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

University Hospital of North Norway

Status and phase

Completed

Phase 2

Conditions

Perimenopausal Bone Loss

Treatments

Drug: Placebo capsules

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

Study type

Interventional

Funder types

Other

Identifiers

NCT00290212

REK V 77/2005

Details and patient eligibility

About

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

Enrollment

304 patients

Sex

Female

Ages

50 to 60 years old

Volunteers

Accepts Healthy Volunteers

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