Vitamin D and Blood Pressure

• Sponsor: Atlanta VA Medical Center (U.S. Fed)
• Overall Status: Withdrawn
• CT.gov ID: NCT00459563
• Collaborator: Emory University (Other)
• Enrollment: 0
• Location: 1
• Arms: 3
• Duration (Months): 57
• Patients Per Site Per Month: 0

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Hypertension	Drug: Vitamin D; Drug: calcitriol; Drug: Placebo	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 0 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Participant)
• Primary Purpose: Treatment
• 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
• Study Start Date: Mar 1, 2007
• Actual Primary Completion Date: Dec 1, 2011
• Actual Study Completion Date: Dec 1, 2011

Arms and Interventions

Arm	Intervention/Treatment
Placebo Comparator: Placebo	Drug: Placebo; Placebo once a week for 3 weeks
Active Comparator: Cholecalciferol Cholecalciferol	Drug: Vitamin D; 200,000 IU once weekly for 3 weeks (600,000 IU total dose)
Active Comparator: Calcitriol Calcitriol	Drug: calcitriol; calcitriol 0.5 mcg twice a day for 1 week

Outcome Measures

Primary Outcome Measures

1. Blood pressure [3 Weeks]

2. 25(OH)D [3 weeks]

Secondary Outcome Measures

1. Parathyroid hormone [3 weeks]

2. Renin [3 weeks]

3. Aldosterone [3 weeks]

4. Angiotensin II [3 weeks]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 80 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	VAMC	Decatur	Georgia	United States	30033

Sponsors and Collaborators

• Atlanta VA Medical Center
• Emory University

Investigators

• Principal Investigator: Vin Tangpricha, MD/PhD, Emory University/VAMC
• Study Director: Suzanne E Judd, MPH, Emory University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Vin Tangpricha, Staff Physician, Atlanta VA Medical Center
• ClinicalTrials.gov Identifier: NCT00459563
• Other Study ID Numbers: 648-2006; VAMC Atlanta R&D AREF 283001
• First Posted: Apr 12, 2007
• Last Update Posted: Jan 8, 2014
• Last Verified: Jan 1, 2014

• Keywords provided by Vin Tangpricha, Staff Physician, Atlanta VA Medical Center: vitamin D; blood pressure; hypertension; Vitamin D insufficient; Systolic blood pressure between 130 and 150 mmHg
• Additional relevant MeSH terms: Hypertension; Vitamin D; Calcitriol

Study Results

No Results Posted as of Jan 8, 2014