NCT00960232

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
250

participants targeted

Target at P50-P75 for phase_3

Timeline
Completed

Started Sep 2009

Shorter than P25 for phase_3

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 14, 2009

Completed
3 days until next milestone

First Posted

Study publicly available on registry

August 17, 2009

Completed
15 days until next milestone

Study Start

First participant enrolled

September 1, 2009

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2010

Completed
Last Updated

September 5, 2012

Status Verified

September 1, 2012

Enrollment Period

1.2 years

First QC Date

August 14, 2009

Last Update Submit

September 3, 2012

Conditions

Hypovitaminosis D

Keywords

vitamin Dblood pressurelipidsinfectiondepression

Outcome Measures

Primary Outcomes (4)

  • Depression score

    6 months

  • Blood pressure

    6 months

  • Lipid profile

    6 months

  • Frequency of infections

    6 months

Study Arms (2)

Vitamin D

EXPERIMENTAL

vitamin D 40.000 IU per weel

Drug: Cholecalciferol

Placebo

PLACEBO COMPARATOR

Placebo

Drug: placebo

Interventions

CholecalciferolDRUG

40.000 IU cholecalciferol per week for 6 months

Also known as: Decristol
Vitamin D
placeboDRUG

placebo

Placebo

Eligibility Criteria

Age30 Years - 75 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • diabetes
  • other serious diseases
  • hypercalcemia

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Tromsø

Tromsø, Tromsø, 9037, Norway

Location

Related Publications (1)

  • 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.

    PMID: 22790678DERIVED

MeSH Terms

Conditions

Vitamin D DeficiencyInfectionsDepression

Interventions

Cholecalciferol

Condition Hierarchy (Ancestors)

AvitaminosisDeficiency DiseasesMalnutritionNutrition DisordersNutritional and Metabolic DiseasesBehavioral SymptomsBehavior

Intervention Hierarchy (Ancestors)

CholestenesCholestanesSteroidsFused-Ring CompoundsPolycyclic CompoundsSterolsVitamin DSecosteroidsMembrane LipidsLipids

Study Officials

  • Rolf Jorde, Professor

    University of Tromso

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 14, 2009

First Posted

August 17, 2009

Study Start

September 1, 2009

Primary Completion

December 1, 2010

Study Completion

December 1, 2010

Last Updated

September 5, 2012

Record last verified: 2012-09

Locations

NO(1)