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| ID | Type | Description | Link |
|---|---|---|---|
| R01DK076092 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) | NIH |
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This research study in adults with established type 2 diabetes will test whether daily vitamin D supplementation affects how the body processes glucose (sugar).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| placebo | Placebo Comparator | One placebo pill daily for 1 year |
|
| cholecalciferol | Active Comparator | One cholecalciferol pill daily for 1 year |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cholecalciferol | Drug |
| ||
| Placebo |
| Measure | Description | Time Frame |
|---|---|---|
| Disposition Index | Disposition index by the insulin secretion sensitivity index-2 (ISSI-2). This is an calculated value which represents the ability of a person's pancreatic beta cells to lower blood glucose. A higher number means the pancreas is better able to secrete insulin and improve glucose levels. | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Change in Glycemia | Change in glycemia (categorical variable, composite outcome) defined as [1] a decrease in diabetes medications or [2] a reduction of equal to or more than 0.4 HbA1c units from baseline without increasing medications. | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Hemoglobin A1c | 12 months | |
| Change in Diabetes Medications | 6 and 12 months | |
| Variability of Response to Vitamin D Supplementation in Subgroups. |
Inclusion Criteria:
Major Exclusion Criteria
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Tufts Medical Center | Boston | Massachusetts | 02111 | United States | ||
| Cincinnati VA Medical Center |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32559272 | Derived | Meng H, Matthan NR, Angellotti E, Pittas AG, Lichtenstein AH. Exploring the effect of vitamin D3 supplementation on surrogate biomarkers of cholesterol absorption and endogenous synthesis in patients with type 2 diabetes-randomized controlled trial. Am J Clin Nutr. 2020 Sep 1;112(3):538-547. doi: 10.1093/ajcn/nqaa149. | |
| 30352748 | Derived | Angellotti E, D'Alessio D, Dawson-Hughes B, Chu Y, Nelson J, Hu P, Cohen RM, Pittas AG. Effect of vitamin D supplementation on cardiovascular risk in type 2 diabetes. Clin Nutr. 2019 Oct;38(5):2449-2453. doi: 10.1016/j.clnu.2018.10.003. Epub 2018 Oct 9. |
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127 participants were enrolled because by the time the 124 "needed" was reached, 3 additional participants were eligible and wanted to be part of the trial.
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| ID | Title | Description |
|---|---|---|
| FG000 | Placebo | One placebo pill daily for 1 year Placebo |
| FG001 | Cholecalciferol | One cholecalciferol pill daily for 1 year Cholecalciferol |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Placebo | One placebo pill daily for 1 year Placebo |
| BG001 | Cholecalciferol | One cholecalciferol pill daily for 1 year Cholecalciferol |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 | Disposition Index | Disposition index by the insulin secretion sensitivity index-2 (ISSI-2). This is an calculated value which represents the ability of a person's pancreatic beta cells to lower blood glucose. A higher number means the pancreas is better able to secrete insulin and improve glucose levels. | Posted | Mean | Standard Error | index | 6 months |
|
12 Months
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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 | Placebo | One placebo pill daily for 1 year Placebo | 0 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| New or prolonged hospitalization | General disorders | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Adverse Event | General disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Anastassios Pittas | Tufts Medical Center | 617-636-5694 | apittas@tuftsmedicalcenter.org |
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| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic 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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|
Variability of response to vitamin D supplementation in subgroups defined by baseline characteristics: (1) race; (3) 25OHD concentration; (3) diabetes treatment. |
| Baseline and 12 months |
| Effect of Vitamin D Supplementation on Blood 25-hydroxyvitaminD Concentration | 12 months |
| Cardiovascular Risk Factors | Cardiovascular risk factors defined as blood pressure, lipid profile, C-reactive protein and urine albumin excretion | 6 and 12 months |
| Effect of Vitamin D Supplementation on Plasma Concentrations of Surrogate Biomarkers of Cholesterol Absorption (Campesterol and β-sitosterol) and Endogenous Synthesis (Lathosterol and Desmosterol) | 6 months |
| Cincinnati |
| Ohio |
| United States |
| 27194308 | Derived | Alzaman NS, Dawson-Hughes B, Nelson J, D'Alessio D, Pittas AG. Vitamin D status of black and white Americans and changes in vitamin D metabolites after varied doses of vitamin D supplementation. Am J Clin Nutr. 2016 Jul;104(1):205-14. doi: 10.3945/ajcn.115.129478. Epub 2016 May 18. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Body Mass Index (BMI) | Mean | Standard Deviation | kg/ m2 |
|
| Units | Counts |
|---|
| Participants |
|
|
| Secondary | Number of Participants With Change in Glycemia | Change in glycemia (categorical variable, composite outcome) defined as [1] a decrease in diabetes medications or [2] a reduction of equal to or more than 0.4 HbA1c units from baseline without increasing medications. | Posted | Count of Participants | Participants | 12 months |
|
|
|
| Other Pre-specified | Hemoglobin A1c | Posted | Mean | Standard Error | percentage | 12 months |
|
|
|
| Other Pre-specified | Change in Diabetes Medications | Not Posted | 6 and 12 months | Participants |
| Other Pre-specified | Variability of Response to Vitamin D Supplementation in Subgroups. | Variability of response to vitamin D supplementation in subgroups defined by baseline characteristics: (1) race; (3) 25OHD concentration; (3) diabetes treatment. | Not Posted | Baseline and 12 months | Participants |
| Other Pre-specified | Effect of Vitamin D Supplementation on Blood 25-hydroxyvitaminD Concentration | Posted | Mean | Standard Deviation | ng/mL | 12 months |
|
|
|
| Other Pre-specified | Cardiovascular Risk Factors | Cardiovascular risk factors defined as blood pressure, lipid profile, C-reactive protein and urine albumin excretion | Not Posted | 6 and 12 months | Participants |
| Other Pre-specified | Effect of Vitamin D Supplementation on Plasma Concentrations of Surrogate Biomarkers of Cholesterol Absorption (Campesterol and β-sitosterol) and Endogenous Synthesis (Lathosterol and Desmosterol) | Not Posted | 6 months | Participants |
| 61 |
| 6 |
| 61 |
| 24 |
| 61 |
| EG001 | Cholecalciferol | One cholecalciferol pill daily for 1 year Cholecalciferol | 0 | 66 | 7 | 66 | 17 | 66 |
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| D004700 | Endocrine System Diseases |
| D011083 |
| Polycyclic Compounds |
| D013261 | Sterols |
| D014807 | Vitamin D |
| D012632 | Secosteroids |
| D008563 | Membrane Lipids |
| D008055 | Lipids |