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Vitamin D Replacement After Kidney Transplant

The recruitment status of this study is unknown because the information has not been verified recently.
Verified September 2008 by University of Nebraska.
Recruitment status was  Not yet recruiting
Sponsor:
Information provided by:
University of Nebraska
ClinicalTrials.gov Identifier:
NCT00748618
First received: September 4, 2008
Last updated: September 5, 2008
Last verified: September 2008
History of Changes
  Purpose

Vitamin D deficiency accelerates vascular risk progression after kidney transplant.


Condition Intervention Phase
Kidney Transplantation
Vitamin D Deficiency
 Dietary Supplement: vitamin D3
 Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Official Title: Vitamin D Replacement After Kidney Transplant

Resource links provided by NLM:

U.S. FDA Resources

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 ] [ Designated as safety issue: Yes ]

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 ] [ Designated as safety issue: No ]

Estimated Enrollment: 144
Study Start Date: October 2008
Estimated Study Completion Date: March 2010
Estimated Primary Completion Date: October 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 1
10,000 I.U. of vitamin D3
 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
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Kidney transplant more than 6 months ago
  • 19 years or older
  • 25-OH vitamin D ≤30 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
  • Taking 10,000 I.U. or more of vitamin D per week
  • Drinking more than 2 alcohol drinks a day or 14 drinks per week
  • History of parathyroid surgery
  • Known granulomatous disease
  • Magnesium < 1.6 mg/dL
  • Taking any seizure medication that affects vitamin D
  • Taking zempler ® and/or Rocaltrol ®
  • History of kidney stones
  • 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00748618

Contacts
Contact: Jillian M Witte, BSN 402-559-8553 jmwitte@unmc.edu
Contact: Terica L Hudson, BS 402-559-5077 thudson@unmc.edu

Locations
United States, Nebraska
University of Nebraska Medical Center Not yet recruiting
Omaha, Nebraska, United States, 68198
Contact: Jillian M Witte, BSN     402-559-8553     jmwitte@unmc.edu    
Contact: Terica L Hudson, BS     402-559-5077     thudson@unmc.edu    
Principal Investigator: Jennifer L Larsen, MD            
Sponsors and Collaborators
University of Nebraska
Investigators
Principal Investigator: Jennifer L Larsen, MD University of Nebraska
  More Information

No publications provided

Responsible Party: Jennifer Larsen, MD/ Int Med- DEM section chief, University of Nebraska Medical Center
ClinicalTrials.gov Identifier: NCT00748618     History of Changes
Other Study ID Numbers: 382-08-FB
Study First Received: September 4, 2008
Last Updated: September 5, 2008
Health Authority: United States: Institutional Review Board

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
Cholecalciferol
Vitamin D
 Ergocalciferols
Vitamins
Micronutrients
Growth Substances
Physiological Effects of Drugs
Pharmacologic Actions
Bone Density Conservation Agents

ClinicalTrials.gov processed this record on June 13, 2013