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

This study has been completed.
Sponsor:
Collaborators:
University of Tromso
The International Osteoporosis Foundation
Haukeland University Hospital
Information provided by:
University Hospital of North Norway
ClinicalTrials.gov Identifier:
NCT00290212
First received: February 9, 2006
Last updated: January 23, 2008
Last verified: December 2006
  Purpose

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 2

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
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

Resource links provided by NLM:


Further study details as provided by University Hospital of North Norway:

Primary Outcome Measures:
  • Bone mass density

Enrollment: 304
Study Start Date: January 2006
Estimated Study Completion Date: June 2007
  Eligibility

Ages Eligible for Study:   50 Years to 60 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00290212

Locations
Norway
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
Investigators
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

No publications provided

ClinicalTrials.gov Identifier: NCT00290212     History of Changes
Other Study ID Numbers: REK V 77/2005
Study First Received: February 9, 2006
Last Updated: January 23, 2008
Health Authority: Norway: Norwegian Social Science Data Services

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

ClinicalTrials.gov processed this record on October 20, 2014