Vitamin D3 Substitution in Vitamin D Deficient Kidney Transplant Recipients

NCT ID: NCT00752401

Last Updated: 2014-01-22

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE3
• Total Enrollment: 200 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-05-31
• Study Completion Date: 2014-07-31

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.

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.

Conditions

Kidney Transplantation; Vitamin D Deficiency; Renal Osteodystrophy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

1

6800 IU/day of Cholecalciferol (Vitamin D3) orally for one year

Group Type: ACTIVE_COMPARATOR

Cholecalciferol

Intervention Type: DRUG

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.

2

Oral placebo solution daily for one year

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

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.

Interventions

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.

Intervention Type: 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.

Intervention Type: DRUG

Other Intervention Names

Vitamin D3; Oleovit® D3

Eligibility 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Medical University of Vienna

OTHER

Sponsor Role: lead

Responsible Party

Kyra Borchhardt

Priv.-Doz. Dr.

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Kyra Borchhardt, MD

Role: PRINCIPAL_INVESTIGATOR

Medical University of Vienna, Department of Internal Medicine III, Division of Nephrology and Dialysis

Locations

Medical University of Vienna, Department of Internal Medicine III, Division of Nephrology and Dialysis

Vienna, , Austria

Countries

Austria

References

Thiem U, Heinze G, Segel R, Perkmann T, Kainberger F, Muhlbacher F, Horl 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.

Reference Type: DERIVED

PMID: 19480654 (View on PubMed)

Other Identifiers

EudraCT Number 2008-002807-21

Identifier Type: -

Identifier Source: secondary_id

VitaD-1

Identifier Type: -

Identifier Source: org_study_id