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Sponsors and Collaborators: |
University Hospital of North Norway University of Tromso Norwegian Osteoporosis Society Haukeland University Hospital |
Information provided by: | University Hospital of North Norway |
ClinicalTrials.gov Identifier: | NCT00290212 |
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
Condition | Intervention | Phase |
Perimenopausal Bone Loss |
Drug: Natto capsules (food suppl.) cont. 360 microg. vit K2/day Drug: Placebo capsules |
Phase II |
MedlinePlus related topics: | Menopause |
Drug Information available for: | Vitamin K |
Study Type: | Interventional |
Study Design: | Prevention, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Efficacy 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 |
Ages Eligible for Study: | 50 Years to 60 Years |
Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
Norway | |||||
Haukeland University Hospital | |||||
Bergen, Norway, NO 5021 | |||||
Clinical Research Center, University Hospital of North Norway | |||||
Tromsø, Norway, N-9038 |
University Hospital of North Norway |
University of Tromso |
Norwegian Osteoporosis Society |
Haukeland University Hospital |
Principal Investigator: | Nina Emaus, MSc PhD | NAFKAM, Fac.of Medicine, Univ. of Tromsø, Norway |
Principal Investigator: | Sameline Grimsgaard, MD, MPH, PhD | University Hospital of North Norway |
Study Chair: | Vinjar Fønnebø, MD, MSc, PhD | NAFKAM, University of Tromsø, Norway |
Study ID Numbers: | REK V 77/2005 |
First Received: | February 9, 2006 |
Last Updated: | January 23, 2008 |
ClinicalTrials.gov Identifier: | NCT00290212 |
Health Authority: | Norway: Norwegian Social Science Data Services |
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