Vitamin D3 Substitution in Vitamin D Deficient Kidney Transplant Recipients (VITA-D)
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ClinicalTrials.gov Identifier: NCT00752401 |
Recruitment Status : Unknown
Verified January 2014 by Kyra Borchhardt, Medical University of Vienna.
Recruitment status was: Active, not recruiting
First Posted : September 15, 2008
Last Update Posted : January 22, 2014
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Condition or disease | Intervention/treatment | Phase |
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Kidney Transplantation Vitamin D Deficiency Renal Osteodystrophy | Drug: Cholecalciferol Drug: Placebo | Phase 3 |
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 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 |

Arm | Intervention/treatment |
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Active Comparator: 1
6800 IU/day of Cholecalciferol (Vitamin D3) orally for one year
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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:
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Placebo Comparator: 2
Oral placebo solution daily for one year
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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. |
- 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 ]
- Number of acute rejection episodes [ Time Frame: one year after kidney transplantation ]
- Number of infections [ Time Frame: one year after kidney transplantation ]
- CRP levels [ Time Frame: one year after kidney transplantation ]
- Courses of calcium levels [ Time Frame: within the first year after kidney transplantation ]
- 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 ]

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Ages Eligible for Study: | 18 Years to 85 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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

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): NCT00752401
Austria | |
Medical University of Vienna, Department of Internal Medicine III, Division of Nephrology and Dialysis | |
Vienna, Austria |
Principal Investigator: | Kyra Borchhardt, MD | Medical University of Vienna, Department of Internal Medicine III, Division of Nephrology and Dialysis |
Responsible Party: | Kyra Borchhardt, Priv.-Doz. Dr., Medical University of Vienna |
ClinicalTrials.gov Identifier: | NCT00752401 |
Other Study ID Numbers: |
VitaD-1 EudraCT Number 2008-002807-21 |
First Posted: | September 15, 2008 Key Record Dates |
Last Update Posted: | January 22, 2014 |
Last Verified: | January 2014 |
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 |
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 Cholecalciferol Vitamins Micronutrients Physiological Effects of Drugs Bone Density Conservation Agents Calcium-Regulating Hormones and Agents |