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 @ 11:20 PM
Ignite Modification Date:
2025-12-24 @ 11:20 PM
NCT ID:
NCT01214356
Eligibility Criteria:
Inclusion Criteria:
* African American race
* Diagnosis of Type 2 Diabetes
* Stage 1 or 2 Kidney Disease with detectable microalbuminuria \>4.0 (mg/g) 25(OH)D level \<20 ng/ml
Exclusion Criteria:
* Type 1 diabetes
--\> Stage 3 Kidney Disease, or history of dialysis, kidney transplantation or nephrolithiasis
* Unable to provide informed consent or contact information
* Pre-existing calcium or parathyroid condition, including serum calcium \>10.2 mg/dL
* Sarcoidosis, active tuberculosis, or malignancy
* Known hypersensitivity to vitamin D or any of its analogues and derivatives
* Current pregnancy or planning to become pregnant in next 15 months
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT01214356
Study Brief:
Protocol Section:
NCT01214356