The Effect of Vitamin D Supplementation on Cardiovascular Risk Factors Among Hispanics and African Americans With Type 2 Diabetes Mellitus
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Purpose
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.
| Condition | Intervention |
|---|---|
|
Type 2 Diabetes |
Drug: Cholecalciferol |
| Study Type: | Interventional |
| 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.
| Estimated Enrollment: | 120 |
| 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) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Intervention group
This group will be given Vitamin D for 6 months. All the study participants will be enrolled in this group.
|
Drug: Cholecalciferol
4000 IU or 6000 IU given once daily, orally for 6 months.
Other Name: Vitamin D
|
Detailed 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.
Eligibility| Ages Eligible for Study: | 30 Years to 70 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations| United States, Florida | |
| Human Nutrition Laboratory, Florida International University | Recruiting |
| Miami, Florida, United States, 33199 | |
| Contact: Gustavo Zarini, MS 305-348-6427 gzarini@fiu.edu | |
| Contact: Joel Exebio, MS 305-348-6427 jexeb001@fiu.edu | |
| 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 |
More Information
No publications provided
| Responsible Party: | Fatma Ercanli-Huffman, Dr. Fatma G. Huffman, Florida International University |
| ClinicalTrials.gov Identifier: | NCT01412710 History of Changes |
| Other Study ID Numbers: | FIU-032511-01 |
| Study First Received: | August 7, 2011 |
| Last Updated: | August 21, 2012 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by Florida International University:
|
Type 2 Diabetes Cholecalciferol Vitamin D |
Insulin resistance Cardiovascular disease risk Minorities |
Additional relevant MeSH terms:
|
Diabetes Mellitus Diabetes Mellitus, Type 2 Glucose Metabolism Disorders Metabolic Diseases Endocrine System Diseases Cholecalciferol Vitamin D |
Ergocalciferols Vitamins Micronutrients Growth Substances Physiological Effects of Drugs Pharmacologic Actions Bone Density Conservation Agents |
ClinicalTrials.gov processed this record on June 18, 2013