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
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

Additional relevant MeSH terms:
Osteoporosis, Postmenopausal
Osteoporosis
Bone Diseases, Metabolic
Bone Diseases
Musculoskeletal Diseases

ClinicalTrials.gov processed this record on April 17, 2014