Vitamin D Replacement After Kidney Transplant

Not Applicable

Completed

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

Detailed Description: This trial will assess the following aims:

1. Time to plateau vitamin D concentrations after initiating vitamin D supplements

2. Safety of vitamin D replacement based on serum and urine calcium

3. Effect of vitamin D on PTH concentration in individuals with elevated parathyroid hormone

4. Effect of vitamin D on markers of insulin resistance and inflammation

Recruitment & Eligibility

Inclusion Criteria

Exclusion Criteria

Estimated Glomerular filtration rate (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 Zemplar ® 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

Arm && Interventions

Group	Intervention	Description
1	vitamin D3	Standard vitamin treatment
2	vitamin D3	50,000 I.U. of vitamin D3

Primary Outcome Measures

Name	Time	Method
Compare Efficacy and Safety of Two Vitamin D Supplements of These Doses in Normalizing Vitamin D Concentrations.	Baseline and 6 months	The 6 month change (6 month - Baseline) was compared between the two treatment arms of vitamin D supplements for normalizing vitamin D concentrations. Higher change values indicate improvement in vitamin D levels.

Secondary Outcome Measures

Name	Time	Method
The Ability of Vitamin D to Reduce Parathyroid Hormone Concentration.	baseline and 6 months	The 6 month change (6 month - Baseline) in parathyroid hormone concentration was compared between the two treatment arms.
The Ability of Vitamin D to Alter Spot Urine Protein-Creatinine Ratio.	6 months	The 6 month change (6 month - Baseline) in spot urine protein-creatinine ratio was compared between the two treatment arms.
The Effect of Vitamin D Supplementation on 6 Month High-sensitivity C-reactive Protein (HsCRP) Levels.	Baseline and 6 months	The 6 month change in High-sensitivity C-reactive protein (HsCRP) levels was compared between the two treatment arms.
The Effect of Vitamin D Supplementation on Insulin Resistance at 6 Months	Baseline and 6 months	The 6 month change (6 month - Baseline) in insulin resistance was assessed with HOMA-IR (Homeostatic Model Assessment-Insulin Resistance), which is calculated by fasting glucose (mg/dL) X fasting insulin (mU/L) /405.