Status:
COMPLETED
Effect of Vitamin D3 on Vascular Function
Lead Sponsor:
Charles Drew University of Medicine and Science
Collaborating Sponsors:
National Center for Research Resources (NCRR)
Conditions:
Vitamin D Deficiency
Eligibility:
All Genders
18-70 years
Phase:
NA
Brief Summary
Vitamin D is a natural nutrient. A little comes from our normal daily diet. Most of it comes from our skin after we have been in sunlight. If we have darker skin, we make less vitamin D. Vitamin D bal...
Detailed Description
Cardiovascular Disease (CVD) and related disorders remain the leading cause of death in the nation. Hypovitaminosis D has been linked not only to several cardiovascular (CV) risk factors including hyp...
Eligibility Criteria
Inclusion
- Males or females, 18-70 years of age and self-identified as African-American or Black
- Hypertension
- If a potential study patient is not on treatment, their systolic blood pressure (SBP) must be \> 130 mmHg, or diastolic blood pressure (DBP) \> 85 mmHg, and SBP must be \<160 mmHg and DBP must be \< 105 mmHg.
- If a potential study patient is on treatment then the SBP must be \<160 mmHg and DBP must be \< 105 mmHg
- Screening Vitamin D (D2 and D3 level) between 10 and 25 ng/ml (normal level \> 30 ng/ml)
- Body mass index (BMI) \> 25 kg/m2
Exclusion
- Poorly controlled high blood pressure (SBP \>160 mmHg or DBP \> 105 mmHg)
- Diabetes (fasting blood sugar \> 125 mg/dl, or HbA1c \> 6.5%)
- Screening Vitamin D (D2 and D3 level) \< 10 ng/ml or \> 25 ng/ml
- Estimated glomerular filtration rate (eGFR) \< 45 ml/min
- Evidence of disease resulting in hypercalcemia
- History of kidney stones
- History of drug, alcohol, or illicit substance abuse within the past 6 months
- History of another chronic disease which the investigator feels should preclude the subject from entering the study
- Liver function tests (LFTs) greater than twice the upper limit of normal
- Subjects requiring chronic use of nonsteroidal anti-inflammatory drugs, aspirin, or other drugs that may affect the measurement of reactive oxidative species
- Subjects requiring treatment with other vitamin D preparations containing more than 400 IU of vitamin D
- Subjects requiring chronic use of immunosuppressive therapy or corticosteroids
- Recent (\< 6 months) myocardial infarction, stroke, or hospitalization for congestive heart failure
- Allergy/intolerance: known allergy to oral vitamin D or microcrystalline cellulose
Key Trial Info
Start Date :
July 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2012
Estimated Enrollment :
130 Patients enrolled
Trial Details
Trial ID
NCT00948298
Start Date
July 1 2009
End Date
August 1 2012
Last Update
July 17 2018
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