Vitamin D and Blood Pressure

Hypertension Clinical Trial

Official title:

A Randomized Placebo-controlled Double Blinded Trial to Evaluate Cholecalciferol (Vitamin D3) and Calcitriol Treatment on Reducing Blood Pressure in Middle Aged Adults With Stage I Hypertension and Vitamin D Deficiency

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT00459563
• Other study ID #: 648-2006
• Secondary ID: VAMC Atlanta R&D
• Status: Withdrawn
• Phase: N/A
• First received: April 10, 2007
• Last updated: January 7, 2014
• Start date: March 2007
• Est. completion date: December 2011

Study information

• Verified date: January 2014
• Source: Atlanta VA Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: December 2011
• Est. primary completion date: December 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Hypertension

Intervention

Drug:
• Vitamin D
200,000 IU once weekly for 3 weeks (600,000 IU total dose)
• calcitriol
calcitriol 0.5 mcg twice a day for 1 week
• Placebo
Placebo once a week for 3 weeks

Locations

Country	Name	City	State
United States	VAMC	Decatur	Georgia

Sponsors (2)

Lead Sponsor	Collaborator
Atlanta VA Medical Center	Emory University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Blood pressure		3 Weeks	No
Primary	25(OH)D		3 weeks	Yes
Secondary	Parathyroid hormone		3 weeks	No
Secondary	Renin		3 weeks	No
Secondary	Aldosterone		3 weeks	No
Secondary	Angiotensin II		3 weeks	No