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Vitamin D, Blood Pressure, Lipids, Infection and Depression

NCT ID: NCT00960232

Last Updated: 2012-09-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

250 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-09-30

Study Completion Date

2010-12-31

Brief Summary

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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

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Conditions

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Hypovitaminosis D

Keywords

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vitamin D blood pressure lipids infection depression

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Vitamin D

vitamin D 40.000 IU per weel

Group Type EXPERIMENTAL

Cholecalciferol

Intervention Type DRUG

40.000 IU cholecalciferol per week for 6 months

Placebo

Placebo

Group Type PLACEBO_COMPARATOR

placebo

Intervention Type DRUG

placebo

Interventions

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Cholecalciferol

40.000 IU cholecalciferol per week for 6 months

Intervention Type DRUG

placebo

placebo

Intervention Type DRUG

Other Intervention Names

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Decristol

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* diabetes
* other serious diseases
* hypercalcemia
Minimum Eligible Age

30 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University of Tromso

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Rolf Jorde, Professor

Role: PRINCIPAL_INVESTIGATOR

University of Tromso

Locations

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University of Tromsø

Tromsø, Tromsø, Norway

Site Status

Countries

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Norway

References

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Kjaergaard M, Waterloo K, Wang CE, Almas 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.

Reference Type DERIVED
PMID: 22790678 (View on PubMed)

Other Identifiers

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UIT-ENDO-2009-1

Identifier Type: -

Identifier Source: org_study_id