Vitamin D Supplementation on Cardiovascular Risk Factors

Type 2 Diabetes Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01412710
• Other study ID #: FIU-032511-01
• Status: Completed
• Phase: N/A
• First received: August 7, 2011
• Last updated: November 13, 2017
• Start date: July 2011
• Est. completion date: September 2013

Study information

• Verified date: October 2017
• Source: Florida International University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 92
• Est. completion date: September 2013
• Est. primary completion date: September 2013
• Accepts healthy volunteers: No
• Gender: All
• Age group: 30 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Diabetes Mellitus, Type 2
• Type 2 Diabetes

Intervention

Drug:
• Cholecalciferol
4000 IU or 6000 IU given vitamin D3 once daily, orally for 6 months.

Locations

Country	Name	City	State
United States	Human Nutrition Laboratory, Florida International University	Miami	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Florida International University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Blood Lipid	Total cholesterol will be used as surrogate measures for cardiovascular disease risk.	Baseline
Secondary	Glycemic Control	hemoglobin A1C blood test	Baseline