Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 2 of 184 for:    vitaminD and lipids

Vitamin D, Blood Pressure, Lipids, Infection and Depression

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00960232
Recruitment Status : Completed
First Posted : August 17, 2009
Last Update Posted : September 5, 2012
Sponsor:
Information provided by (Responsible Party):
University of Tromso

Tracking Information
First Submitted Date  ICMJE August 14, 2009
First Posted Date  ICMJE August 17, 2009
Last Update Posted Date September 5, 2012
Study Start Date  ICMJE September 2009
Actual Primary Completion Date December 2010   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 14, 2009)
  • Depression score [ Time Frame: 6 months ]
  • Blood pressure [ Time Frame: 6 months ]
  • Lipid profile [ Time Frame: 6 months ]
  • Frequency of infections [ Time Frame: 6 months ]
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT00960232 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Vitamin D, Blood Pressure, Lipids, Infection and Depression
Official Title  ICMJE Vitamin D, Blood Pressure, Lipids, Infection and Depression
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Hypovitaminosis D
Intervention  ICMJE
  • Drug: Cholecalciferol
    40.000 IU cholecalciferol per week for 6 months
    Other Name: Decristol
  • Drug: placebo
    placebo
Study Arms  ICMJE
  • Experimental: Vitamin D
    vitamin D 40.000 IU per weel
    Intervention: Drug: Cholecalciferol
  • Placebo Comparator: Placebo
    Placebo
    Intervention: Drug: placebo
Publications * Kjærgaard M, Waterloo K, Wang CE, Almås 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: August 14, 2009)
250
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE December 2010
Actual Primary Completion Date December 2010   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

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

Exclusion Criteria:

  • diabetes
  • other serious diseases
  • hypercalcemia
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 30 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Norway
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00960232
Other Study ID Numbers  ICMJE UIT-ENDO-2009-1
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party University of Tromso
Study Sponsor  ICMJE University of Tromso
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Rolf Jorde, Professor University of Tromso
PRS Account University of Tromso
Verification Date September 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP