Vitamin D Replacement After Kidney Transplant

Study Overview
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Brief Summary
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Vitamin D deficiency accelerates vascular risk progression after kidney transplant.

Detailed Description
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This trial will assess the following aims: Time to plateau vitamin D concentrations after initiating vitamin D supplements Safety of vitamin D replacement based on serum and urine calcium Effect of vitamin D on PTH concentration in individuals with elevated parathyroid hormone Effect of vitamin D on markers of insulin resistance and inflammation

Official Title
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Vitamin D Replacement After Kidney Transplant

Conditions
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Kidney Transplantation, Vitamin D Deficiency

Intervention / Treatment
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* Dietary Supplement: vitamin D3
* Dietary Supplement: vitamin D3


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Kidney transplant more than 6 months ago 19 years or older 25-OH vitamin D ≤35 ng/ml Exclusion Criteria: Estimated GFR<30 ml/min/1.73m² Previous small bowel or lung transplant Pancreas transplant less than 6 months ago Cancer or any condition that would change their weight dramatically in the near future such as malabsorption Willing to return for testing every two months Women who are pregnant or < 6 weeks postpartum Calcium > 10.5 mg/dl Phosphate > 4.8 mg/dl Drinking more than 2 alcohol drinks a day or 14 drinks per week History of parathyroid surgery Known granulomatous disease Taking any seizure medication that affects vitamin D Taking zempler ® and/or Rocaltrol ® History of kidney stones in the past 20 years Not on a stable dose of bisphosphonate for the past three months Planning on a pancreas transplant within the next year In any other research study

Ages Eligible for Study
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Minimum Age: 19 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: 1<br>Standard vitamin treatment | Dietary Supplement: vitamin D3<br>* 10,000 I.U./wk of vitamin D3 orally for 6 months<br>* Other names: D3, vitamin D;|
| Active Comparator: 2<br>50,000 I.U. of vitamin D3 | Dietary Supplement: vitamin D3<br>* 50,000 I.U./wk of vitamin D3 orally for 6 months<br>* Other names: D3, vitamin D;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Compare efficacy and safety of two vitamin D supplements of these doses in normalizing vitamin D concentrations. |  | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The ability of vitamin D to reduce parathyroid hormone concentration or change markers of vascular risk, insulin resistance, and/or inflammation, as well as its affect on urine calcium excretion. |  | 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Vascular risk, Kidney transplantation (KTX), Vitamin D deficiency, Cardiovascular Disease (CVD), Parathyroid hormone (PTH), Carotid intima media thickness (CIMT), Insulin resistance (IR)