Effect of Vitamin D3 on Vascular Function

NCT00948298 | Completed Results DMC

• 2 other identifiers: IRB#08-05-2170-01U54RR022762
• Study Type: interventional
• Target: 130
• Locations: 0 countries
• Sites: N/A

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 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.

Conditions

Vitamin D Deficiency

Keywords

cardiovascular disease; vitamin D; african american; low vitamin D levels

Outcome Measures

Primary Outcomes (1)

• Pulse Wave Velocity for Vascular Stiffness

  The primary outcome variable is pulse wave velocity (PWV) for vascular stiffness. The hypothesis is that a greater decrease in the PWV will occur with the Vitamin D3 treatment. PWV is the speed at which the arterial pulse wave travels through the arteries in the cardiovascular system. It is considered the gold standard for the assessment of arterial elastance (stiffness) and determined by radial artery applanation tonometry using the SphygmoCor device.

  12 Weeks

Secondary Outcomes (1)

• Changes in Sitting and 24 Ambulatory Blood Pressure

  12 weeks

Study Arms (2)

Placebo

PLACEBO COMPARATOR

Drug: Placebo

Vitamin D

EXPERIMENTAL

Drug: Vitamin D

Interventions

Vitamin D DRUG

Two 50,000 IU tablets of oral Vitamin D3 will be given every 4 weeks.

Vitamin D

Placebo DRUG

Two tablets of oral placebo (microcrystalline cellulose),matching in appearance to the Vitamin D3, will be given every 4 weeks.

Placebo

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Charles Drew University of Medicine and Science: lead
• National Center for Research Resources (NCRR): collaborator

MeSH Terms

Conditions

Vitamin D Deficiency; Cardiovascular Diseases

Interventions

Vitamin D

Condition Hierarchy (Ancestors)

Avitaminosis; Deficiency Diseases; Malnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Secosteroids; Steroids; Fused-Ring Compounds; Polycyclic Compounds

Results Point of Contact

• Title: Dr. David Martins
• Organization: Charles Drew University of Medicine and Science

davidmartins@cdrewu.edu

323-568-3353

Study Officials

• David Martins, MD

  Charles Drew University of Medicine and Science

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Medicine

Study Record Dates

• First Submitted: July 28, 2009
• First Posted: July 29, 2009
• Study Start: July 1, 2009
• Primary Completion: July 1, 2011
• Study Completion: August 1, 2012
• Last Updated: July 17, 2018
• Results First Posted: July 17, 2018

Record last verified: 2018-06