Nutritional Problems After Lung and Heart Transplantation | NCT00826254

Studies
Nutritional Problems After Lung and Heart Transplantation

NCT00826254

Sponsor

Oslo University Hospital

Status

Unknown status

Last Update Posted

Jul 6, 2011Estimated

Enrollment

94Actual

Phase

Not Applicable

Conditions

Bone Density
Overweight

Interventions

Vitamin K
Vitamin K

Countries

Norway

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
2006/4716 (Personvernombud)

Status Module

Record Verification Date

Jan 2009

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Active, not recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Aug 2003

Primary Completion Date

Apr 2007Actual

Completion Date

Dec 2011Estimated

First Submitted Date

Jan 21, 2009

First Submission Date that Met QC Criteria

Jan 21, 2009

First Posted Date

Jan 22, 2009Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 3, 2011

Last Update Posted Date

Jul 6, 2011Estimated

Name	Class
Norwegian Foundation for Health and Rehabilitation	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

94Actual

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Vitamin K	Drug	180 micrograms vitamin K daily		Natto
Vitamin K	Drug	2 capsules daily 180 micrograms vitamin K daily or placebo 1 year		Natto

Measure	Description	Time Frame
plasma vitamin K		1 year

Measure	Description	Time Frame
Bone mineral density		1 year

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

accepted for transplantation

Exclusion Criteria:

not accepted for transplantation

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

20 Years

Maximum Age

70 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Liv Forli, Dr	Oslo University Hospital	Principal Investigator
Liv Forli, Dr	Oslo University Hospital	Study Director
Oystein Bjortuft, MD	Oslo University Hospital	Study Chair

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Rikshospitalet HF		Oslo	Oslo		Norway

Condition Browse Module

MeSH Terms

ID	Term
D050177	Overweight

Ancestor Terms

ID	Term
D044343	Overnutrition
D009748	Nutrition Disorders
D009750	Nutritional and Metabolic Diseases
D001835	Body Weight

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D014812	Vitamin K
D045730	Soy Foods

Ancestor Terms

ID	Term
D009285	Naphthoquinones
D009281	Naphthalenes
D011084	Polycyclic Aromatic Hydrocarbons
D006841	Hydrocarbons, Aromatic

Browse Leaves

Not provided

Browse Branches

Not provided