Vitamin D Replacement After Kidney Transplant

Vitamin D Deficiency Clinical Trial

Official title:

Vitamin D Replacement After Kidney Transplant

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT00748618
• Other study ID #: 382-08-FB
• Status: Active, not recruiting
• Phase: N/A
• Start date: October 2008
• Est. completion date: June 2023

Study information

• Verified date: October 2022
• Source: University of Nebraska
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Vitamin D deficiency accelerates vascular risk progression after kidney transplant.

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 information / eligibility

• Status: Active, not recruiting
• Enrollment: 165
• Est. completion date: June 2023
• Est. primary completion date: April 2012
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Kidney Transplantation
• Vitamin D Deficiency

Intervention

Dietary Supplement:
• vitamin D3
10,000 I.U./wk of vitamin D3 orally for 6 months
• vitamin D3
50,000 I.U./wk of vitamin D3 orally for 6 months

Locations

Country	Name	City	State
United States	University of Nebraska Medical Center	Omaha	Nebraska

Sponsors (1)

Lead Sponsor	Collaborator
University of Nebraska

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Compare efficacy and safety of two vitamin D supplements of these doses in normalizing vitamin D concentrations.		6 months
Secondary	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