Vitamin D Replacement After Kidney Transplant

University of Nebraska

Status: Completed

Conditions: Kidney Transplantation; Vitamin D Deficiency

Treatments: Dietary Supplement: Standard vitamin D3 treatment; Dietary Supplement: High dose vitamin D3 treatment

Study type: Interventional

Funder types: Other

Identifiers

NCT00748618

0382-08-FB

Details and patient eligibility

About

Vitamin D deficiency accelerates vascular risk progression after kidney transplant.

Full 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

Enrollment: 116 patients

Sex: All

Ages: 19+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

---

116 participants in 2 patient groups

Standard vitamin treatment

Other group

Description:

10,000 I.U. of vitamin D3 weekly

Treatment:

Dietary Supplement: Standard vitamin D3 treatment

50,000 I.U. of vitamin D3

Active Comparator group

Description:

50,000 I.U. of vitamin D3 weekly

Treatment:

Dietary Supplement: High dose vitamin D3 treatment