Clinical Trials Logo
  1. Home
  2. Vitamin D Deficiency
  3. NCT00748618
  4. Details
NCT00748618 Clinical Trial

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
Secondary ID
Status Active, not recruiting
Phase N/A
First received
Last updated
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
Health authority
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

Study Design

Related Conditions & MeSH terms

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
See also
  Status Clinical Trial Phase
Active, not recruiting NCT04244474 - Effect of Vitamin D Supplementation on Improvement of Pneumonic Children Phase 1/Phase 2
Recruiting NCT05459298 - ViDES Trial (Vitamin D Extra Supplementation) N/A
Suspended NCT03652987 - Endocrine and Menstrual Disturbances in Women With Polycystic Ovary Syndrome (PCOS)
Completed NCT04476511 - The Efficacy and the Safety of Vitamin D3 30,000 IU for Loading Dose Schedules Phase 3
Completed NCT03920150 - Vitamin D 24'000 IU for Oral Intermittent Supplementation Phase 3
Completed NCT03264625 - The Effects of Oral Vitamin D Supplementation on the Prevention of Peritoneal Dialysis-related Peritonitis Phase 2
Completed NCT04183257 - Effect of Escalating Oral Vitamin D Replacement on HOMA-IR in Vitamin D Deficient Type 2 Diabetics Phase 4
Recruiting NCT05084248 - Vitamin D Deficiency in Adults Following a Major Burn Injury Phase 4
Completed NCT05506696 - Vitamin D Supplementation Study N/A
Completed NCT00092066 - A Study to Evaluate the Safety, Tolerability, and Efficacy of an Investigational Drug and Dietary Supplement in Men and Postmenopausal Women With Osteoporosis (0217A-227) Phase 3
Completed NCT03234218 - Vitamin D Levels in Liver Transplantation Recipients Prospective Observational Study
Completed NCT02714361 - A Study to Investigate the Effect of Vitamin D3 Supplementation on Iron Status in Iron Deficient Women N/A
Completed NCT02906319 - Vitamin D and HbA1c Levels in Diabetic Patients With CKD N/A
Completed NCT03203382 - Corneal Nerve Structure in Sjogren's
Completed NCT02118129 - Vitamin D Among Young Adults: an Intervention Study Using a Mobile 'App'. N/A
Not yet recruiting NCT01419821 - Vitamin D and Its Affect on Growth Rates and Bone Mineral Density Until Age 5 N/A
Completed NCT02275650 - The Role of Narrowband Ultraviolet B Exposure in the Maintenance of Vitamin D Levels During Winter N/A
Completed NCT02187146 - The Effects of Serum Vitamin D and IVF Outcome N/A
Completed NCT01688102 - The Effect of Oral Vitamin D Versus Narrow-Band UV-B Exposure on the Lipid Profile N/A
Completed NCT01651000 - Safety and Efficacy of CTAP101 to Treat Secondary Hyperparathyroidism in Stage 3 or 4 CKD and Vitamin D Insufficiency Phase 3