Clinical trial NCT01412710: Vitamin D Supplementation on Cardiovascular Risk Factors
Official title: The Effect of Vitamin D Supplementation on Cardiovascular Risk Factors Among Hispanics and African Americans With Type 2 Diabetes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Type 2 Diabetes
Keywords: Type 2 Diabetes
Cholecalciferol
Vitamin D
Insulin resistance
Cardiovascular disease risk
Minorities
Lead sponsor: Florida International University
Sponsor class: OTHER
First posted: 2011-08-09
Enrollment: 92
Sex: ALL
Minimum age (years): 30
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

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 criteria: 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

Primary outcomes:
measure: Blood Lipid
timeFrame: Baseline
Secondary outcomes:
measure: Glycemic Control
timeFrame: Baseline
Other outcomes:
Locations:
city: Miami
country: United States
facility: Human Nutrition Laboratory, Florida International University
state: Florida
Study officials:
affiliation: Florida International University
name: Fatma G Huffman, PhD
role: PRINCIPAL_INVESTIGATOR
References: