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

Phase 2

Completed

• Conditions: Perimenopausal Bone Loss

• Registration Number: NCT00290212
• Lead Sponsor: University Hospital of North Norway

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

Detailed Description

Not available

Study Timeline

• Study Start: 2006-01
• Study First Submitted: 2006-02-09
• Study First Submitted QC: 2006-02-09
• Study First Posted: 2006-02-10
• Status Verified: 2006-12
• Study Completion: 2007-06
• Last Update Submitted: 2008-01-23
• Last Update Posted: 2008-01-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 304

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Bone mass density

Trial Locations

Locations (2)

Clinical Research Center, University Hospital of North Norway; 🇳🇴 Tromsø, Norway

Haukeland University Hospital; 🇳🇴 Bergen, Norway