CClinicalTrials.gg
Status unknownNCT01528176Updated Feb 14, 2012

Vitamin D Metabolism in Chronic Kidney Disease Patients

An interventional study of 10,000 IU of cholecalciferol for a total of 8 weeks in Vitamin D Metabolism is in Chronic Kidney Disease, sponsored by Memphis VA Medical Center. Status unknown at 1 site in United States. Open to male participants aged 18 Years to 85 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2012-02-14.

Sponsored by Memphis VA Medical Center · Not applicable and Interventional

The sponsor has not verified this record recently (last verified Feb 2012), so the status shown — last known as Active, not recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
70
Allocation
Non-randomized
Ages
18 Years to 85 Years
Sex
Male
01

Study 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.

Read the 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.
02

Conditions studied

  • Vitamin D Metabolism is in Chronic Kidney Disease

Keywords

  • FGF-23, CKD, Cyp24, 24,25(OH)2D, vitamin D metabolism
03

Who can participate

Ages eligible
18 Years to 85 Years
Sexes eligible
Male
Accepts healthy volunteers
Yes

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

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.
04

Study design

Phase
Not applicable
Allocation
Non-randomized
Intervention model
Single group
Masking
None (open label)
Enrollment
70 participants (actual)

Study arms

  • Other
    (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

Interventions

  • Drug10,000 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.

05

What researchers measure

Primary outcomes

  1. 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

    Time frame: 8 weeks

06

Study locations

1 site
  • Memphis Veteran Affair Medical center
    Memphis, Tennessee 38194, United States
07

References and documents

Publications

  • 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. PubMed 24960544 ↗
08

Registry details

Key details

Study ID
NCT01528176
Lead sponsor
Memphis VA Medical Center
Responsible party
HALA M ALSHAYEB (Principal Investigator, Memphis VA Medical Center) — Principal investigator
First posted
Feb 7, 2012
Start date
Nov 2010
Primary completion
Dec 2012 (estimated)
Completion
Dec 2012 (estimated)
Last update
Feb 14, 2012

Study contacts

Barry M Wall, MD
principal investigator · Memphis , TN ,VAMC
HALA M Alshayeb, MD
principal investigator · UTHSC, UCH

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

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This study is status unknown, as verified in Feb 2012. You cannot join it, but the record below documents what was studied.

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