Vitamin D, Blood Pressure, Lipids, Infection and Depression

Phase 3

Completed

• Conditions: Hypovitaminosis D
• Interventions: Drug: Cholecalciferol; Drug: placebo

• Registration Number: NCT00960232
• Lead Sponsor: University of Tromso

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 available

Study Timeline

• Study First Submitted: 2009-08-14
• Study First Submitted QC: 2009-08-14
• Study First Posted: 2009-08-17
• Study Start: 2009-09
• Primary Completion: 2010-12
• Study Completion: 2010-12
• Status Verified: 2012-09
• Last Update Submitted: 2012-09-03
• Last Update Posted: 2012-09-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 250

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Vitamin D	Cholecalciferol	vitamin D 40.000 IU per weel
Placebo	placebo	Placebo

Primary Outcome Measures

Name	Time	Method
Depression score	6 months
Blood pressure	6 months
Lipid profile	6 months
Frequency of infections	6 months

Trial Locations

Locations (1)

University of Tromsø; 🇳🇴 Tromsø, Norway