Vitamin D3 Substitution in Vitamin D Deficient Kidney Transplant Recipients (VITA-D)

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Kyra Borchhardt, Medical University of Vienna
ClinicalTrials.gov Identifier:
NCT00752401
First received: September 11, 2008
Last updated: January 20, 2014
Last verified: January 2014
  Purpose

The purpose of the study is to evaluate the effects of Cholecalciferol (Vitamin D3) substitution on the posttransplant outcome (glomerular filtration rate as well as serum creatinine levels, number of acute rejection episodes, number of infections and C-reactive protein levels within the first year after transplantation) in vitamin D deficient kidney transplant recipients.


Condition Intervention Phase
Kidney Transplantation
Vitamin D Deficiency
Renal Osteodystrophy
Drug: Cholecalciferol
Drug: Placebo
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: VITA-D: Cholecalciferol Substitution in Vitamin D Deficient Kidney Transplant Recipients: A Randomized, Placebo-controlled Study to Evaluate the Posttransplant Outcome

Resource links provided by NLM:


Further study details as provided by Medical University of Vienna:

Primary Outcome Measures:
  • The immunologic effects of Vitamin D3 substitution in vitamin D deficient kidney transplant recipients will be evaluated by means of: Glomerular filtration rate [ Time Frame: one year after kidney transplantation ] [ Designated as safety issue: No ]
  • Number of acute rejection episodes [ Time Frame: one year after kidney transplantation ] [ Designated as safety issue: No ]
  • Number of infections [ Time Frame: one year after kidney transplantation ] [ Designated as safety issue: No ]
  • CRP levels [ Time Frame: one year after kidney transplantation ] [ Designated as safety issue: No ]
  • Courses of calcium levels [ Time Frame: within the first year after kidney transplantation ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • The impact of Vitamin D3 substitution on renal osteopathy will be analyzed by means of absolute bone mineral density (g/cm2) [ Time Frame: within the first year after kidney transplantation ] [ Designated as safety issue: No ]

Estimated Enrollment: 200
Study Start Date: May 2009
Estimated Study Completion Date: July 2014
Estimated Primary Completion Date: July 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 1
6800 IU/day of Cholecalciferol (Vitamin D3) orally for one year
Drug: Cholecalciferol
6800 IU of Cholecalciferol will be administered in the form of Oleovit® D3-drops once a day for one year. Treatment starts on day 5 after kidney transplantation. At serum calcium levels >2,65 mmol/l vitamin D3 administration will be reduced to 3600 IU per day. If calcium levels persist above 2,85 mmol/l over a period of four weeks vitamin D3 administration will be discontinued and restarted when serum calcium levels declined to ≤ 2,65 mmol/l with only 3600 International Units per day.
Other Names:
  • Vitamin D3
  • Oleovit® D3
Placebo Comparator: 2
Oral placebo solution daily for one year
Drug: Placebo
An oral placebo solution matching Cholecalciferol in terms of appearance, smell and taste will be administered once a day for one year. Treatment starts on day 5 after kidney transplantation.

Detailed Description:

Apart from its classical actions in calcium homeostasis, vitamin D acts as a potent immunomodulatory agent. As such, vitamin D is thought to have beneficial effects in the transplant setting, especially in kidney transplant recipients considering the fact that approximately 40% of all kidney transplant recipients are vitamin D deficient.

Therefore, the objective is to conduct a randomized, double-blind, placebo-controlled study focusing on the impact of Cholecalciferol substitution in vitamin D deficient kidney transplant recipients on graft function (glomerular filtration rate as well as serum creatinine levels), incidence of acute rejection episodes, frequency and severity (CRP levels) of posttransplant infections within the first year after kidney transplantation.

Moreover, the impact of Vitamin D3 on renal osteodystrophy will be analyzed by means of bone mineral density. DXA measurements will be performed during the first four weeks after kidney transplantation, after 5, and after 12 months posttransplant.

Kidney transplant recipients found to have vitamin D deficiency (defined as 25-hydroxyvitamin D < 50 nmol/l) will be included and will be randomized to receive either oral Vitamin D3 therapy or placebo. Vitamin D3 will be administered at a daily dose of 6800IU over a time period of one year.

All in all, 200 subjects will be included in the VITA-D study.

  Eligibility

Ages Eligible for Study:   18 Years to 85 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • age > 18
  • deceased donor kidney transplant recipients
  • only kidney transplant recipients
  • vitamin D deficiency defined as 25 (OH)D < 50nmol/l

Exclusion Criteria:

  • re-transplantation for the second time if the patient is highly immunized and therefore included in the aphaeresis program
  • re-transplantation for the third or further time
  • significant impaired intestinal resorption: malabsorption due to celiac sprue, systemic scleroderma; maldigestion due to chronic pancreatitis, pancreatic insufficiency, pancreas resection, mucoviscidosis, Zollinger-Ellison-syndrome
  • history of inflammatory bowel disease: Crohn's disease, ulcerative colitis
  • previous gastrectomy, small bowel or large bowel resection, intestinal bypass surgery
  • severe liver disease: cirrhosis
  • HIV positive
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00752401

Locations
Austria
Medical University of Vienna, Department of Internal Medicine III, Division of Nephrology and Dialysis
Vienna, Austria
Sponsors and Collaborators
Medical University of Vienna
Investigators
Principal Investigator: Kyra Borchhardt, MD Medical University of Vienna, Department of Internal Medicine III, Division of Nephrology and Dialysis
  More Information

No publications provided by Medical University of Vienna

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Kyra Borchhardt, Priv.-Doz. Dr., Medical University of Vienna
ClinicalTrials.gov Identifier: NCT00752401     History of Changes
Other Study ID Numbers: VitaD-1, EudraCT Number 2008-002807-21
Study First Received: September 11, 2008
Last Updated: January 20, 2014
Health Authority: Austria: Federal Office for Safety in Health Care

Keywords provided by Medical University of Vienna:
Vitamin D
Cholecalciferol
Vitamin D3
25-hydroxyvitamin D3
Immunomodulation
Vitamin D deficiency
Kidney transplantation
Renal transplantation
Graft function
Acute rejection
Renal osteodystrophy
Posttransplant bone loss

Additional relevant MeSH terms:
Vitamin D Deficiency
Renal Osteodystrophy
Avitaminosis
Deficiency Diseases
Malnutrition
Nutrition Disorders
Bone Diseases, Metabolic
Bone Diseases
Musculoskeletal Diseases
Rickets
Kidney Diseases
Urologic Diseases
Calcium Metabolism Disorders
Metabolic Diseases
Hyperparathyroidism, Secondary
Hyperparathyroidism
Parathyroid Diseases
Endocrine System Diseases
Vitamins
Vitamin D
Ergocalciferols
Cholecalciferol
Micronutrients
Growth Substances
Physiological Effects of Drugs
Pharmacologic Actions
Bone Density Conservation Agents

ClinicalTrials.gov processed this record on September 16, 2014