VITA-D: Cholecalciferol substitution in vitamin D deficient kidney transplant recipients: A randomized, placebo-controlled study to evaluate the posttransplant outcome - VITA-D

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2008-002807-21-AT

Enrollment

200

Registered

2008-09-04

Start date

2008-10-15

Completion date

Unknown

Last updated

2018-02-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Vitamin D deficiency in kidney transplant recipients MedDRA version: 9.1 Level: LLT Classification code 10047626 Term: Vitamin D deficiency MedDRA version: 9.1 Level: LLT Classification code 10023438 Term: Kidney transplant

Interventions

Trade Name: Oleovit D3 Tropfen Pharmaceutical Form: Oral solution Pharmaceutical form of the placebo: Oral solution Route of administration of the placebo: Oral use

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Age >18 Deceased donor kidney transplant recipients Only kidney transplant recipients Vitamin D deficiency defined as 25OHD =65 years) yes F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: Re-transplantation for the second time if the patient is highly immunized and therefore included in the apheresis program Re-transplantation for the third time or more often Significant impaired intestinal resorption: malabsorption due to celiac sprue, systemic scleroderma; maldigestion due to chronic pancreatitis, pancreatic insufficiency, pancreas resection, mukoviscidosis, Zollinger-Ellison-syndrom History of inflammatory bowel disease: Crohn’s disease, Ulcerative Colitis Previouse gastrectomy, small bowel or large bowel resection, intestinal bypass surgery Severe liver disease: cirrhosis HIV positive (HAART enhances Vitamin D catabolism)

Design outcomes

Primary

Measure	Time frame
Primary end point(s): The immunologic effects of vitamin D3 substitution in vitamin D deficient kidney transplant recipients will be evaluated by means of - serum creatinine levels within the first year after transplantation, - number of acute rejection episodes within the first year after transplantation, - number of infections within the first year after transplantation, - and CRP levels within the first year after transplantation. ;Main Objective: 1. Does vitamin D3 substitution in vitamin D deficient kidney transplant recipients influence the posttransplant outcome compared to placebo? Hypothesis 1a Vitamin D3 substitution improves graft function compared to placebo analysed by means of serum creatinine within the first year after transplantation. Another surrogate marker used to evaluate the immunomodulatory properties of vitamin D3 is the incidence of acute rejection episodes within the first year after kidney transplantation. Hypothesis 1b Vitamin D3 substitution reduces the frequency and severity (analysed by means of CRP) of posttransplant infections compared to placebo within the first year after kidney transplantation. ;Secondary Objective: 2. Does vitamin D3 substitution influence renal osteopathy analysed using absolute bone mineral density? Hypothesis 2 Vitamin D3 substitution prevents the usual decline in bone mineral density within the first year after transplantation	—

Measure

Time frame

Primary end point(s): The immunologic effects of vitamin D3 substitution in vitamin D deficient kidney transplant recipients will be evaluated by means of - serum creatinine levels within the first year after transplantation, - number of acute rejection episodes within the first year after transplantation, - number of infections within the first year after transplantation, - and CRP levels within the first year after transplantation. ;Main Objective: 1. Does vitamin D3 substitution in vitamin D deficient kidney transplant recipients influence the posttransplant outcome compared to placebo? Hypothesis 1a Vitamin D3 substitution improves graft function compared to placebo analysed by means of serum creatinine within the first year after transplantation. Another surrogate marker used to evaluate the immunomodulatory properties of vitamin D3 is the incidence of acute rejection episodes within the first year after kidney transplantation. Hypothesis 1b Vitamin D3 substitution reduces the frequency and severity (analysed by means of CRP) of posttransplant infections compared to placebo within the first year after kidney transplantation. ;Secondary Objective: 2. Does vitamin D3 substitution influence renal osteopathy analysed using absolute bone mineral density? Hypothesis 2 Vitamin D3 substitution prevents the usual decline in bone mineral density within the first year after transplantation

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Countries

Austria

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026