Vitamin D and Blood Pressure

Atlanta VA Medical Center

Status: Withdrawn

Conditions: Hypertension

Treatments: Drug: calcitriol; Drug: Vitamin D; Drug: Placebo

Study type: Interventional

Funder types: Other; Other U.S. Federal agency

Identifiers

NCT00459563

VAMC Atlanta R&D AREF 283001

648-2006

Details and patient eligibility

About

Vitamin D is a natural nutrient in normal daily diet. It can also be made in the skin after exposure to sunlight and is essential for maintaining normal calcium balance. One past study has suggested that vitamin D may be helpful for blood pressure. This study will test whether pills containing cholecalciferol (a form of vitamin D) or calcitriol (the active form of vitamin D) can treat high blood pressure. The investigators plan to enroll up to 80 subjects at the Atlanta VA Medical Center. Participation in the study is expected to last up to 4 weeks. Subjects will be assigned to cholecalciferol, calcitriol or placebo). A 24-hour blood pressure monitor will be worn at the beginning and end of the study to determine blood pressure changes. Renin, PTH, angiotensin-II, and aldosterone levels will also be measured at the beginning and end of the study.

Sex: All

Ages: 18 to 80 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Participants must be over the age of 18
• Vitamin D levels between 10 and 30 ng/ml
• Systolic blood pressure between 130 and 150 mmHg

Exclusion criteria

• Current use of anti-hypertensive medication
• Inability to understand the consent form
• Inability to return ABP monitor within 24-48 hours after visit
• Alcohol dependence
• Diagnosis of chronic kidney disease
• History of heart disease
• History of stroke
• Inability to comply with study protocol
• Current treatment for cancer
• Narcotic dependence
• Current use of greater than 2000 IU of vitamin D
• Pregnant

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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0 participants in 3 patient groups, including a placebo group

Placebo

Placebo Comparator group

Treatment:

Drug: Placebo

Cholecalciferol

Active Comparator group

Description:

Cholecalciferol

Treatment:

Drug: Vitamin D

Calcitriol

Active Comparator group

Description:

Calcitriol

Treatment:

Drug: calcitriol