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Vitamin D, Blood Pressure, Lipids, Infection and Depression

Primary Purpose

Hypovitaminosis D

Status
Completed
Phase
Phase 3
Locations
Norway
Study Type
Interventional
Intervention
Cholecalciferol
placebo
Sponsored by
University of Tromso
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hypovitaminosis D focused on measuring vitamin D, blood pressure, lipids, infection, depression

Eligibility Criteria

30 Years - 75 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • men and women 30 - 75 years of age
  • low serum 25(OH)D levels

Exclusion Criteria:

  • diabetes
  • other serious diseases
  • hypercalcemia

Sites / Locations

  • University of Tromsø

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Vitamin D

Placebo

Arm Description

vitamin D 40.000 IU per weel

Placebo

Outcomes

Primary Outcome Measures

Depression score
Blood pressure
Lipid profile
Frequency of infections

Secondary Outcome Measures

Full Information

First Posted
August 14, 2009
Last Updated
September 3, 2012
Sponsor
University of Tromso
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1. Study Identification

Unique Protocol Identification Number
NCT00960232
Brief Title
Vitamin D, Blood Pressure, Lipids, Infection and Depression
Official Title
Vitamin D, Blood Pressure, Lipids, Infection and Depression
Study Type
Interventional

2. Study Status

Record Verification Date
September 2012
Overall Recruitment Status
Completed
Study Start Date
September 2009 (undefined)
Primary Completion Date
December 2010 (Actual)
Study Completion Date
December 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Tromso

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
There are numerous indications for a relation between low serum levels of 25(OH)D and blood pressure, lipid levels, frequency of infections and tendency towards depression. Whether it is a causal relationship it is not known, and can best be studied with a vitamin D intervention. The investigators hypothesis is that supplementation with a high dose vitamin D (40.000 IU per week) will have a beneficial effect on these parameters.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypovitaminosis D
Keywords
vitamin D, blood pressure, lipids, infection, depression

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
250 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Vitamin D
Arm Type
Experimental
Arm Description
vitamin D 40.000 IU per weel
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo
Intervention Type
Drug
Intervention Name(s)
Cholecalciferol
Other Intervention Name(s)
Decristol
Intervention Description
40.000 IU cholecalciferol per week for 6 months
Intervention Type
Drug
Intervention Name(s)
placebo
Intervention Description
placebo
Primary Outcome Measure Information:
Title
Depression score
Time Frame
6 months
Title
Blood pressure
Time Frame
6 months
Title
Lipid profile
Time Frame
6 months
Title
Frequency of infections
Time Frame
6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: men and women 30 - 75 years of age low serum 25(OH)D levels Exclusion Criteria: diabetes other serious diseases hypercalcemia
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Rolf Jorde, Professor
Organizational Affiliation
University of Tromso
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Tromsø
City
Tromsø
ZIP/Postal Code
9037
Country
Norway

12. IPD Sharing Statement

Citations:
PubMed Identifier
22790678
Citation
Kjaergaard M, Waterloo K, Wang CE, Almas B, Figenschau Y, Hutchinson MS, Svartberg J, Jorde R. Effect of vitamin D supplement on depression scores in people with low levels of serum 25-hydroxyvitamin D: nested case-control study and randomised clinical trial. Br J Psychiatry. 2012 Nov;201(5):360-8. doi: 10.1192/bjp.bp.111.104349. Epub 2012 Jul 12.
Results Reference
derived

Learn more about this trial

Vitamin D, Blood Pressure, Lipids, Infection and Depression

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