Perimenopausal Bone LossPhase 2NCT00290212
Natto Supplementation to Prevent Loss of Bone Mass in Women Immediately After Menopause
A Phase 2 study testing Natto capsules (food suppl.) cont. 360 microg. vit K2/day in people with Perimenopausal Bone Loss, run by University Hospital of North Norway at 2 sites in Norway.
Trial summary
Study Objective: To determine whether Natto supplementation in women immediately after menopause might prevent severe bone loss Study population: Women 50 - 60 years, 1-5 years after menopause Study Design: Double-blind, placebo-controlled, randomized controlled trial. A "phase II" clinical trial. Read more about this study
- Who is it for?
- Ages 50 to 60 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Perimenopausal Bone Loss
- What is being tested?
- Natto capsules (food suppl.) cont. 360 microg. vit K2/day
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 304 participants
- Where
- 2 sitesNorway
- Study dates
- Jan 2006to Jun 2007
- Phase
- Phase 2
- 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 50 to 60 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Women living in the city of Tromsø, not using hormone replacement therapy, 1-5 years after menopause.
Who cannot join
- History of hip fracture
- Bone disease affecting bone mineral density
- Use of vitamin K antagonists
- Significant co-morbidity that makes it difficult to obtain BMD measurements
- Use of hormone replacement therapy or other therapy that influence bone remodeling
Trial locations and contacts
2 sites in 1 country.
Norway2 sites
Haukeland University Hospital
Bergen, NO 5021
Clinical Research Center, University Hospital of North Norway
Tromsø, Tromsø, N-9038
About this study
Official title: Phase II Study of Natto Supplementation to Prevent Loss of Bone Mass in Women Immediately After Menopause: a Randomised Double Blind Placebo-Controlled Trial
Study Objective: To determine whether Natto supplementation in women immediately after menopause might prevent severe bone loss
Study population: Women 50 - 60 years, 1-5 years after menopause
Read more
Study Design: Double-blind, placebo-controlled, randomized controlled trial. A "phase II" clinical trial.
Instruments Used to Measure Therapeutic Response: Lunar Prodigy DEXA bone densitometer
Study Treatment Group: Daily supplementation with Vitamin K2, "NATTO"
Study Control Group: Identically-looking placebo medication
Duration of treatment: 12 months
Duration of Subject Participation in Study: 12 months Assessment of Therapeutic response: Given an expected reduction of bone mass density of - 1.1% annually in the placebo group, the minimum clinically significant difference between the groups is 0.3 percentage points. The trial is therefore powered to detect a reduction in annual bone mass loss of 0.3 percentage points in the treatment group.
Numbers of Evaluable Subjects Required: 304 Maximum # Subjects 334
- Conditions
- Perimenopausal Bone Loss
- Being tested
- Natto capsules (food suppl.) cont. 360 microg. vit K2/day, Placebo capsules
- Keywords
- Women, Bone density, Menopause, Dietary Supplements, Vitamin K2
- Medical subject headings
- Osteoporosis, Postmenopausal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Natto capsules (food suppl.) cont. 360 microg. vit K2/dayDrug
Placebo capsulesDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Bone mass density
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Feb 2006 (estimated)
- Study startJan 2006
- Study completionJun 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Perimenopausal Bone LossStudies of the same condition, open and under way.
- 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 2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 304 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital of North Norway
- Sponsor type
- University, hospital or other
- Collaborators
- University of Tromso, The International Osteoporosis Foundation, Haukeland University Hospital
- Investigators
- Nina Emaus, MSc PhD, Principal investigator, NAFKAM, Fac.of Medicine, Univ. of Tromsø, NorwaySameline Grimsgaard, MD, MPH, PhD, Principal investigator, University Hospital of North NorwayVinjar Fønnebø, MD, MSc, PhD, Study chair, NAFKAM, University of Tromsø, Norway
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00290212
- Sponsor's protocol ID
- REK V 77/2005
- Status last verified
- Dec 2006
- First submitted
- 9 Feb 2006
- Last updated
- 24 Jan 2008
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Jan 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II Study of Natto Supplementation to Prevent Loss of Bone Mass in Women Immediately After Menopause: a Randomised Double Blind Placebo-Controlled Trial
- ClinicalTrials.gov ID
- NCT00290212
- Acronym / sponsor ID
- REK V 77/2005
- Conditions
- Perimenopausal Bone Loss
- Keywords
- Women, Bone density, Menopause, Dietary Supplements, Vitamin K2
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 304 participants (actual)
- Lead sponsor
- University Hospital of North NorwayUniversity, hospital or other
- Collaborators
- University of Tromso, The International Osteoporosis Foundation, Haukeland University Hospital
- Study start
- Jan 2006
- Study completion
- Jun 2007
- First posted
- 10 Feb 2006 (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.
Study Objective: To determine whether Natto supplementation in women immediately after menopause might prevent severe bone loss
Study population: Women 50 - 60 years, 1-5 years after menopause
Study Design: Double-blind, placebo-controlled, randomized controlled trial. A "phase II" clinical trial.
Instruments Used to Measure Therapeutic Response: Lunar Prodigy DEXA bone densitometer
Study Treatment Group: Daily supplementation with Vitamin K2, "NATTO"
Study Control Group: Identically-looking placebo medication
Duration of treatment: 12 months
Duration of Subject Participation in Study: 12 months Assessment of Therapeutic response: Given an expected reduction of bone mass density of - 1.1% annually in the placebo group, the minimum clinically significant difference between the groups is 0.3 percentage points. The trial is therefore powered to detect a reduction in annual bone mass loss of 0.3 percentage points in the treatment group.
Numbers of Evaluable Subjects Required: 304 Maximum # Subjects 334
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
Who may qualify
- Ages
- 50 to 60 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Women living in the city of Tromsø, not using hormone replacement therapy, 1-5 years after menopause.
Key exclusion criteria (5 listed)
- History of hip fracture
- Bone disease affecting bone mineral density
- Use of vitamin K antagonists
- Significant co-morbidity that makes it difficult to obtain BMD measurements
- Use of hormone replacement therapy or other therapy that influence bone remodeling
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 |
|---|---|---|
| Natto capsules (food suppl.) cont. 360 microg. vit K2/day | Drug | – |
| Placebo capsules | Drug | – |
Primary outcome
Bone mass density
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jan 2008.
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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.
Nina Emaus, MSc PhD principal investigator
NAFKAM, Fac.of Medicine, Univ. of Tromsø, Norway
Sameline Grimsgaard, MD, MPH, PhD principal investigator
University Hospital of North Norway
Vinjar Fønnebø, MD, MSc, PhD study chair
NAFKAM, University of Tromsø, Norway
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Natto capsules (food suppl.) cont. 360 microg. vit K2/day in people with Perimenopausal Bone Loss, run by University Hospital of North Norway at 2 sites 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 5 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: finished, as of the sponsor's last update on 24 Jan 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Bone mass density. 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 24 Jan 2008.