Vitamin D Supplementation on Cardiovascular Risk Factors
The Effect of Vitamin D Supplementation on Cardiovascular Risk Factors Among Hispanics and African Americans With Type 2 Diabetes
1 other identifier
interventional
92
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable type-2-diabetes
Started Jul 2011
Typical duration for not_applicable type-2-diabetes
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 1, 2011
CompletedFirst Submitted
Initial submission to the registry
August 7, 2011
CompletedFirst Posted
Study publicly available on registry
August 9, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2013
CompletedResults Posted
Study results publicly available
December 12, 2017
CompletedDecember 12, 2017
October 1, 2017
2.2 years
August 7, 2011
August 5, 2017
November 13, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Blood Lipid
Total cholesterol will be used as surrogate measures for cardiovascular disease risk.
Baseline
Secondary Outcomes (1)
Glycemic Control
Baseline
Study Arms (2)
4000 IU group
EXPERIMENTALThis group will be given 4000 IU of vitamin D3 once daily, orally for 6 months.
6000 IU group
EXPERIMENTALThis group will be given 6000 IU vitamin D3 once daily, orally for 6 months.
Interventions
4000 IU or 6000 IU given vitamin D3 once daily, orally for 6 months.
Eligibility Criteria
You may qualify if:
- Type 2 diabetes
- African American or Hispanic
- able to ambulate on their own
- aged between 30 - 70 years
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Human Nutrition Laboratory, Florida International University
Miami, Florida, 33199, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Limitations and Caveats
The study sample was a convenience sample and was not randomly selected from the general adult population. The study lacked a control group.
Results Point of Contact
- Title
- Fatma G. Huffman
- Organization
- Florida International University
Study Officials
- PRINCIPAL INVESTIGATOR
Fatma G Huffman, PhD
Florida International University
Publication Agreements
- PI is Sponsor Employee
- Yes
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Dr. Fatma G. Huffman
Study Record Dates
First Submitted
August 7, 2011
First Posted
August 9, 2011
Study Start
July 1, 2011
Primary Completion
September 1, 2013
Study Completion
September 1, 2013
Last Updated
December 12, 2017
Results First Posted
December 12, 2017
Record last verified: 2017-10