Vitamin D3 Substitution in Vitamin D Deficient Kidney Transplant Recipients

NCT00752401 | Unknown Phase 3

• 2 other identifiers: VitaD-1EudraCT Number 2008-002807-21
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

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.

Conditions

Kidney Transplantation; Vitamin D Deficiency; Renal Osteodystrophy

Keywords

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

Outcome Measures

Primary Outcomes (5)

• The immunologic effects of Vitamin D3 substitution in vitamin D deficient kidney transplant recipients will be evaluated by means of: Glomerular filtration rate

  one year after kidney transplantation

• Number of acute rejection episodes

  one year after kidney transplantation

• Number of infections

  one year after kidney transplantation

• CRP levels

  one year after kidney transplantation

• Courses of calcium levels

  within the first year after kidney transplantation

Secondary Outcomes (1)

• The impact of Vitamin D3 substitution on renal osteopathy will be analyzed by means of absolute bone mineral density (g/cm2)

  within the first year after kidney transplantation

Study Arms (2)

1

ACTIVE COMPARATOR

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

Drug: Cholecalciferol

2

PLACEBO COMPARATOR

Oral placebo solution daily for one year

Drug: Placebo

Interventions

Cholecalciferol 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.

Also known as: Vitamin D3, Oleovit® D3

1

Placebo 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.

2

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Medical University of Vienna: lead

Study Sites (1)

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

Vienna, Austria

Location

Related Publications (1)

• 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.

  PMID: 19480654 DERIVED

MeSH Terms

Conditions

Vitamin D Deficiency; Chronic Kidney Disease-Mineral and Bone Disorder

Interventions

Cholecalciferol

Condition Hierarchy (Ancestors)

Avitaminosis; Deficiency Diseases; Malnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Rickets; Bone Diseases, Metabolic; Bone Diseases; Musculoskeletal Diseases; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Metabolic Diseases; Calcium Metabolism Disorders; Hyperparathyroidism, Secondary; Hyperparathyroidism; Parathyroid Diseases; Endocrine System Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Cholestenes; Cholestanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Sterols; Vitamin D; Secosteroids; Membrane Lipids; Lipids

Study Officials

• Kyra Borchhardt, MD

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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Priv.-Doz. Dr.

Study Record Dates

• First Submitted: September 11, 2008
• First Posted: September 15, 2008
• Study Start: May 1, 2009
• Primary Completion: July 1, 2014
• Study Completion: July 1, 2014
• Last Updated: January 22, 2014

Record last verified: 2014-01

Locations

AU (1)