NCT00290212

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

Phase II Study of Natto Supplementation to Prevent Loss of Bone Mass in Women Immediately After Menopause: a Randomised Double Blind Placebo-Controlled Trial

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 304 (actual)
• Sponsor: University Hospital of North Norway · Academic / Other
• Sex: Female
• Age: 50 Years – 60 Years
• Healthy volunteers: Accepted

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

Conditions

• Perimenopausal Bone Loss

Interventions

Type	Name	Description
DRUG	Natto capsules (food suppl.) cont. 360 microg. vit K2/day
DRUG	Placebo capsules

Timeline

• Start date: 2006-01-01
• Completion: 2007-06-01
• First posted: 2006-02-10
• Last updated: 2008-01-24

Locations

2 sites across 1 country: Norway