Vitamin D Metabolism in Chronic Kidney Disease Patients

Vitamin D Metabolism is in Chronic Kidney Disease Clinical Trial

Official title:

Vitamin D Metabolism in Chronic Kidney Disease Patients With Vitamin D Deficiency Treated With Cholecalciferol

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01528176
• Other study ID #: 00703
• Secondary ID: Department of Ve
• Status: Active, not recruiting
• Phase: N/A
• First received: February 3, 2012
• Last updated: February 13, 2012
• Start date: November 2010
• Est. completion date: December 2012

Study information

• Verified date: February 2012
• Source: Memphis VA Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug AdministrationUnited States: Federal Government
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 70
• Est. completion date: December 2012
• Est. primary completion date: December 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 85 Years

Eligibility

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.

Study Design

Allocation: Non-Randomized, Intervention Model: Single Group Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Kidney Diseases
• Renal Insufficiency, Chronic
• Vitamin D Metabolism is in Chronic Kidney Disease

Intervention

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.

Locations

Country	Name	City	State
United States	Memphis Veteran Affair Medical center	Memphis	Tennessee

Sponsors (1)

Lead Sponsor	Collaborator
Memphis VA Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Vitamin D Metabolism in CKD and ESRD Patients with Vitamin D Deficiency treated with Cholicalciferol	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	8 weeks	No