Bone DensityNCT00826254
Nutritional Problems After Lung and Heart Transplantation
A study testing Vitamin K in people with Bone Density and Overweight, run by Oslo University Hospital at 1 site in Norway.
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 Read more about this study
- Who is it for?
- Ages 20 to 70 years
- Conditions the study is for
- Bone Density, Overweight
- What is being tested?
- Vitamin K
- Type of treatment
- Pill or oral medicine
- How many people
- 94 participants
- Where
- 1 siteNorway
- Study dates
- Aug 2003to Dec 2011
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- accepted for transplantation
Who cannot join
- not accepted for transplantation
Trial locations and contacts
1 site in 1 country.
About this study
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
- Conditions
- Bone Density, Overweight
- Being tested
- Vitamin K
- Keywords
- vitamin K, Bone Mineral Density, undercarboxylated osteocalcin
- Medical subject headings
- Overweight
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vitamin KDrug
Also called Natto
180 micrograms vitamin K daily
Vitamin KDrug
Also called Natto
2 capsules daily 180 micrograms vitamin K daily or placebo
1 year
What is being measured
The primary outcome is the main question the study is designed to answer.
plasma vitamin K
Measured: 1 year
Secondary outcomes (1)
Bone mineral density
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jan 2009 (estimated)
- Study startAug 2003
- Primary completionApr 2007
- Study completionDec 2011 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bone DensityStudies of the same condition, open and under way.
- More trials run by Oslo University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 94 participants (actual)
Sponsor and investigators
- Lead sponsor
- Oslo University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Norwegian Foundation for Health and Rehabilitation
- Investigators
- Liv Forli, Dr, Principal investigator, Oslo University HospitalLiv Forli, Dr, Study director, Oslo University HospitalOystein Bjortuft, MD, Study chair, Oslo University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00826254
- Sponsor's protocol ID
- S-03124 (REK)
- Other IDs
- 2006/4716 (Personvernombud)
- Status last verified
- Jan 2009
- First submitted
- 21 Jan 2009
- Last updated
- 6 Jul 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Jul 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Nutritional Problems After Lung and Heart Transplantation
- ClinicalTrials.gov ID
- NCT00826254
- Acronym / sponsor ID
- S-03124 (REK)
- Conditions
- Bone Density, Overweight
- Keywords
- vitamin K, Bone Mineral Density, undercarboxylated osteocalcin
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 94 participants (actual)
- Lead sponsor
- Oslo University HospitalUniversity, hospital or other
- Collaborators
- Norwegian Foundation for Health and Rehabilitation
- Study start
- Aug 2003
- Primary completion
- Apr 2007 (actual)
- Study completion
- Dec 2011 (estimated)
- First posted
- 22 Jan 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
Who may qualify
- Ages
- 20 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- accepted for transplantation
Key exclusion criteria (1 listed)
- not accepted for transplantation
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Vitamin KAlso: Natto180 micrograms vitamin K daily | Drug | – |
| Vitamin KAlso: Natto2 capsules daily 180 micrograms vitamin K daily or placebo 1 year | Drug | – |
Primary outcome
plasma vitamin K
Time frame: 1 year
1 secondary outcome
Bone mineral density
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jul 2011.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Liv Forli, Dr principal investigator
Oslo University Hospital
Liv Forli, Dr study director
Oslo University Hospital
Oystein Bjortuft, MD study chair
Oslo University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Vitamin K in people with Bone Density and Overweight, run by Oslo University Hospital at 1 site in Norway.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 6 Jul 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Norway. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
plasma vitamin K (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Jul 2011.