Vitamin D Supplementation on Cardiovascular Risk Factors

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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The Effect of Vitamin D Supplementation on Cardiovascular Risk Factors Among Hispanics and African Americans With Type 2 Diabetes

Conditions
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Type 2 Diabetes

Intervention / Treatment
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* Drug: Cholecalciferol


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Type 2 diabetes African American or Hispanic able to ambulate on their own aged between 30 - 70 years Exclusion Criteria: Taking Supplemental Vitamin D Pregnant or Lactating women Receiving insulin therapy Not participating in other drug trials HIV/ hepatitis/ cancer/ liver disease/ heart failure/ any recent surgery/ mental illness/ epilepsy/ any GI or malabsorption disorders Kidney failure or on dialysis

Ages Eligible for Study
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Minimum Age: 30 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 4000 IU group<br>This group will be given 4000 IU of vitamin D3 once daily, orally for 6 months. | Drug: Cholecalciferol<br>* 4000 IU or 6000 IU given vitamin D3 once daily, orally for 6 months.<br>* Other names: Vitamin D;|
| Experimental: 6000 IU group<br>This group will be given 6000 IU vitamin D3 once daily, orally for 6 months. | Drug: Cholecalciferol<br>* 4000 IU or 6000 IU given vitamin D3 once daily, orally for 6 months.<br>* Other names: Vitamin D;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Blood Lipid | Total cholesterol will be used as surrogate measures for cardiovascular disease risk. | Baseline | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Glycemic Control | hemoglobin A1C blood test | Baseline | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Type 2 Diabetes, Cholecalciferol, Vitamin D, Insulin resistance, Cardiovascular disease risk, Minorities