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Nutritional Problems After Lung and Heart Transplantation

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified January 2009 by Oslo University Hospital.
Recruitment status was:  Active, not recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT00826254
First Posted: January 22, 2009
Last Update Posted: July 6, 2011
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Norwegian Foundation for Health and Rehabilitation
Information provided by:
Oslo University Hospital
  Purpose

Part 1) Bone health after transplantation - possible influence of vitamin K

Part 2) Fat metabolism and endocrine parameters - possible predictors for developement of overweight after transplantation


Condition Intervention
Bone Density Overweight Drug: Vitamin K

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Nutritional Problems After Lung and Heart Transplantation

Resource links provided by NLM:


Further study details as provided by Oslo University Hospital:

Primary Outcome Measures:
  • plasma vitamin K [ Time Frame: 1 year ]

Secondary Outcome Measures:
  • Bone mineral density [ Time Frame: 1 year ]

Enrollment: 94
Study Start Date: August 2003
Estimated Study Completion Date: December 2011
Primary Completion Date: April 2007 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: Vitamin K
    180 micrograms vitamin K daily
    Other Name: Natto
    Drug: Vitamin K

    2 capsules daily 180 micrograms vitamin K daily or placebo

    1 year

    Other Name: Natto
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • accepted for transplantation

Exclusion Criteria:

  • not accepted for transplantation
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00826254


Locations
Norway
Rikshospitalet HF
Oslo, Norway
Sponsors and Collaborators
Oslo University Hospital
Norwegian Foundation for Health and Rehabilitation
Investigators
Principal Investigator: Liv Forli, Dr Oslo University Hospital
Study Director: Liv Forli, Dr Oslo University Hospital
Study Chair: Oystein Bjortuft, MD Oslo University Hospital
  More Information

Responsible Party: Liv Forli, Rikshospitalet HF
ClinicalTrials.gov Identifier: NCT00826254     History of Changes
Other Study ID Numbers: S-03124 (REK)
2006/4716 (Personvernombud)
First Submitted: January 21, 2009
First Posted: January 22, 2009
Last Update Posted: July 6, 2011
Last Verified: January 2009

Keywords provided by Oslo University Hospital:
vitamin K
Bone Mineral Density
undercarboxylated osteocalcin

Additional relevant MeSH terms:
Overweight
Nutrition Disorders
Body Weight
Signs and Symptoms
Vitamins
Vitamin K
Micronutrients
Growth Substances
Physiological Effects of Drugs
Antifibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Hemostatics
Coagulants