The Effect of Vitamin D Supplementation on Cardiovascular Risk Factors Among Hispanics and African Americans With Type 2 Diabetes Mellitus
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.
|Study Design:||Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
|Official Title:||The Effect of Vitamin D Supplementation on Cardiovascular Risk Factors Among Hispanics and African Americans With Type 2 Diabetes|
- Cardiovascular disease risk measures [ Time Frame: 6 months ] [ Designated as safety issue: No ]High sensitivity C-reactive protein, Lipid Panel will be used as surrogate measures for cardiovascular disease risk.
- Glycemic Control [ Time Frame: 6 months ] [ Designated as safety issue: No ]A1C, plasma Insulin levels, plasma glucose levels will be used for testing for glycemic control.
|Study Start Date:||July 2011|
|Estimated Study Completion Date:||August 2013|
|Estimated Primary Completion Date:||August 2013 (Final data collection date for primary outcome measure)|
Experimental: Intervention group
This group will be given Vitamin D for 6 months. All the study participants will be enrolled in this group.
4000 IU or 6000 IU given once daily, orally for 6 months.
Other Name: Vitamin D
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01412710
|United States, Florida|
|Human Nutrition Laboratory, Florida International University||Recruiting|
|Miami, Florida, United States, 33199|
|Contact: Gustavo Zarini, MS 305-348-6427 firstname.lastname@example.org|
|Contact: Joel Exebio, MS 305-348-6427 email@example.com|
|Principal Investigator: Fatma E Huffman, PhD|
|Sub-Investigator: Gustavo Zarini, MS|
|Sub-Investigator: Joel Excebio, MS|
|Principal Investigator:||Fatma G Huffman, PhD||Florida International University|