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Randomized Controlled Trial of Vitamin D3 in Diabetic Kidney Disease

Primary Purpose

Diabetes Mellitus, Chronic Kidney Disease, Diabetic Kidney Disease

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Cholecalciferol
Placebo
Sponsored by
University of Washington
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Diabetes Mellitus focused on measuring Diabetes mellitus, Type 2 diabetes, Chronic kidney disease, Diabetic kidney disease, Microalbuminuria, Albuminuria, Vitamin D, Cholecalciferol, Kidney, Renal, Cardiovascular, Clinical trial, Placebo

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University of Washington

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Cholecalciferol

Placebo

Arm Description

Outcomes

Primary Outcome Measures

Change in Urine Albumin Excretion
Albumin and creatinine concentrations were measured in 24hr urine collections at baseline, 3 months after randomization, and one year after randomization. We analyzed the difference in log-transformed albumin-creatinine ratio (ACR, mg/g) after randomization (3 months and one year, analyzed together with all available data included) compared with baseline, by treatment assignment. Results are transformed to present percent difference in urine ACR.

Secondary Outcome Measures

Full Information

First Posted
October 31, 2007
Last Updated
April 9, 2014
Sponsor
University of Washington
Collaborators
University of Washington Institute for Translational Health Science (KL2)
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1. Study Identification

Unique Protocol Identification Number
NCT00552409
Brief Title
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

2. Study Status

Record Verification Date
April 2014
Overall Recruitment Status
Completed
Study Start Date
December 2007 (undefined)
Primary Completion Date
June 2010 (Actual)
Study Completion Date
June 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Washington
Collaborators
University of Washington Institute for Translational Health Science (KL2)

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
22 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Cholecalciferol
Arm Type
Experimental
Arm Title
Placebo
Arm Type
Placebo Comparator
Intervention Type
Dietary Supplement
Intervention Name(s)
Cholecalciferol
Intervention Description
2000 IU by mouth daily for one year
Intervention Type
Dietary Supplement
Intervention Name(s)
Placebo
Intervention Description
One softgel daily for one year
Primary Outcome Measure Information:
Title
Change in Urine Albumin Excretion
Description
Albumin and creatinine concentrations were measured in 24hr urine collections at baseline, 3 months after randomization, and one year after randomization. We analyzed the difference in log-transformed albumin-creatinine ratio (ACR, mg/g) after randomization (3 months and one year, analyzed together with all available data included) compared with baseline, by treatment assignment. Results are transformed to present percent difference in urine ACR.
Time Frame
Baseline, 3 months, and one year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ian H de Boer, MD, MS
Organizational Affiliation
University of Washington
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Washington
City
Seattle
State/Province
Washington
ZIP/Postal Code
98195
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
33184642
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.
Results Reference
derived

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Randomized Controlled Trial of Vitamin D3 in Diabetic Kidney Disease

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