum calcium \> 10.0 mg/dL or phosphorus \> 4.5 mg/dL.
* Subjects with acute kidney injury or rapidly declining GFR.
* Subjects on hemodialysis, peritoneal dialysis, or having a functioning renal transplant.
* Focus of active inflammation such as acute gout, rheumatoid arthritis or active infection determined clinically.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
19 Years
Study:
NCT03073369
Study Brief:
Protocol Section:
NCT03073369