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Vitamin D Supplementation on Cardiovascular Risk Factors

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ClinicalTrials.gov Identifier: NCT01412710
Recruitment Status : Completed
First Posted : August 9, 2011
Results First Posted : December 12, 2017
Last Update Posted : December 12, 2017
Sponsor:
Information provided by (Responsible Party):

Study Description
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.

Condition or disease Intervention/treatment
Type 2 Diabetes Drug: Cholecalciferol

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.


Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 92 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: The Effect of Vitamin D Supplementation on Cardiovascular Risk Factors Among Hispanics and African Americans With Type 2 Diabetes
Study Start Date : July 2011
Primary Completion Date : September 2013
Study Completion Date : September 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Vitamin D
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Experimental: 4000 IU group
This group will be given 4000 IU of vitamin D3 once daily, orally for 6 months.
Drug: Cholecalciferol
4000 IU or 6000 IU given vitamin D3 once daily, orally for 6 months.
Other Name: Vitamin D
Experimental: 6000 IU group
This group will be given 6000 IU vitamin D3 once daily, orally for 6 months.
Drug: Cholecalciferol
4000 IU or 6000 IU given vitamin D3 once daily, orally for 6 months.
Other Name: Vitamin D


Outcome Measures

Primary Outcome Measures :
  1. Blood Lipid [ Time Frame: Baseline ]
    Total cholesterol will be used as surrogate measures for cardiovascular disease risk.


Secondary Outcome Measures :
  1. Glycemic Control [ Time Frame: Baseline ]
    hemoglobin A1C blood test


Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   30 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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
  • Kidney failure or on dialysis
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01412710


Locations
United States, Florida
Human Nutrition Laboratory, Florida International University
Miami, Florida, United States, 33199
Sponsors and Collaborators
Florida International University
Investigators
Principal Investigator: Fatma G Huffman, PhD Florida International University
More Information

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
First Posted: August 9, 2011    Key Record Dates
Results First Posted: December 12, 2017
Last Update Posted: December 12, 2017
Last Verified: October 2017

Keywords provided by Fatma Ercanli-Huffman, Florida International University:
Type 2 Diabetes
Cholecalciferol
Vitamin D
Insulin resistance
Cardiovascular disease risk
Minorities

Additional relevant MeSH terms:
Diabetes Mellitus, Type 2
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Vitamins
Vitamin D
Ergocalciferols
Cholecalciferol
Micronutrients
Growth Substances
Physiological Effects of Drugs
Bone Density Conservation Agents