Vitamin D Supplementation on Cardiovascular Risk Factors

NCT ID: NCT01412710

Last Updated: 2017-12-12

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 92 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-07-31
• Study Completion Date: 2013-09-30

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.

Conditions

Type 2 Diabetes

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

4000 IU group

This group will be given 4000 IU of vitamin D3 once daily, orally for 6 months.

Group Type: EXPERIMENTAL

Cholecalciferol

Intervention Type: DRUG

4000 IU or 6000 IU given vitamin D3 once daily, orally for 6 months.

6000 IU group

This group will be given 6000 IU vitamin D3 once daily, orally for 6 months.

Group Type: EXPERIMENTAL

Cholecalciferol

Intervention Type: DRUG

4000 IU or 6000 IU given vitamin D3 once daily, orally for 6 months.

Interventions

Cholecalciferol

4000 IU or 6000 IU given vitamin D3 once daily, orally for 6 months.

Intervention Type: DRUG

Other Intervention Names

Vitamin D

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

• Minimum Eligible Age: 30 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Florida International University

OTHER

Sponsor Role: lead

Responsible Party

Fatma Ercanli-Huffman

Dr. Fatma G. Huffman

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Fatma G Huffman, PhD

Role: PRINCIPAL_INVESTIGATOR

Florida International University

Locations

Human Nutrition Laboratory, Florida International University

Miami, Florida, United States

Countries

United States

Other Identifiers

FIU-032511-01

Identifier Type: -

Identifier Source: org_study_id