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
  Purpose

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.


Condition Intervention
Vitamin D Metabolism is in Chronic Kidney Disease
Drug: 10,000 IU of cholecalciferol for a total of 8 weeks

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Official Title: Vitamin D Metabolism in Chronic Kidney Disease Patients With Vitamin D Deficiency Treated With Cholecalciferol

Resource links provided by NLM:


Further study details as provided by Memphis VA Medical Center:

Primary Outcome Measures:
  • 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


Enrollment: 70
Study Start Date: November 2010
Estimated Study Completion Date: December 2012
Estimated Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
(CKD) stages III—V and non -CKD patients
We recruited patients with wide range of eGFR
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.

Detailed 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.
  Eligibility

Ages Eligible for Study:   18 Years to 85 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01528176

Locations
United States, Tennessee
Memphis Veteran Affair Medical center
Memphis, Tennessee, United States, 38194
Sponsors and Collaborators
Memphis VA Medical Center
Investigators
Principal Investigator: Barry M Wall, MD Memphis , TN ,VAMC
Principal Investigator: HALA M Alshayeb, MD UTHSC, UCH
  More Information

No publications provided

Responsible Party: HALA M ALSHAYEB, Principal Investigator, Memphis VA Medical Center
ClinicalTrials.gov Identifier: NCT01528176     History of Changes
Other Study ID Numbers: 00703, Department of Vetrans Affair
Study First Received: February 3, 2012
Last Updated: February 13, 2012
Health Authority: United States: Food and Drug Administration
United States: Federal Government

Keywords provided by Memphis VA Medical Center:
FGF-23, CKD, Cyp24, 24,25(OH)2D, vitamin D metabolism

Additional relevant MeSH terms:
Kidney Diseases
Vitamin D Deficiency
Renal Insufficiency, Chronic
Urologic Diseases
Avitaminosis
Deficiency Diseases
Malnutrition
Nutrition Disorders
Renal Insufficiency
Cholecalciferol
Vitamin D
Ergocalciferols
Vitamins
Micronutrients
Growth Substances
Physiological Effects of Drugs
Pharmacologic Actions
Bone Density Conservation Agents

ClinicalTrials.gov processed this record on August 20, 2014