Nutritional Problems After Lung and Heart Transplantation

This study is ongoing, but not recruiting participants.

First Received: January 21, 2009 No Changes Posted

Sponsors and Collaborators:	Rikshospitalet HF Norwegian Foundation for Health and Rehabilitation
Information provided by:	Rikshospitalet HF
ClinicalTrials.gov Identifier:	NCT00826254

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:	Prevention, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Active Control, Parallel Assignment, Bio-equivalence Study
Official Title:	Nutritional Problems After Lung and Heart Transplantation

Resource links provided by NLM:

MedlinePlus related topics: Heart Transplantation Minerals

Drug Information available for: Vitamin K

U.S. FDA Resources

Further study details as provided by Rikshospitalet HF:

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:

180 micrograms vitamin K daily

2 capsules daily 180 micrograms vitamin K daily or placebo

1 year

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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00826254

Locations

Norway
Rikshospitalet HF
Oslo, Norway

Sponsors and Collaborators

Rikshospitalet HF

Norwegian Foundation for Health and Rehabilitation

Investigators

Principal Investigator:	Liv Forli, Dr	Rikshospitalet HF
Study Director:	Liv Forli, Dr	Rikshospitalet HF
Study Chair:	Oystein Bjortuft, MD	Rikshospitalet HF

More Information

No publications provided

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

Keywords provided by Rikshospitalet HF:

vitamin K
Bone Mineral Density
undercarboxylated osteocalcin

Study placed in the following topic categories:

Naphthoquinone
Overweight
Trace Elements
Phylloquinone
Hemostatics
Body Weight
Signs and Symptoms
Antiplasmin

Fibrin Modulating Agents
Antifibrinolytic Agents
Vitamins
Vitamin K
Menadione
Nutrition Disorders
Menaquinone
Micronutrients

Additional relevant MeSH terms:

Molecular Mechanisms of Pharmacological Action
Coagulants
Growth Substances
Physiological Effects of Drugs
Hematologic Agents
Overweight
Pharmacologic Actions
Hemostatics
Body Weight

Signs and Symptoms
Fibrin Modulating Agents
Antifibrinolytic Agents
Therapeutic Uses
Vitamins
Vitamin K
Nutrition Disorders
Micronutrients

ClinicalTrials.gov processed this record on September 11, 2009