N/A N=90 Randomized Double-blind Treatment

Vitamin D Replacement After Kidney Transplant

Kidney Transplantation · Vitamin D Deficiency

Bottom Line

View on ClinicalTrials.gov: NCT00748618 ↗

Enrolled (actual)

Serious AEs

1.1%

Results posted

Oct 2024

Primary outcome: Primary: Compare Efficacy and Safety of Two Vitamin D Supplements of These Doses in Normalizing Vitamin D Concentrations. — 8; 29 ng/ml

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: Standard vitamin D3 treatment (Dietary_supplement); High dose vitamin D3 treatment (Dietary_supplement)
Age: Adult, Older Adult · 19+ yrs
Sex: All
Sponsor: University of Nebraska
Primary completion: Apr 2012

Outcome Measures

Outcome	Result	p-value
PRIMARY Compare Efficacy and Safety of Two Vitamin D Supplements of These Doses in Normalizing Vitamin D Concentrations.	8; 29	—
SECONDARY The Ability of Vitamin D to Reduce Parathyroid Hormone Concentration.	1.0; -9.0	—
SECONDARY The Ability of Vitamin D to Alter Spot Urine Protein-Creatinine Ratio.	-0.45; -1.95	—
SECONDARY The Effect of Vitamin D Supplementation on 6 Month High-sensitivity C-reactive Protein (HsCRP) Levels.	0.3; 0.15	—
SECONDARY The Effect of Vitamin D Supplementation on Insulin Resistance at 6 Months	-0.6; 0.1	—

Summary

Vitamin D deficiency accelerates vascular risk progression after kidney transplant.

Eligibility Criteria

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) 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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00748618). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.