Natto Supplementation to Prevent Loss of Bone Mass in Women Immediately After Menopause
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...
Brief Summary
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
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 Type: Interventional
- Study Design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention
Intervention(s) in this Clinical Trial
- Drug: Natto capsules (food suppl.) cont. 360 microg. vit K2/day
- Drug: Placebo capsules
Outcome Measures for this Clinical Trial
Primary Measures
- Bone mass density
Criteria for Participation in this Clinical Trial
Inclusion Criteria:
- Women living in the city of Tromsø, not using hormone replacement therapy, 1-5 years after menopause.
Exclusion Criteria:
- 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
Gender Eligibility for this Clinical Trial: Female
Minimum Age for this Clinical Trial: 50 Years
Maximum Age for this Clinical Trial: 60 Years
Are Healthy Volunteers Accepted for this Clinical Trial?: Accepts Healthy Volunteers
Clinical Trial Investigator Information
Lead Investigator: University Hospital of North Norway Other
Overall Clinical Trial Officials and Contacts
Nina Emaus, MSc PhD Principal Investigator NAFKAM, Fac.of Medicine, Univ. of Tromsø, Norway
Additional Information
Information obtained from ClinicalTrials.gov on February 12, 2012
Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00290212
Study ID Number: REK V 77/2005
ClinicalTrials.gov Identifier: NCT00290212
Health Authority: Norway: Norwegian Social Science Data Services
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The URL of this page is:
http://clinicaltrialsfeeds.org/clinical-trials/show/NCT00290212
