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

• ClinicalTrials.gov Identifier: NCT00752401
• Recruitment Status: Unknown
• First Posted: September 15, 2008
• Last Update Posted: January 22, 2014
• Sponsor: Medical University of Vienna
• Information provided by (Responsible Party): Kyra Borchhardt, Medical University of Vienna

Study Description

Brief Summary:

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 or disease	Intervention/treatment	Phase
Kidney Transplantation; Vitamin D Deficiency; Renal Osteodystrophy	Drug: Cholecalciferol; Drug: Placebo	Phase 3

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.

Study Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 200 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Quadruple (Participant, Care Provider, 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
• Study Start Date: May 2009
• Estimated Primary Completion Date: July 2014
• Estimated Study Completion Date: July 2014

Arms and Interventions

Arm	Intervention/treatment
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.

Outcome Measures

Primary Outcome Measures :

1. 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 ]
2. Number of acute rejection episodes [ Time Frame: one year after kidney transplantation ]
3. Number of infections [ Time Frame: one year after kidney transplantation ]
4. CRP levels [ Time Frame: one year after kidney transplantation ]
5. Courses of calcium levels [ Time Frame: within the first year after kidney transplantation ]

Secondary Outcome Measures :

1. 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 ]

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 85 Years (Adult, Older Adult)
• Sexes Eligible for Study: All
• 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

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

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Thiem U, Heinze G, Segel R, Perkmann T, Kainberger F, Mühlbacher F, Hörl W, Borchhardt K. VITA-D: cholecalciferol substitution in vitamin D deficient kidney transplant recipients: a randomized, placebo-controlled study to evaluate the post-transplant outcome. Trials. 2009 May 29;10:36. doi: 10.1186/1745-6215-10-36.

• 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
• First Posted: September 15, 2008
• Last Update Posted: January 22, 2014
• Last Verified: January 2014

Keywords provided by Kyra Borchhardt, 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:

Chronic Kidney Disease-Mineral and Bone Disorder; Vitamin D Deficiency; Avitaminosis; Deficiency Diseases; Malnutrition; Nutrition Disorders; Rickets; Bone Diseases, Metabolic; Bone Diseases; Musculoskeletal Diseases; Kidney Diseases; Urologic Diseases; Metabolic Diseases; Calcium Metabolism Disorders; Hyperparathyroidism, Secondary; Hyperparathyroidism; Parathyroid Diseases; Endocrine System Diseases; Vitamin D; Ergocalciferols; Cholecalciferol; Vitamins; Micronutrients; Nutrients; Growth Substances; Physiological Effects of Drugs; Bone Density Conservation Agents; Calcium-Regulating Hormones and Agents