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Nutritional Problems After Lung and Heart Transplantation

This study is ongoing, but not recruiting participants.
Norwegian Foundation for Health and Rehabilitation
Information provided by:
Oslo University Hospital Identifier:
First received: January 21, 2009
Last updated: July 3, 2011
Last verified: January 2009

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
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

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

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 identifier: NCT00826254

Rikshospitalet HF
Oslo, Norway
Sponsors and Collaborators
Oslo University Hospital
Norwegian Foundation for Health and Rehabilitation
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 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:
Nutrition Disorders
Body Weight
Signs and Symptoms
Vitamin K
Growth Substances
Physiological Effects of Drugs
Antifibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Coagulants processed this record on January 18, 2017