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NCT00960232 Clinical Trial

Vitamin D, Blood Pressure, Lipids, Infection and Depression

Hypovitaminosis D Clinical Trial

Official title:
Vitamin D, Blood Pressure, Lipids, Infection and Depression

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00960232
Other study ID # UIT-ENDO-2009-1
Secondary ID
Status Completed
Phase Phase 3
First received August 14, 2009
Last updated September 3, 2012
Start date September 2009
Est. completion date December 2010

Study information
Verified date September 2012
Source University of Tromso
Contact n/a
Is FDA regulated No
Health authority Norway: Norwegian Medicines Agency
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 250
Est. completion date December 2010
Est. primary completion date December 2010
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 30 Years to 75 Years
Eligibility Inclusion Criteria:

- men and women 30 - 75 years of age

- low serum 25(OH)D levels

Exclusion Criteria:

- diabetes

- other serious diseases

- hypercalcemia

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Drug:
• Cholecalciferol
40.000 IU cholecalciferol per week for 6 months
• placebo
placebo

Locations
Country Name City State
Norway University of Tromsø Tromsø

Sponsors (1)
Lead Sponsor Collaborator
University of Tromso

Country where clinical trial is conducted

Norway, 

Outcome
Type Measure Description Time frame Safety issue
Primary Depression score 6 months No
Primary Blood pressure 6 months No
Primary Lipid profile 6 months No
Primary Frequency of infections 6 months No
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