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

January 23, 2008 updated by: University Hospital of North Norway

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 Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

304

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Norway
      • Bergen, Norway, NO 5021
        • Haukeland University Hospital
      • Tromsø, Norway, N-9038
        • Clinical Research Center, University Hospital of North Norway

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

50 years to 60 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Bone mass density

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital of North Norway

Collaborators

University of Tromso
Haukeland University Hospital
The International Osteoporosis Foundation

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2006

Study Completion

June 1, 2007

Study Registration Dates

First Submitted

February 9, 2006

First Submitted That Met QC Criteria

February 9, 2006

First Posted (Estimate)

February 10, 2006

Study Record Updates

Last Update Posted (Estimate)

January 24, 2008

Last Update Submitted That Met QC Criteria

January 23, 2008

Last Verified

December 1, 2006

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • REK V 77/2005

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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