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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified August 2012 by Florida International University.
Recruitment status was  Recruiting
Sponsor:
Information provided by (Responsible Party):
Fatma Ercanli-Huffman, Florida International University
ClinicalTrials.gov Identifier:
NCT01412710
First received: August 7, 2011
Last updated: August 21, 2012
Last verified: August 2012
  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

Resource links provided by NLM:


Further study details as provided by Florida International University:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01412710

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         
Sponsors and Collaborators
Florida International University
Investigators
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 September 15, 2014