Clinical trial NCT00552409: Randomized Controlled Trial of Vitamin D3 in Diabetic Kidney Disease
Official title: Randomized Controlled Trial of Vitamin D3 in Diabetic Kidney Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Diabetes Mellitus
Chronic Kidney Disease
Diabetic Kidney Disease
Keywords: Diabetes mellitus
Type 2 diabetes
Chronic kidney disease
Diabetic kidney disease
Microalbuminuria
Albuminuria
Vitamin D
Cholecalciferol
Kidney
Renal
Cardiovascular
Clinical trial
Placebo
Lead sponsor: University of Washington
Sponsor class: OTHER
Collaborators: name: University of Washington Institute for Translational Health Science (KL2)
First posted: 2007-11-01
Enrollment: 22
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.


Eligibility criteria: 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

Primary outcomes:
measure: Change in Urine Albumin Excretion
timeFrame: Baseline, 3 months, and one year
Secondary outcomes:
Other outcomes:
Locations:
city: Seattle
country: United States
facility: University of Washington
state: Washington
Study officials:
affiliation: University of Washington
name: Ian H de Boer, MD, MS
role: PRINCIPAL_INVESTIGATOR
References:
citation: Best CM, Riley DV, Laha TJ, Pflaum H, Zelnick LR, Hsu S, Thummel KE, Foster-Schubert KE, Kuzma JN, Cromer G, Larson I, Hagman DK, Heshelman K, Kratz M, de Boer IH, Hoofnagle AN. Vitamin D in human serum and adipose tissue after supplementation. Am J Clin Nutr. 2021 Jan 4;113(1):83-91. doi: 10.1093/ajcn/nqaa295.