N/A N=130 Randomized Double-blind Prevention

Effect of Vitamin D3 on Vascular Function

Vitamin D Deficiency

Bottom Line

View on ClinicalTrials.gov: NCT00948298 ↗

Enrolled (actual)

130

Serious AEs

6.2%

Results posted

Jul 2018

Primary outcome: Primary: Pulse Wave Velocity for Vascular Stiffness — 29.3; 27.6 m/s

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: Vitamin D (Drug); Placebo (Drug)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Charles Drew University of Medicine and Science
Primary completion: Jul 2011

Outcome Measures

Outcome	Result	p-value
PRIMARY Pulse Wave Velocity for Vascular Stiffness	29.3; 27.6	—
SECONDARY Changes in Sitting and 24 Ambulatory Blood Pressure	125.8; 126.9; 82.2; 81.1; 128.4; 127.4	—

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 balances the calcium in our body. If our vitamin D levels get too low, it can cause health problems. It may increase our chance of getting high blood pressure or diabetes. Another problem we may have if our vitamin D levels are low is that our blood vessels may not work normally. These are important health problems for anyone. Because African Americans have darker skin, they are more likely than most other racial/ethnic groups to have low vitamin D levels. This study will look at treating African Americans with low vitamin D levels. The goal of this study is to see how vitamin D helps blood vessels work. The investigators will do this study in African Americans who are overweight, have high blood pressure and have low vitamin D levels. The investigators will see if getting the vitamin D level to a normal value will improve how blood vessels work. The dose of vitamin D that will be given in this study is a high dose that is given to people with low vitamin D levels.

Eligibility Criteria

Inclusion Criteria

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 30 ng/ml)
Body mass index (BMI) > 25 kg/m2

Exclusion Criteria

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) 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

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Data sourced from ClinicalTrials.gov (NCT00948298). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.