Kidney TransplantationNCT00748618
Vitamin D Replacement After Kidney Transplant
A study testing Standard vitamin D3 treatment and High dose vitamin D3 treatment in people with Kidney Transplantation and Vitamin D Deficiency, run by University of Nebraska at 1 site in United States.
Trial summary
Vitamin D deficiency accelerates vascular risk progression after kidney transplant. Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Kidney Transplantation, Vitamin D Deficiency
- What is being tested?
- Standard vitamin D3 treatment and High dose vitamin D3 treatment
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 116 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Oct 2008to 8 Jun 2023
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Kidney transplant more than 6 months ago
- 19 years or older
- 25-hydroxy vitamin D ≤35 ng/ml
Who cannot join
- 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
Show all 17Show fewer
- 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 locations and contacts
1 site in 1 country.
United States1 site
University of Nebraska Medical Center
Omaha, Nebraska, 68198
About this study
Vitamin D deficiency accelerates vascular risk progression after kidney transplant.
Read the detailed description
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
- Conditions
- Kidney Transplantation, Vitamin D Deficiency
- Being tested
- Standard vitamin D3 treatment, High dose vitamin D3 treatment
- Keywords
- Kidney transplantation (KTX), Vitamin D deficiency, Cardiovascular Disease (CVD), Vascular risk, Parathyroid hormone (PTH), Carotid intima media thickness (CIMT), Insulin resistance (IR)
- Medical subject headings
- Vitamin D Deficiency, Cardiovascular Diseases, Insulin Resistance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Standard vitamin D3 treatmentDietary supplement
10,000 I.U./wk of vitamin D3 orally for 6 months
High dose vitamin D3 treatmentDietary supplement
Also called D3, vitamin D
50,000 I.U./wk of vitamin D3 orally for 6 months
| Study group | Role | What they receive |
|---|---|---|
| Standard vitamin treatment | Other | 10,000 I.U. of vitamin D3 weekly Receives: Dietary Supplement: Standard vitamin D3 treatment |
| 50,000 I.U. of vitamin D3 | Active comparator | 50,000 I.U. of vitamin D3 weekly Receives: Dietary Supplement: High dose vitamin D3 treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Compare Efficacy and Safety of Two Vitamin D Supplements of These Doses in Normalizing Vitamin D Concentrations.
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.
Measured: Baseline and 6 months
Secondary outcomes (4)
The Ability of Vitamin D to Reduce Parathyroid Hormone Concentration.
The 6 month change (6 month - Baseline) in parathyroid hormone concentration was compared between the two treatment arms.
Measured: baseline and 6 months
The Ability of Vitamin D to Alter Spot Urine Protein-Creatinine Ratio.
The 6 month change (6 month - Baseline) in spot urine protein-creatinine ratio was compared between the two treatment arms.
Measured: 6 months
The Effect of Vitamin D Supplementation on 6 Month High-sensitivity C-reactive Protein (HsCRP) Levels.
The 6 month change in High-sensitivity C-reactive protein (HsCRP) levels was compared between the two treatment arms.
Measured: Baseline and 6 months
The Effect of Vitamin D Supplementation on Insulin Resistance at 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.
Measured: Baseline and 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Sep 2008 (estimated)
- Study start1 Oct 2008
- Primary completion1 Apr 2012
- Study completion8 Jun 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Kidney TransplantationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 116 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Nebraska
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jennifer L Larsen, MD, Principal investigator, University of Nebraska
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00748618
- Sponsor's protocol ID
- 0382-08-FB
- Status last verified
- Aug 2024
- First submitted
- 4 Sep 2008
- Last updated
- 26 Oct 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Vitamin D Replacement After Kidney Transplant
- ClinicalTrials.gov ID
- NCT00748618
- Acronym / sponsor ID
- 0382-08-FB
- Conditions
- Kidney Transplantation, Vitamin D Deficiency
- Keywords
- Kidney transplantation (KTX), Vitamin D deficiency, Cardiovascular Disease (CVD), Vascular risk, Parathyroid hormone (PTH), Carotid intima media thickness (CIMT), Insulin resistance (IR)
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 116 participants (actual)
- Lead sponsor
- University of NebraskaUniversity, hospital or other
- Study start
- 1 Oct 2008 (actual)
- Primary completion
- 1 Apr 2012 (actual)
- Study completion
- 8 Jun 2023 (actual)
- First posted
- 8 Sep 2008 (estimated)
- Results
- Posted 26 Oct 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Vitamin D deficiency accelerates vascular risk progression after kidney transplant.
Detailed description
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard vitamin treatment | Other | Dietary Supplement: Standard vitamin D3 treatment10,000 I.U. of vitamin D3 weekly |
| 50,000 I.U. of vitamin D3 | Active comparator | Dietary Supplement: High dose vitamin D3 treatment50,000 I.U. of vitamin D3 weekly |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Kidney transplant more than 6 months ago
- 19 years or older
- 25-hydroxy vitamin D ≤35 ng/ml
Key exclusion criteria (17 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Standard vitamin D3 treatment10,000 I.U./wk of vitamin D3 orally for 6 months | Dietary supplement | Standard vitamin treatment |
| High dose vitamin D3 treatmentAlso: D3, vitamin D50,000 I.U./wk of vitamin D3 orally for 6 months | Dietary supplement | 50,000 I.U. of vitamin D3 |
Primary outcome
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.
4 secondary outcomes
The Ability of Vitamin D to Reduce Parathyroid Hormone Concentration.
Time frame: baseline and 6 months
The Ability of Vitamin D to Alter Spot Urine Protein-Creatinine Ratio.
Time frame: 6 months
The Effect of Vitamin D Supplementation on 6 Month High-sensitivity C-reactive Protein (HsCRP) Levels.
Time frame: Baseline and 6 months
The Effect of Vitamin D Supplementation on Insulin Resistance at 6 Months
Time frame: Baseline and 6 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Oct 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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A Study to Learn About the Effects of Felzartamab Infusions in Adults With Kidney Transplants Who Have Late Isolated Microvascular Inflammation
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Sequential Daratumumab Followed by Telitacicept for the Treatment of ABMR After Kidney Transplantation-A Phase IIa Clinical Trial
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jennifer L Larsen, MD principal investigator
University of Nebraska
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Standard vitamin D3 treatment and High dose vitamin D3 treatment in people with Kidney Transplantation and Vitamin D Deficiency, run by University of Nebraska at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 26 Oct 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Compare Efficacy and Safety of Two Vitamin D Supplements of These Doses in Normalizing Vitamin D Concentrations. (time frame: Baseline and 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Oct 2024.