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Vitamin D Replacement After Kidney Transplant

Primary Purpose

Kidney Transplantation, Vitamin D Deficiency

Status
Active
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
vitamin D3
vitamin D3
Sponsored by
University of Nebraska
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Kidney Transplantation focused on measuring Kidney transplantation (KTX), Vitamin D deficiency, Cardiovascular Disease (CVD), Vascular risk, Parathyroid hormone (PTH), Carotid intima media thickness (CIMT), Insulin resistance (IR)

Eligibility Criteria

19 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Kidney transplant more than 6 months ago
  • 19 years or older
  • 25-OH vitamin D ≤35 ng/ml

Exclusion Criteria:

  • Estimated GFR<30 ml/min/1.73m²
  • Previous small bowel or lung transplant
  • Pancreas transplant less than 6 months ago
  • Cancer or any condition that would change their weight dramatically in the near future such as malabsorption
  • Willing to return for testing every two months
  • Women who are pregnant or < 6 weeks postpartum
  • Calcium > 10.5 mg/dl
  • Phosphate > 4.8 mg/dl
  • Drinking more than 2 alcohol drinks a day or 14 drinks per week
  • History of parathyroid surgery
  • Known granulomatous disease
  • Taking any seizure medication that affects vitamin D
  • Taking zempler ® and/or Rocaltrol ®
  • History of kidney stones in the past 20 years
  • Not on a stable dose of bisphosphonate for the past three months
  • Planning on a pancreas transplant within the next year
  • In any other research study

Sites / Locations

  • University of Nebraska Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Active Comparator

Arm Label

1

2

Arm Description

Standard vitamin treatment

50,000 I.U. of vitamin D3

Outcomes

Primary Outcome Measures

Compare efficacy and safety of two vitamin D supplements of these doses in normalizing vitamin D concentrations.

Secondary Outcome Measures

The ability of vitamin D to reduce parathyroid hormone concentration or change markers of vascular risk, insulin resistance, and/or inflammation, as well as its affect on urine calcium excretion.

Full Information

First Posted
September 4, 2008
Last Updated
October 20, 2022
Sponsor
University of Nebraska
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1. Study Identification

Unique Protocol Identification Number
NCT00748618
Brief Title
Vitamin D Replacement After Kidney Transplant
Official Title
Vitamin D Replacement After Kidney Transplant
Study Type
Interventional

2. Study Status

Record Verification Date
October 2022
Overall Recruitment Status
Active, not recruiting
Study Start Date
October 2008 (Actual)
Primary Completion Date
April 2012 (Actual)
Study Completion Date
June 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Nebraska

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
Vitamin D deficiency accelerates vascular risk progression after kidney transplant.
Detailed Description
This trial will assess the following aims: Time to plateau vitamin D concentrations after initiating vitamin D supplements Safety of vitamin D replacement based on serum and urine calcium Effect of vitamin D on PTH concentration in individuals with elevated parathyroid hormone Effect of vitamin D on markers of insulin resistance and inflammation

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Kidney Transplantation, Vitamin D Deficiency
Keywords
Kidney transplantation (KTX), Vitamin D deficiency, Cardiovascular Disease (CVD), Vascular risk, Parathyroid hormone (PTH), Carotid intima media thickness (CIMT), Insulin resistance (IR)

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
165 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Other
Arm Description
Standard vitamin treatment
Arm Title
2
Arm Type
Active Comparator
Arm Description
50,000 I.U. of vitamin D3
Intervention Type
Dietary Supplement
Intervention Name(s)
vitamin D3
Other Intervention Name(s)
D3, vitamin D
Intervention Description
10,000 I.U./wk of vitamin D3 orally for 6 months
Intervention Type
Dietary Supplement
Intervention Name(s)
vitamin D3
Other Intervention Name(s)
D3, vitamin D
Intervention Description
50,000 I.U./wk of vitamin D3 orally for 6 months
Primary Outcome Measure Information:
Title
Compare efficacy and safety of two vitamin D supplements of these doses in normalizing vitamin D concentrations.
Time Frame
6 months
Secondary Outcome Measure Information:
Title
The ability of vitamin D to reduce parathyroid hormone concentration or change markers of vascular risk, insulin resistance, and/or inflammation, as well as its affect on urine calcium excretion.
Time Frame
6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
19 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Kidney transplant more than 6 months ago 19 years or older 25-OH vitamin D ≤35 ng/ml Exclusion Criteria: Estimated GFR<30 ml/min/1.73m² Previous small bowel or lung transplant Pancreas transplant less than 6 months ago Cancer or any condition that would change their weight dramatically in the near future such as malabsorption Willing to return for testing every two months Women who are pregnant or < 6 weeks postpartum Calcium > 10.5 mg/dl Phosphate > 4.8 mg/dl Drinking more than 2 alcohol drinks a day or 14 drinks per week History of parathyroid surgery Known granulomatous disease Taking any seizure medication that affects vitamin D Taking zempler ® and/or Rocaltrol ® History of kidney stones in the past 20 years Not on a stable dose of bisphosphonate for the past three months Planning on a pancreas transplant within the next year In any other research study
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jennifer L Larsen, MD
Organizational Affiliation
University of Nebraska
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Nebraska Medical Center
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
68198
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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Vitamin D Replacement After Kidney Transplant

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