Vitamin D, Blood Pressure, Lipids, Infection and Depression

University of Tromso (UiT)

Status and phase: Completed; Phase 3

Conditions: Hypovitaminosis D

Treatments: Drug: placebo; Drug: Cholecalciferol

Study type: Interventional

Funder types: Other

Identifiers

NCT00960232

UIT-ENDO-2009-1

Details and patient eligibility

About

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.

Enrollment: 250 patients

Sex: All

Ages: 30 to 75 years old

Volunteers: Accepts 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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250 participants in 2 patient groups, including a placebo group

Vitamin D

Experimental group

Description:

vitamin D 40.000 IU per weel

Treatment:

Drug: Cholecalciferol

Placebo

Placebo Comparator group

Description:

Placebo

Treatment:

Drug: placebo