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Vitamin D Replacement After Kidney Transplant

This study is ongoing, but not recruiting participants.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00748618
First Posted: September 8, 2008
Last Update Posted: May 15, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Jennifer Larsen, MD, University of Nebraska
  Purpose
Vitamin D deficiency accelerates vascular risk progression after kidney transplant.

Condition Intervention
Kidney Transplantation Vitamin D Deficiency Dietary Supplement: vitamin D3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Vitamin D Replacement After Kidney Transplant

Resource links provided by NLM:


Further study details as provided by Jennifer Larsen, MD, University of Nebraska:

Primary Outcome Measures:
  • Compare efficacy and safety of two vitamin D supplements of these doses in normalizing vitamin D concentrations. [ Time Frame: 6 months ]

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. [ Time Frame: 6 months ]

Enrollment: 165
Study Start Date: October 2008
Estimated Study Completion Date: December 2017
Primary Completion Date: April 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
1
Standard vitamin treatment
Dietary Supplement: vitamin D3
10,000 I.U./wk of vitamin D3 orally for 6 months
Other Name: D3, vitamin D
Active Comparator: 2
50,000 I.U. of vitamin D3
Dietary Supplement: vitamin D3
50,000 I.U./wk of vitamin D3 orally for 6 months
Other Name: D3, vitamin D

Detailed Description:

This trial will assess the following aims:

  1. Time to plateau vitamin D concentrations after initiating vitamin D supplements
  2. Safety of vitamin D replacement based on serum and urine calcium
  3. Effect of vitamin D on PTH concentration in individuals with elevated parathyroid hormone
  4. Effect of vitamin D on markers of insulin resistance and inflammation
  Eligibility

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Ages Eligible for Study:   19 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00748618


Locations
United States, Nebraska
University of Nebraska Medical Center
Omaha, Nebraska, United States, 68198
Sponsors and Collaborators
University of Nebraska
Investigators
Principal Investigator: Jennifer L Larsen, MD University of Nebraska
  More Information

Responsible Party: Jennifer Larsen, MD, Vice Chancelor of Research, University of Nebraska
ClinicalTrials.gov Identifier: NCT00748618     History of Changes
Other Study ID Numbers: 382-08-FB
First Submitted: September 4, 2008
First Posted: September 8, 2008
Last Update Posted: May 15, 2017
Last Verified: May 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Keywords provided by Jennifer Larsen, MD, University of Nebraska:
Kidney transplantation (KTX)
Vitamin D deficiency
Cardiovascular Disease (CVD)
Vascular risk
Parathyroid hormone (PTH)
Carotid intima media thickness (CIMT)
Insulin resistance (IR)

Additional relevant MeSH terms:
Vitamin D Deficiency
Avitaminosis
Deficiency Diseases
Malnutrition
Nutrition Disorders
Vitamins
Vitamin D
Ergocalciferols
Cholecalciferol
Micronutrients
Growth Substances
Physiological Effects of Drugs
Bone Density Conservation Agents