Nutritional Problems After Lung and Heart Transplantation

The recruitment status of this study is unknown because the information has not been verified recently.
Verified January 2009 by Oslo University Hospital.
Recruitment status was  Active, not recruiting
Sponsor:
Collaborator:
Norwegian Foundation for Health and Rehabilitation
Information provided by:
Oslo University Hospital
ClinicalTrials.gov Identifier:
NCT00826254
First received: January 21, 2009
Last updated: July 3, 2011
Last verified: January 2009
  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
Endpoint Classification: Bio-equivalence Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Bone mineral density [ Time Frame: 1 year ] [ Designated as safety issue: No ]

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

Ages Eligible for Study:   20 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • accepted for transplantation

Exclusion Criteria:

  • not accepted for transplantation
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: Liv Forli, Rikshospitalet HF
ClinicalTrials.gov Identifier: NCT00826254     History of Changes
Other Study ID Numbers: S-03124 (REK), 2006/4716 (Personvernombud)
Study First Received: January 21, 2009
Last Updated: July 3, 2011
Health Authority: Norway:National Committee for Medical and Health Research Ethics
Norway: Norwegian Social Science Data Services

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

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

ClinicalTrials.gov processed this record on October 29, 2014