Can High-Dose vitamin d protect kidney transplant patients?
NCT ID NCT01431430
First seen Jun 25, 2026 · Last updated Jun 26, 2026 · Updated 1 time
Summary
This study looked at whether a high dose of vitamin D (100,000 IU) is better than a low dose (12,000 IU) for kidney transplant recipients. The goal was to see if it could reduce new cases of diabetes, heart disease, cancer, or death. Over 500 patients took part for two years, but the results are not yet confirmed as a standard treatment.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Vitamin D3 (cholecalciferol)
- What this could lead to
- If it works, this could show that high-dose vitamin D helps prevent serious complications like diabetes, heart problems, or cancer in kidney transplant recipients.
- What could go wrong
- This is a completed Phase 4 trial, but the results are not yet widely known. The benefits of high-dose vitamin D are still uncertain, and high doses may carry risks like high calcium levels.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
-
Phase 4
Runs after approval, following long-term safety and how well the treatment works in everyday use.
- Participants
-
538 people
The number who actually took part.
- Started
-
Jan 2012
- Finished
-
Feb 2016
- Lead sponsor
-
Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
-
18 to 75 years
- Sex
-
Anyone
- Healthy volunteers
-
Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * Renal transplant recipients between 12 and 48 months after transplantation with a stable renal function during the past 3 months. * Vitamine D insufficiency defined as a concentration of 25OHD lower than 30 ng/ml. * Patient between 18 and 75 years old * Patient capable of understanding the advantages and the risks of the study. * Affiliated with social security health insurance * Written informed consent Exclusion Criteria: * Calcaemia \> 2,7 mmol/l * Phosphataemia \> 1,5 mmol/l * Serum creatinine \> 250 µmol/l * Treatment by an active form of the vitamin D not being able to be interrupted * Transplant of an organ other than the kidney * Type I or type II diabetes mellitus * Past medical history of granulomatosis or active granulomatosis * Primary hyperoxaluria * Malabsorption proved by the liposoluble vitamins * Simultaneous participation in another therapeutic essay * Patients presenting a drug addiction or a psychiatric disorder * Pregnant or breast-feeding women * Vitamin D hyper sensibility
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
-
Georges Pompidou European Hospital
Paris, 75015, France
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Other studies related to the condition(s) this trial covers.