Status:
COMPLETED
Prevention of Secondary Hyperparathyroidism With Vitamin D in Stage II/III Chronic Kidney Disease
Lead Sponsor:
Atlanta VA Medical Center
Collaborating Sponsors:
Emory University
Conditions:
Kidney Disease
Eligibility:
All Genders
18-85 years
Phase:
NA
Brief Summary
This study will evaluate whether earlier intervention with vitamin D in stage II/III chronic kidney disease will prevent or delay secondary hyperparathyroidism. Subjects will receive vitamin D or plac...
Detailed Description
Vitamin D is important to maintain normal calcium homeostasis and optimal bone health (1, 2). The synthesis of vitamin D and its metabolism to 1,25(OH)2D is regulated by parathyroid hormone (PTH), ser...
Eligibility Criteria
Inclusion
- Study subjects must be patients with CKD stage II/III (estimated glomerular filtration rate, 30-90 ml/min/1.73m body surface area), 25-hydroxyvitamin D (25(OH) D) level \>10 ng/ml documented in the medical record for the past 6 months.
- Estimated Glomerular Filtration Rate will be calculated by using the original Modification of Diet in Renal Disease Study equation (online at http://www.nkdep.nih.gov)(16)
- Study subjects must agree to participate in the study and provide written informed consent
- Histology: not applicable
- Sites: Atlanta VA Medical Center
- Stage of Disease: CKD stage II/III, who has 25-hydroxyvitamin D (25(OH)D) level \>10 ng/ml, but less than 30 ng/ml
- Age: Study subjects must be \>18 but \<85 years old
- Performance Status: Study subjects will be patients with CKD stage II/III (estimated glomerular filtration rate, 30-90 ml/min/1.73m body surface area), 25-hydroxyvitamin D (25(OH)D) level \>10 ng/ml, but less than 30 ng/ml
- Informed consent requirements: All study subjects must agree to participate in the study and provide written informed consent, which will be written in English.
Exclusion
- Age \< 18years or \>85 years old
- Prior other diseases: History of liver failure (AST or ALT \>3 ULN), history of intestinal malabsorption or chronic diarrhea, corrected serum calcium \>10.5 mg/dl, calcium x phosphorus product \>70,treatment with more than 1000 IU of vitamin D per day; or current treatment with a vitamin D analogue or calcimimitec, taking antiepileptic medication, or other medications that could alter vitamin D metabolism(eg, phenytoin, phenobarbital, rifampin(17)
- Infection: not applicable
Key Trial Info
Start Date :
October 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2011
Estimated Enrollment :
48 Patients enrolled
Trial Details
Trial ID
NCT00781417
Start Date
October 1 2008
End Date
December 1 2011
Last Update
February 7 2012
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Atlanta VAMC
Atlanta, Georgia, United States, 30300