Vitamin D and Blood Pressure

Not Applicable

Withdrawn

• Conditions: Hypertension
• Interventions: Drug: Placebo; Drug: Vitamin D; Drug: calcitriol

• Registration Number: NCT00459563
• Lead Sponsor: Atlanta VA Medical Center

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2007-03
• Study First Submitted: 2007-04-10
• Study First Submitted QC: 2007-04-11
• Study First Posted: 2007-04-12
• Primary Completion: 2011-12
• Study Completion: 2011-12
• Status Verified: 2014-01
• Last Update Submitted: 2014-01-07
• Last Update Posted: 2014-01-08

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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

Read More

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

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	-
Cholecalciferol	Vitamin D	Cholecalciferol
Calcitriol	calcitriol	Calcitriol

Primary Outcome Measures

Name	Time	Method
Blood pressure	3 Weeks
25(OH)D	3 weeks

Secondary Outcome Measures

Name	Time	Method
Parathyroid hormone	3 weeks
Renin	3 weeks
Aldosterone	3 weeks
Angiotensin II	3 weeks

Trial Locations

Locations (1)

VAMC; 🇺🇸 Decatur, Georgia, United States