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Vitamin D Replacement After Kidney Transplant

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Jennifer Larsen, MD, University of Nebraska
ClinicalTrials.gov Identifier:
NCT00748618
First received: September 4, 2008
Last updated: May 11, 2017
Last verified: May 2017
  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: Participant, Investigator
Primary Purpose: Treatment
Official Title: Vitamin D Replacement After Kidney Transplant

Resource links provided by NLM:


Further study details as provided by 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

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
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Please refer to this study by its ClinicalTrials.gov identifier: 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
Study First Received: September 4, 2008
Last Updated: May 11, 2017
Individual Participant Data  
Plan to Share IPD: Undecided

Keywords provided by 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

ClinicalTrials.gov processed this record on May 22, 2017