Effect of Vitamin D Replacement During Winter Months in Patients With Hypertension
Effect of Cholecalciferol on 24-hr ABPM and Vasoactive Hormones in Patients With Hypertension.
2 other identifiers
interventional
136
1 country
1
Brief Summary
High blood pressure is related to increased risk of cardiovascular disease and death, and accounts for approximately 8 mill deaths worldwide each year. Blood pressure exhibits a seasonal variation with a tendency to increase during winter months. Vitamin D deficiency is more common during months where UVB radiation from the sun is absent, and vitamin D has been associated with high blood pressure. This study will evaluate the effect of vitamin D replacement during winter months on blood pressure and vasoactive hormones in patients with high blood pressure.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2 hypertension
Started Jul 2010
Shorter than P25 for phase_2 hypertension
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 1, 2010
CompletedFirst Submitted
Initial submission to the registry
July 19, 2010
CompletedFirst Posted
Study publicly available on registry
July 20, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2011
CompletedJune 19, 2012
June 1, 2012
9 months
July 19, 2010
June 18, 2012
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
24-hour systolic blood pressure
20 weeks
Secondary Outcomes (13)
Plasma renin concentration
20 weeks
Plasma concentration of angiotensin II
20 weeks
Plasma concentration of aldosterone
20 weeks
Plasma concentration of c-reactive protein
20 weeks
Urine albumin creatinine ratio
20 weeks
- +8 more secondary outcomes
Study Arms (2)
Cholecalciferol
ACTIVE COMPARATORPlacebo
PLACEBO COMPARATORInterventions
Eligibility Criteria
You may qualify if:
- Well-regulated arterial hypertension
- Office blood pressure \> 120/70 mmHg
You may not qualify if:
- Pregnancy or nursing
- Cancer
- Alcohol abuse
- Continuous glucocorticoid or NSAID treatment
- hour blood pressure \> 150/95 mmHg
- Hypercalcemia
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Department of Medical Research
Holstebro, Holstebro, 7500, Denmark
Related Publications (1)
Larsen T, Mose FH, Bech JN, Hansen AB, Pedersen EB. Effect of cholecalciferol supplementation during winter months in patients with hypertension: a randomized, placebo-controlled trial. Am J Hypertens. 2012 Nov;25(11):1215-22. doi: 10.1038/ajh.2012.111. Epub 2012 Aug 2.
PMID: 22854639DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Thomas Larsen, M.D.
Departments of Medical Research, Holstebro Hospital
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- DMSci
Study Record Dates
First Submitted
July 19, 2010
First Posted
July 20, 2010
Study Start
July 1, 2010
Primary Completion
April 1, 2011
Study Completion
April 1, 2011
Last Updated
June 19, 2012
Record last verified: 2012-06