Skip to main content
OpenTrials
Completed

NCT Number: NCT01412710

Vitamin D Supplementation on Cardiovascular Risk Factors

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.

Completed

Looking for future studies?

Notify Me

Key information

Age range

30 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Human Nutrition Laboratory, Florida International University

Miami, Florida, 33199, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Cholecalciferol

Drug

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

Other names: Vitamin D

Primary outcomes

  1. Blood Lipid

    Time frame: Baseline

    Total cholesterol will be used as surrogate measures for cardiovascular disease risk.

Secondary outcomes

  1. Glycemic Control

    Time frame: Baseline

    hemoglobin A1C blood test

Sponsors and collaborators

Lead sponsor

Florida International University

Other

Registry information

Official study title

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

Important dates

Study start
2011
Primary completion
2013
Study completion
2013
First posted
Aug 9, 2011
Registry last updated
Dec 12, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.