Vitamin D Replacement After Kidney Transplant

University of Nebraska116 enrolled

Overview

Vitamin D deficiency accelerates vascular risk progression after kidney transplant.

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

116

Conditions

Kidney Transplantation Vitamin D Deficiency

Interventions

Standard vitamin D3 treatmentDIETARY_SUPPLEMENT

10,000 I.U./wk of vitamin D3 orally for 6 months

High dose vitamin D3 treatmentDIETARY_SUPPLEMENT

50,000 I.U./wk of vitamin D3 orally for 6 months

Eligibility

Sex: ALLMin age: 19 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Kidney transplant more than 6 months ago * 19 years or older * 25-hydroxy vitamin D ≤35 ng/ml 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

Locations (1)

University of Nebraska Medical Center

Omaha, Nebraska, United States

Outcomes

Primary Outcomes

Compare Efficacy and Safety of Two Vitamin D Supplements of These Doses in Normalizing Vitamin D Concentrations.

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.

Time frame: Baseline and 6 months

Secondary Outcomes

The Ability of Vitamin D to Reduce Parathyroid Hormone Concentration.

The 6 month change (6 month - Baseline) in parathyroid hormone concentration was compared between the two treatment arms.

Time frame: baseline and 6 months

The Ability of Vitamin D to Alter Spot Urine Protein-Creatinine Ratio.

The 6 month change (6 month - Baseline) in spot urine protein-creatinine ratio was compared between the two treatment arms.

Time frame: 6 months

The Effect of Vitamin D Supplementation on 6 Month High-sensitivity C-reactive Protein (HsCRP) Levels.

The 6 month change in High-sensitivity C-reactive protein (HsCRP) levels was compared between the two treatment arms.

Time frame: Baseline and 6 months

The Effect of Vitamin D Supplementation on Insulin Resistance at 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.

Time frame: Baseline and 6 months

Data from ClinicalTrials.gov

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