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Nutritional Problems After Lung and Heart Transplantation

Primary Purpose

Bone Density, Overweight

Status
Unknown status
Phase
Not Applicable
Locations
Norway
Study Type
Interventional
Intervention
Vitamin K
Vitamin K
Sponsored by
Oslo University Hospital
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional prevention trial for Bone Density focused on measuring vitamin K, Bone Mineral Density, undercarboxylated osteocalcin

Eligibility Criteria

20 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • accepted for transplantation

Exclusion Criteria:

  • not accepted for transplantation

Sites / Locations

  • Rikshospitalet HF

Outcomes

Primary Outcome Measures

plasma vitamin K

Secondary Outcome Measures

Bone mineral density

Full Information

First Posted
January 21, 2009
Last Updated
July 3, 2011
Sponsor
Oslo University Hospital
Collaborators
Norwegian Foundation for Health and Rehabilitation
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1. Study Identification

Unique Protocol Identification Number
NCT00826254
Brief Title
Nutritional Problems After Lung and Heart Transplantation
Official Title
Nutritional Problems After Lung and Heart Transplantation
Study Type
Interventional

2. Study Status

Record Verification Date
January 2009
Overall Recruitment Status
Unknown status
Study Start Date
August 2003 (undefined)
Primary Completion Date
April 2007 (Actual)
Study Completion Date
December 2011 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor
Oslo University Hospital
Collaborators
Norwegian Foundation for Health and Rehabilitation

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bone Density, Overweight
Keywords
vitamin K, Bone Mineral Density, undercarboxylated osteocalcin

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
94 (Actual)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Vitamin K
Other Intervention Name(s)
Natto
Intervention Description
180 micrograms vitamin K daily
Intervention Type
Drug
Intervention Name(s)
Vitamin K
Other Intervention Name(s)
Natto
Intervention Description
2 capsules daily 180 micrograms vitamin K daily or placebo 1 year
Primary Outcome Measure Information:
Title
plasma vitamin K
Time Frame
1 year
Secondary Outcome Measure Information:
Title
Bone mineral density
Time Frame
1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: accepted for transplantation Exclusion Criteria: not accepted for transplantation
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Liv Forli, Dr
Organizational Affiliation
Oslo University Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Liv Forli, Dr
Organizational Affiliation
Oslo University Hospital
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Oystein Bjortuft, MD
Organizational Affiliation
Oslo University Hospital
Official's Role
Study Chair
Facility Information:
Facility Name
Rikshospitalet HF
City
Oslo
Country
Norway

12. IPD Sharing Statement

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Nutritional Problems After Lung and Heart Transplantation

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