Effect of Vitamin D Replacement During Winter Months in P... | NCT01166165

Studies
Effect of Vitamin D Replacement During Winter Months in Patients With Hypertension

NCT01166165

Sponsor

Regional Hospital Holstebro

Status

Completed

Last Update Posted

Jun 19, 2012Estimated

Enrollment

136Actual

Phase

Phase 2

Conditions

Hypertension
Vitamin D Deficiency

Interventions

Cholecalciferol
Placebo

Countries

Denmark

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
M-20100120	Other Identifier	The Regional Committee on Biomedical Research Ethics

Status Module

Record Verification Date

Jun 2012

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jul 2010

Primary Completion Date

Apr 2011Actual

Completion Date

Apr 2011Actual

First Submitted Date

Jul 19, 2010

First Submission Date that Met QC Criteria

Jul 19, 2010

First Posted Date

Jul 20, 2010Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jun 18, 2012

Last Update Posted Date

Jun 19, 2012Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

136Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Cholecalciferol	Active Comparator		Drug: Cholecalciferol
Placebo	Placebo Comparator		Drug: Placebo

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Cholecalciferol	Drug	3 tablets of 1000 IU daily for 20 weeks	Cholecalciferol

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
24-hour systolic blood pressure		20 weeks

Secondary Outcomes

Measure	Description	Time Frame
Plasma renin concentration		20 weeks
Plasma concentration of angiotensin II		20 weeks
Plasma concentration of aldosterone

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Well-regulated arterial hypertension
Office blood pressure > 120/70 mmHg

Exclusion Criteria:

Pregnancy or nursing
Cancer
Alcohol abuse
Continuous glucocorticoid or NSAID treatment
24-hour blood pressure > 150/95 mmHg
Hypercalcemia

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Thomas Larsen, M.D.	Departments of Medical Research, Holstebro Hospital	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Department of Medical Research		Holstebro	Holstebro	7500	Denmark

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
22854639	Derived	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.

ID	Term
D014652	Vascular Diseases
D002318	Cardiovascular Diseases
D001361	Avitaminosis
D003677	Deficiency Diseases

ID	Term
D002782	Cholestenes
D002776	Cholestanes
D013256	Steroids
D000072473	Fused-Ring Compounds

ID	Term
D006973	Hypertension
D014808	Vitamin D Deficiency