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Vitamin D Metabolism in Chronic Kidney Disease Patients

The recruitment status of this study is unknown because the information has not been verified recently.
Verified February 2012 by Memphis VA Medical Center.
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by (Responsible Party):
HALA M ALSHAYEB, Memphis VA Medical Center
ClinicalTrials.gov Identifier:
NCT01528176
First received: February 3, 2012
Last updated: February 13, 2012
Last verified: February 2012

February 3, 2012
February 13, 2012
November 2010
December 2012   (final data collection date for primary outcome measure)
Vitamin D Metabolism in CKD and ESRD Patients with Vitamin D Deficiency treated with Cholicalciferol [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
Measuring 25(OH)D, FGF23, 24,25(OH)₂D, and 1,25(OH)₂D , PTH, Calcium, Phosphorus at baseline and after 8 weeks of cholecalciferol in a cohort of patients with CKD and non CKD who were having vitamin D defeciency treated with cholecalciferol for 8 weeks
  • Vitamin D Matabolism in CKD and ESRD Patients with Vitamin D Deficiency [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
    Measuring 25(OH)D, FGF23, 24, 25(OH)₂D, and 1,25(OH)₂D , PTH, Ca+2, Phosphorus at baseline in a cohort of patients with CKD and non CKD who were having vitamin D defeciency
  • Vitamin D resistance and metabolism in CKD and ESRD treated with Cholicalciferol [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
    To determine whether or not chronic kidney disease (CKD), stages III—V and ESRD , is associated with resistance to elevations of (25(OH)D) after cholecalciferol supplementation.
Complete list of historical versions of study NCT01528176 on ClinicalTrials.gov Archive Site
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Vitamin D Metabolism in Chronic Kidney Disease Patients
Vitamin D Metabolism in Chronic Kidney Disease Patients With Vitamin D Deficiency Treated With Cholecalciferol

To determine whether or not chronic kidney disease (CKD), stages III—V and ESRD , is associated with altered vitamin D metabolism related to fibroblast growth factor-23 (FGF-23) stimulation of Cyp24 and whether they have resistance to elevations of 25 Hydroxyvitamin D (25(OH)D3) after cholecalciferol supplementation.

To determine if such resistance is related to enhanced catabolism of (25(OH)related to elevated levels of FGF-23.

  1. Patients in the Memphis VA Medical Center with documented vitamin D deficiency, determined by measurements of 25(OH)D3, were recruited for this study. 25(OH)D3 measurements are commonly obtained during routine clinical care in both primary care and nephrology clinics. Patient with a wide range of kidney function, ranging from normal estimated glomerular filtration rate (e GFR) to patients with stage III and V (CKD) (estimated GFR <60 ml/min) were recruited treated with weekly oral administration of 10,000 IU of cholecalciferol for a total of 8 weeks in order to correct the vitamin D deficiency.
  2. Data collected:

    Baseline characteristics including demographics, laboratory data obtained at primary care clinic visits, clinical data from the VAMC medical record and medications were obtained at the time of inclusion into the study. Serum concentrations of FGF23, 25(OH)D, 1,25 dihydroxyvitamin D(1,25 (OH)₂D), 24,25 dihydroxyvitamin D(24,25(OH)₂D) ,intact parathyroid hormone (PTH), Calcium, Phosphorous and creatinine and urinary concentrations of calcium, phosphate and creatinine from 24 hr urine collections were obtained at the time of inclusion into the study and after 8 weeks of weekly cholecalciferol therapy. Serum and buffy coats which were recollected from dialysis patient's who agreed to participate, were used to measure mRNA levels of FGF-23, CPY27B1 and Cyp 24 expression.

  3. Methods utilized in analyzing and interpreting the data Descriptive statistics will be performed to compare serum and urinary measurements before and after cholecalciferol therapy. Associations between estimated glomerular filtration rate and levels of vitamin D metabolites and FGF23, before and after treatment, will also be evaluated. The mRNA expression of FGF-23, CPY27B1 and Cyp 24 will be measured in a subset of dialysis patients who completed the treatment course and agreed to provide the additional samples.
  4. Duration of the project: 1 year.
Interventional
Not Provided
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Vitamin D Metabolism is in Chronic Kidney Disease
Drug: 10,000 IU of cholecalciferol for a total of 8 weeks
Subjects were treated with weekly oral administration of 10,000 IU of cholecalciferol for a total of 8 weeks in order to correct the vitamin D deficiency.
(CKD) stages III—V and non -CKD patients
We recruited patients with wide range of eGFR
Intervention: Drug: 10,000 IU of cholecalciferol for a total of 8 weeks
Alshayeb H, Showkat A, Wall BM, Gyamlani GG, David V, Quarles LD. Activation of FGF-23 mediated vitamin D degradative pathways by cholecalciferol. J Clin Endocrinol Metab. 2014 Oct;99(10):E1830-7. doi: 10.1210/jc.2014-1308. Epub 2014 Jun 24.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
70
December 2012
December 2012   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • age 18-85 years; CKD stage III or V; serum 25(OH)D level ≤ 30ng/ml, and serum PTH levels > 70 pg/ml within the last 6 months, informed Consent.

Exclusion Criteria:

  • A history of liver disease, sarcoidosis, intestinal malabsorption;
  • requirement of dialysis during the study; serum calcium level >10.5 mg/dl,
  • calcium-phosphorus product > 70, or
  • calcimimetics, or
  • phosphorus binders; or
  • medications that could affect vitamin D metabolism or
  • history of parathyroidectomy.
Male
18 Years to 85 Years
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01528176
00703, Department of Vetrans Affair
Yes
HALA M ALSHAYEB, Memphis VA Medical Center
Memphis VA Medical Center
Not Provided
Principal Investigator: Barry M Wall, MD Memphis , TN ,VAMC
Principal Investigator: HALA M Alshayeb, MD UTHSC, UCH
Memphis VA Medical Center
February 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP