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

Perimenopausal Bone Loss Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00290212
• Other study ID #: REK V 77/2005
• Status: Completed
• Phase: Phase 2
• First received: February 9, 2006
• Last updated: January 23, 2008
• Start date: January 2006
• Est. completion date: June 2007

Study information

• Verified date: December 2006
• Source: University Hospital of North Norway
• Contact: n/a
• Is FDA regulated: No
• Health authority: Norway: Norwegian Social Science Data Services
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 304
• Est. completion date: June 2007
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 50 Years to 60 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Perimenopausal Bone Loss

Intervention

Drug:
• Natto capsules (food suppl.) cont. 360 microg. vit K2/day

• Placebo capsules

Locations

Country	Name	City	State
Norway	Haukeland University Hospital	Bergen
Norway	Clinical Research Center, University Hospital of North Norway	Tromsø

Sponsors (4)

Lead Sponsor	Collaborator
University Hospital of North Norway	Haukeland University Hospital, The International Osteoporosis Foundation, University of Tromso

Country where clinical trial is conducted

Norway, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Bone mass density