Hypovitaminosis D Clinical Trial
Official title:
Vitamin D, Blood Pressure, Lipids, Infection and Depression
Verified date | September 2012 |
Source | University of Tromso |
Contact | n/a |
Is FDA regulated | No |
Health authority | Norway: Norwegian Medicines Agency |
Study type | Interventional |
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.
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 |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Norway | University of Tromsø | Tromsø |
Lead Sponsor | Collaborator |
---|---|
University of Tromso |
Norway,
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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