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The purpose of the present pilot study is to determine the effect of vitamin D supplementation (4000 IU or 6000 IU once daily for 6 months) on reducing heart disease risk and in improving blood glucose control in type 2 Diabetes subjects . The investigators are working with Hispanics and African Americans living in Miami, Florida.
Insufficient vitamin D levels have been found in subjects with type 2 diabetes (T2D). Similarly, a negative association between serum vitamin D levels and insulin resistance has been reported in a large sample representative of the adult US population and in subjects at risk for T2D. In addition, a strong association between hypovitaminosis D and hypertriglyceridemia has been demonstrated in studies done in US adult population.
Literature has indicated that subjects with T2D and insulin resistance (IR) are more likely to develop arteriosclerosis and all of the complications related to this condition, such as myocardial infarction and stroke.
These findings have increased the interest about the effect of vitamin D on metabolic abnormalities grouped under the term "cardiovascular disease (CVD) risk factors", which includes hypertension, dyslipidemia, obesity, glucose intolerance, inflammation and T2D which is in itself a risk factor for CVD.
Therefore, the purpose of the present pilot study will be to determine the effect of supplemental vitamin D intake (4000 IU or 6000 IU of Cholecalciferol daily for 6 months) on CVD risk markers and glycemic control; primarily lipid panel, insulin resistance, and glycosylated hemoglobin (A1C), in a sample of Hispanics and African-Americans with T2D and vitamin D insufficiency. If repletion of vitamin D level improves insulin resistance, glycemic control, inflammation, hypertension, dyslipidaemia or kidney functions, it may prevent the development of CVD events and decrease T2D complications.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 4000 IU group | Experimental | This group will be given 4000 IU of vitamin D3 once daily, orally for 6 months. |
|
| 6000 IU group | Experimental | This group will be given 6000 IU vitamin D3 once daily, orally for 6 months. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cholecalciferol | Drug | 4000 IU or 6000 IU given vitamin D3 once daily, orally for 6 months. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Blood Lipid | Total cholesterol will be used as surrogate measures for cardiovascular disease risk. | Baseline |
| Measure | Description | Time Frame |
|---|---|---|
| Glycemic Control | hemoglobin A1C blood test | Baseline |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Fatma G Huffman, PhD | Florida International University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Human Nutrition Laboratory, Florida International University | Miami | Florida | 33199 | United States |
15 participants did not qualified due to normal levels of serum vitamin D, 25-hydroxy vitamin D [25(OH)D].
Subjects were recruited from two clinics in Miami-Dade County, Florida (Borinquen Health Care Center and Clinical Care Medical Center) from July 2011 to March 2013 using flyers explaining the purpose of the study.
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| ID | Title | Description |
|---|---|---|
| FG000 | 4000 IU Group | This group received 4000 IU/day vitamin D3 for 6 months. |
| FG001 | 6000 IU Group | This group received 6000 IU/day vitamin D3 for 6 months. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Hispanic or Latino and African-Americans, age 30-70 years old, with type 2 diabetes.
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| ID | Title | Description |
|---|---|---|
| BG000 | 4000 IU Group | This group will be given cholecalciferol 4000 IU once daily, orally for 6 months. |
| BG001 | 6000 IU Group | This group will be given cholecalciferol 6000 IU once daily, orally for 6 months. |
| 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 | Blood Lipid | Total cholesterol will be used as surrogate measures for cardiovascular disease risk. | Total cholesterol baseline. | Posted | Mean | Standard Deviation | mg/dl | Baseline |
|
|
Data were collected for 6 months
No adverse events or signs of toxicity reported by any of the participants throughout the study.
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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 | 4000 IU Vitamin D3/Day | This group will be given cholecalciferol 4000 IU once daily, orally for 6 months. |
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The study sample was a convenience sample and was not randomly selected from the general adult population. The study lacked a control group.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Fatma G. Huffman | Florida International University | 305-348-3877 | huffmanf@fiu.edu |
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| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| D007333 | Insulin Resistance |
| 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 |
| D014807 | Vitamin D |
| ID | Term |
|---|---|
| D002782 | Cholestenes |
| D002776 | Cholestanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
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| 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 |
|
| Region of Enrollment | Count of Participants | Participants |
|
|
|
| Secondary | Glycemic Control | hemoglobin A1C blood test | A1C baseline. | Posted | Mean | Standard Deviation | Percentage of Hemoglobin | Baseline |
|
|
|
| 0 |
| 50 |
| 0 |
| 50 |
| 0 |
| 50 |
| EG001 | 6000 IU Vitamin D3/Day | This group will be given cholecalciferol 6000 IU once daily, orally for 6 months. | 0 | 27 | 0 | 27 | 0 | 27 |
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| D004700 | Endocrine System Diseases |
| D006946 | Hyperinsulinism |
| D011083 |
| Polycyclic Compounds |
| D013261 | Sterols |
| D012632 | Secosteroids |
| D008563 | Membrane Lipids |
| D008055 | Lipids |