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Natto Supplementation to Prevent Loss of Bone Mass in Women Immediately After Menopause

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ClinicalTrials.gov Identifier: NCT00290212
Recruitment Status : Completed
First Posted : February 10, 2006
Last Update Posted : January 24, 2008
Information provided by:

Study Description
Brief 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.

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 or disease Intervention/treatment Phase
Perimenopausal Bone Loss Drug: Natto capsules (food suppl.) cont. 360 microg. vit K2/day Drug: Placebo capsules Phase 2

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 304 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
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 Start Date : January 2006
Estimated Study Completion Date : June 2007

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Outcome Measures

Primary Outcome Measures :
  1. Bone mass density

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   50 Years to 60 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes

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
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00290212

Haukeland University Hospital
Bergen, Norway, NO 5021
Clinical Research Center, University Hospital of North Norway
Tromsø, Norway, N-9038
Sponsors and Collaborators
University Hospital of North Norway
University of Tromso
The International Osteoporosis Foundation
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
More Information

ClinicalTrials.gov Identifier: NCT00290212     History of Changes
Other Study ID Numbers: REK V 77/2005
First Posted: February 10, 2006    Key Record Dates
Last Update Posted: January 24, 2008
Last Verified: December 2006

Keywords provided by University Hospital of North Norway:
Bone density
Dietary Supplements
Vitamin K2