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NCT00826254 Clinical Trial

Nutritional Problems After Lung and Heart Transplantation

Overweight Clinical Trial

Official title:
Nutritional Problems After Lung and Heart Transplantation

Clinical Trial Details — Status: Active, not recruiting

Administrative data
NCT number NCT00826254
Other study ID # S-03124 (REK)
Secondary ID 2006/4716 (Perso
Status Active, not recruiting
Phase N/A
First received January 21, 2009
Last updated July 3, 2011
Start date August 2003
Est. completion date December 2011

Study information
Verified date January 2009
Source Oslo University Hospital
Contact n/a
Is FDA regulated No
Health authority Norway:National Committee for Medical and Health Research EthicsNorway: Norwegian Social Science Data Services
Study type Interventional

Clinical Trial 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

Recruitment information / eligibility
Status Active, not recruiting
Enrollment 94
Est. completion date December 2011
Est. primary completion date April 2007
Accepts healthy volunteers No
Gender Both
Age group 20 Years to 70 Years
Eligibility Inclusion Criteria:

- accepted for transplantation

Exclusion Criteria:

- not accepted for transplantation

Study Design

Allocation: Randomized, Endpoint Classification: Bio-equivalence Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

Intervention

Drug:
• Vitamin K
180 micrograms vitamin K daily
• Vitamin K
2 capsules daily 180 micrograms vitamin K daily or placebo 1 year

Locations
Country Name City State
Norway Rikshospitalet HF Oslo

Sponsors (2)
Lead Sponsor Collaborator
Oslo University Hospital Norwegian Foundation for Health and Rehabilitation

Country where clinical trial is conducted

Norway, 

Outcome
Type Measure Description Time frame Safety issue
Primary plasma vitamin K 1 year No
Secondary Bone mineral density 1 year No
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