Vitamin D Supplementation on Cardiovascular Risk Factors
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About
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.
Full description
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.
Enrollment
Sex
Ages
Volunteers
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
Trial design
Primary purpose
Allocation
Interventional model
Masking
92 participants in 2 patient groups
Trial contacts and locations
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Data sourced from clinicaltrials.gov
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