|
|
Home
Search
Study Topics
Glossary
|
 |
|
|
|
|
|
|
|
|
|
|
|
|
||||||||||||||||||||||||||||||||||||
| Sponsors and Collaborators: |
Atlanta VA Medical Center Emory University |
|---|---|
| Information provided by: | Atlanta VA Medical Center |
| ClinicalTrials.gov Identifier: | NCT00459563 |
Purpose
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 | Intervention |
|---|---|
|
Hypertension |
Drug: Vitamin D Drug: calcitriol Drug: Placebo |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Single Blind (Subject), Placebo Control, Parallel Assignment, Safety/Efficacy Study |
| 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 |
| Estimated Enrollment: | 80 |
| Study Start Date: | March 2007 |
| Estimated Study Completion Date: | December 2009 |
| Estimated Primary Completion Date: | December 2009 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Placebo: Placebo Comparator |
Drug: Placebo
Placebo once a week for 3 weeks
|
|
Cholecalciferol: Active Comparator
Cholecalciferol
|
Drug: Vitamin D
200,000 IU once weekly for 3 weeks (600,000 IU total dose)
|
|
Calcitriol: Active Comparator
Calcitriol
|
Drug: calcitriol
calcitriol 0.5 mcg twice a day for 1 week
|
Eligibility| Ages Eligible for Study: | 18 Years to 80 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| United States, Georgia | |
| VAMC | |
| Decatur, Georgia, United States, 30033 | |
| Principal Investigator: | Vin Tangpricha, MD/PhD | Emory University/VAMC |
| Study Director: | Suzanne E Judd, MPH | Emory University |
More Information
| Responsible Party: | Atlanta VA Medical Center ( Vin Tangpricha ) |
| Study ID Numbers: | 648-2006, VAMC Atlanta R&D AREF 283001 |
| Study First Received: | April 10, 2007 |
| Last Updated: | April 9, 2009 |
| ClinicalTrials.gov Identifier: | NCT00459563 History of Changes |
| Health Authority: | United States: Federal Government |
|
vitamin D blood pressure hypertension Vitamin D insufficient Systolic blood pressure between 130 and 150 mmHg |
|
Vitamin D Deficiency Cholecalciferol Vascular Diseases Trace Elements Bone Density Conservation Agents Cardiovascular Agents Calcitriol |
Calcium, Dietary Vitamin D Vitamins Vasoconstrictor Agents Micronutrients Hypertension |
|
Molecular Mechanisms of Pharmacological Action Growth Substances Physiological Effects of Drugs Calcium Channel Agonists Vascular Diseases Bone Density Conservation Agents Cardiovascular Agents Pharmacologic Actions Calcitriol |
Membrane Transport Modulators Vitamin D Therapeutic Uses Vitamins Vasoconstrictor Agents Cardiovascular Diseases Micronutrients Hypertension |
