Randomized Controlled Trial of Vitamin D3 in Diabetic Kidney Disease (NCT00552409) | Clinical Trial Compass
CompletedPhase 2/3
Randomized Controlled Trial of Vitamin D3 in Diabetic Kidney Disease
United States22 participantsStarted 2007-12
Plain-language summary
This study will assess the effects of vitamin D3 supplementation (cholecalciferol; 2000 IU daily) on serum calcium levels, circulating vitamin D levels, and markers of kidney disease and cardiovascular risk among people with diabetes mellitus and early kidney disease. Eligibility criteria include type 2 diabetes and stage 1-2 chronic kidney disease, defined by a urine albumin-creatinine ratio 30-300 mg/g and an estimated glomerular filtration rate ≥ 60 mL/min. Participants will be randomly assigned to treatment with vitamin D3 or placebo, each taken by mouth once daily for a study duration of one year. Study medications will be added to standard treatment, including an angiotensin converting enzyme inhibitor and/or angiotensin II receptor blocker. We hypothesize that vitamin D3, compared with placebo: (1) is well-tolerated and safe among people with diabetes and kidney disease; (2) results in adequate attained circulating vitamin D levels; and (3) positively affects markers of kidney disease and cardiovascular risk.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Clinical diagnosis of type 2 diabetes mellitus
* Urine albumin-creatinine ratio 30-1000 mg/g
* Estimated glomerular filtration rate greater than or equal to 60 mL/min
* Treatment with angiotensin converting enzyme inhibitor and/or angiotensin II receptor blocker for greater than or equal to 6 months, with a stable dose for greater than or equal to 3 months
* Blood pressure less than 140/90 (assessed while taking medications)
* Hemoglobin A1c less than 9% (assessed while taking medications)
* 25-hydroxyvitamin D less than 30 ng/mL
Exclusion Criteria:
* Prior dialysis or kidney transplantation
* Known cause of albuminuria other than diabetes
* Planning to leave the area within 12 months
* Life expectancy less than 12 months
* Participation in another clinical trial within 6 months
* Osteoporosis or other established indication for vitamin D therapy
* Vitamin D3 supplement intake greater than 400 IU/day at screening visit
* History of nephrolithiasis
* Serum calcium greater than 10.2 mg/dL
* Dementia, not fluent in English, or unable to provide informed consent without proxy respondent
* Incontinent of urine
* Failure to take greater than or equal to 80% of placebo pills during study run-in
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.