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Completed

NCT Number: NCT00748618

Vitamin D Replacement After Kidney Transplant

Vitamin D deficiency accelerates vascular risk progression after kidney transplant.

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Key information

Conditions

Kidney Transplantation Avitaminosis Cardiovascular Diseases Deficiency Diseases Glucose Metabolism Disorders Hyperinsulinism Insulin Resistance Malnutrition Metabolic Diseases Nutrition Disorders Nutritional and Metabolic Diseases Vitamin D Deficiency

Age range

19 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Nebraska Medical Center

Omaha, Nebraska, 68198, United States

About this study

This trial will assess the following aims:

  • Time to plateau vitamin D concentrations after initiating vitamin D supplements
  • Safety of vitamin D replacement based on serum and urine calcium
  • Effect of vitamin D on PTH concentration in individuals with elevated parathyroid hormone
  • Effect of vitamin D on markers of insulin resistance and inflammation

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Standard vitamin D3 treatment

Dietary Supplement

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

High dose vitamin D3 treatment

Dietary Supplement

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

Other names: D3, vitamin D

Primary outcomes

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

    Time frame: 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 outcomes

  1. The Ability of Vitamin D to Reduce Parathyroid Hormone Concentration.

    Time frame: baseline and 6 months

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

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

    Time frame: 6 months

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

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

    Time frame: Baseline and 6 months

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

  4. The Effect of Vitamin D Supplementation on Insulin Resistance at 6 Months

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

University of Nebraska

Other

Registry information

Important dates

Study start
2008
Primary completion
2012
Study completion
2023
First posted
Sep 8, 2008
Registry last updated
Oct 26, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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