Status:
COMPLETED
Low Phosphate Diets in Patients With Early Stages of Chronic Kidney Disease
Lead Sponsor:
Massachusetts General Hospital
Collaborating Sponsors:
Shire
Conditions:
Chronic Kidney Disease
Eligibility:
All Genders
18-80 years
Phase:
NA
Brief Summary
The purpose of this study is to learn more about how the kidneys control the blood levels of phosphorus in patients with early chronic kidney disease. The ultimate goal is to use this information to d...
Detailed Description
Phosphorus is a mineral found in dairy products, nuts, and meat that is essential for bone health and many other important functions inside the body's cells. The kidneys are responsible for keeping th...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
January 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2010
Estimated Enrollment :
16 Patients enrolled
Trial Details
Trial ID
NCT00438932
Start Date
January 1 2007
End Date
January 1 2010
Last Update
September 27 2011
Active Locations (1)
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1
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114