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 @ 9:42 PM
Ignite Modification Date:
2025-12-24 @ 9:42 PM
NCT ID:
NCT00438932
Eligibility Criteria:
Inclusion Criteria:
* subjects with stage 3a, 3b and 4 CKD
* subjects have to be aged 18 years or older
* subjects have to have normal serum phosphate levels (\< 4.6 mg/dl)
* subjects have to have sufficient 25-OH Vit0amin D levels (≥ 20 ng/ml)
Exclusion Criteria:
* subjects with rapidly advancing renal failure who thus might develop hyperphosphatemia or end stage renal disease requiring initiation of dialysis during the study period
* subjects expected to require dialysis initiation within the follow up period
* subjects with hyperphosphatemia \> 4.6 mg/dL
* subjects with any previous or current treatment with phosphate binders or active vitamin D (doxercalciferol or calcitriol)
* subjects with malnutrition, defined as a serum albumin \< 3.0 mg/dl, in order to avoid worsening protein-malnutrition status during the restricted study period since phosphate restricted diets are also low in protein
* subjects with chronic gastrointestinal diseases that could impede their absorptive ability such as Crohn's disease, ulcerative colitis and sprue
* subjects with liver disease (ALT or AST \> 100 U/L) or cholestasis (direct bilirubin \> 1.0 mg/dl) because this can limit their ability to absorb fat soluble vitamins such as vitamin D
* subjects with anemia, defined as a hematocrit \<27% at the screening visit
* subjects wht have been hospitalization within the previous 4 weeks
* subjects who are pregnant
* subjects who are breastfeeding mothers
* subjects with primary hypoparathyroidism
* subjects with primary hyperparathyroidism
* subjects with previous subtotal parathyroidectomy
* subjects with previous outpatient counseling by a renal nutritionist
* subjects who are unable to independently provide written informed consent - prisoners, mentally incompetent, minors
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
80 Years
Study:
NCT00438932
Study Brief:
Protocol Section:
NCT00438932