NCT00497900

Brief Summary

Previous studies have shown high proportions of vitamin D deficiency among elderly in Denmark. Vitamin D is important for muscular function. The investigators intend to examine if it is possible to improve cardiovascular function in patients with heart failure and vitamin D deficiency by supplementation with vitamin D.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
45

participants targeted

Target at P25-P50 for phase_4 heart-failure

Timeline
Completed

Started Aug 2007

Longer than P75 for phase_4 heart-failure

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

July 6, 2007

Completed
3 days until next milestone

First Posted

Study publicly available on registry

July 9, 2007

Completed
23 days until next milestone

Study Start

First participant enrolled

August 1, 2007

Completed
4.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2011

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2011

Completed
Last Updated

June 3, 2015

Status Verified

March 1, 2012

Enrollment Period

4.1 years

First QC Date

July 6, 2007

Last Update Submit

June 2, 2015

Conditions

Heart FailureVitamin D Deficiency

Outcome Measures

Primary Outcomes (1)

  • Ejection fraction

    6 months

Secondary Outcomes (3)

  • 6 minutes walk test

    6 months

  • Quality of life

    6 months

  • Biochemical markers

    6 months

Study Arms (2)

1

EXPERIMENTAL

Calcium and vitamin D

Drug: Vitamin D

2

PLACEBO COMPARATOR

Calcium and placebo (cellulose)

Drug: Vitamin D

Interventions

Vitamin DDRUG

Daily vitamin D (cholecalciferol) tablets and rocaltrol

12

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Over 18 years of age
  • Vitamin D (serum 25-OHD): 50nmol/l or less
  • Heart failure (EF 40% or less, NYHA:2 or more)

You may not qualify if:

  • Calcium metabolic disturbances
  • Granulomatous diseases
  • Alcohol or drug abuse
  • Intake of 400IU (or more) vitamin D/day
  • Condition too poor to participate
  • Pregnancy
  • AF with HF 90 or above
  • Mitral insufficiency, degree 3 or above
  • Large cardiac aneurisms
  • Significant aorta stenosis
  • Significant aorta insufficiency
  • Allergy to components

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hvidovre University Hospital

Hvidovre, 2650, Denmark

Location

Related Publications (5)

  • Nielsen OW, Raymond IE, Kirk V, Pedersen F, Bay-Nielsen M. [The epidemiology of heart failure from a Danish perspective]. Ugeskr Laeger. 2004 Jan 19;166(4):243-7. No abstract available. Danish.

    PMID: 14964101BACKGROUND

  • Holick MF. The vitamin D epidemic and its health consequences. J Nutr. 2005 Nov;135(11):2739S-48S. doi: 10.1093/jn/135.11.2739S.

    PMID: 16251641BACKGROUND

  • O'Connell TD, Simpson RU. Immunochemical identification of the 1,25-dihydroxyvitamin D3 receptor protein in human heart. Cell Biol Int. 1996 Sep;20(9):621-4. doi: 10.1006/cbir.1996.0081.

    PMID: 8948124BACKGROUND

  • Pepe J, Romagnoli E, Nofroni I, Pacitti MT, De Geronimo S, Letizia C, Tonnarini G, Scarpiello A, D'Erasmo E, Minisola S. Vitamin D status as the major factor determining the circulating levels of parathyroid hormone: a study in normal subjects. Osteoporos Int. 2005 Jul;16(7):805-12. doi: 10.1007/s00198-004-1757-4. Epub 2004 Nov 16.

    PMID: 15551058BACKGROUND

  • Horl WH. The clinical consequences of secondary hyperparathyroidism: focus on clinical outcomes. Nephrol Dial Transplant. 2004 Aug;19 Suppl 5:V2-8. doi: 10.1093/ndt/gfh1049.

    PMID: 15284353BACKGROUND

MeSH Terms

Conditions

Heart FailureVitamin D Deficiency

Interventions

Vitamin D

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular DiseasesAvitaminosisDeficiency DiseasesMalnutritionNutrition DisordersNutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

SecosteroidsSteroidsFused-Ring CompoundsPolycyclic Compounds

Study Officials

  • Jens-Erik B Jensen, MD, PhD

    Hvidovre University Hospital

    STUDY DIRECTOR

  • Louise Lind Schierbeck, MD

    Hvidovre University Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD, research fellow

Study Record Dates

First Submitted

July 6, 2007

First Posted

July 9, 2007

Study Start

August 1, 2007

Primary Completion

September 1, 2011

Study Completion

December 1, 2011

Last Updated

June 3, 2015

Record last verified: 2012-03

Locations

DK(1)