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| ID | Type | Description | Link |
|---|---|---|---|
| 1KL2RR025015-01 | U.S. NIH Grant/Contract | View source | |
| 5P30DK017047 | U.S. NIH Grant/Contract | View source | |
| 07-5221-A 01 |
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| Name | Class |
|---|---|
| University of Washington Institute for Translational Health Science (KL2) | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cholecalciferol | Experimental |
| |
| Placebo | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cholecalciferol | Dietary Supplement | 2000 IU by mouth daily for one year |
| |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline, 3 months, and one year |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ian H de Boer, MD, MS | University of Washington | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Washington | Seattle | Washington | 98195 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33184642 | Derived | 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. |
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Of the 93 participants who provided informed consent, 63 were ineligible, 8 withdrew prior to randomization, and 22 were randomized to treatment.
Ninety-three participants from medical clinics associated from the University of Washington (Seattle, WA) provided informed consent for this study between February, 2008 through June, 2009.
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| ID | Title | Description |
|---|---|---|
| FG000 | Cholecalciferol | 2000 IU by mouth daily for one year |
| FG001 | Placebo | One softgel daily for one year |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Cholecalciferol | 2000 IU by mouth daily for one year |
| BG001 | Placebo | One softgel daily for one year |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | All participants were analyzed | Posted | Mean | 95% Confidence Interval | percent difference | Baseline, 3 months, and one year |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Cholecalciferol | 2000 IU by mouth daily for one year |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| sinus infection | Infections and infestations |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Ian de Boer | University of Washington | 206-616-5403 | deboer@u.washington.edu |
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| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D051436 | Renal Insufficiency, Chronic |
| D003928 | Diabetic Nephropathies |
| D003924 | Diabetes Mellitus, Type 2 |
| D000419 | Albuminuria |
| ID | Term |
|---|---|
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
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| ID | Term |
|---|---|
| D002762 | Cholecalciferol |
| ID | Term |
|---|---|
| D002782 | Cholestenes |
| D002776 | Cholestanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
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| Placebo |
| Dietary Supplement |
One softgel daily for one year |
|
| BG002 |
| Total |
Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
One softgel daily for one year |
|
|
|
| 0 |
| 11 |
| 8 |
| 11 |
| EG001 | Placebo | One softgel daily for one year | 0 | 11 | 10 | 11 |
| carpal tunnel syndrome | Musculoskeletal and connective tissue disorders |
|
| frozen shoulder | Musculoskeletal and connective tissue disorders |
|
| ovarian cyst | General disorders |
|
| vaginitis | Infections and infestations |
|
| sleep apnea | General disorders |
|
| upper respiratory infection | Infections and infestations |
|
| toe amputation | Musculoskeletal and connective tissue disorders |
|
| diarrhea | Gastrointestinal disorders |
|
| fecal incontinence | Gastrointestinal disorders |
|
| dizziness | General disorders |
|
| hyperglycemia | Endocrine disorders |
|
| edema | General disorders |
|
| elevated blood pressure | Cardiac disorders |
|
| shoulder pain | Musculoskeletal and connective tissue disorders |
|
| low blood pressure | Cardiac disorders |
|
| lack of energy | General disorders |
|
| decreased mood | Psychiatric disorders |
|
| knee pain | Musculoskeletal and connective tissue disorders |
|
| anhedonia | Psychiatric disorders |
|
| burned throat | Injury, poisoning and procedural complications |
|
| cough | General disorders |
|
| ear infection | Ear and labyrinth disorders |
|
| rash | General disorders |
|
| dyspnea | General disorders |
|
| abdominal swelling | General disorders |
|
| glaucoma | Eye disorders |
|
| multiple sclerosis flair | Immune system disorders |
|
| cellulitis | Infections and infestations |
|
| endovenous laser treatment | General disorders |
|
| trigger finger | Musculoskeletal and connective tissue disorders |
|
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| D051437 | Renal Insufficiency |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D048909 | Diabetes Complications |
| D011507 | Proteinuria |
| D014555 | Urination Disorders |
| D020924 | Urological Manifestations |
| D012816 | Signs and Symptoms |
| D011083 |
| Polycyclic Compounds |
| D013261 | Sterols |
| D014807 | Vitamin D |
| D012632 | Secosteroids |
| D008563 | Membrane Lipids |
| D008055 | Lipids |