Natto Supplementation to Prevent Loss of Bone Mass in Women Immediately After Menopause - Full Text View

Purpose

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

Condition	Intervention	Phase
Perimenopausal Bone Loss	Drug: Natto capsules (food suppl.) cont. 360 microg. vit K2/day Drug: Placebo capsules	Phase II

MedlinePlus related topics:

Menopause

Drug Information available for:

Vitamin K

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Prevention, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Efficacy Study

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

Further study details as provided by University Hospital of North Norway:

Primary Outcome Measures:

Bone mass density

Enrollment:	304
Study Start Date:	January 2006
Estimated Study Completion Date:	June 2007

Eligibility

Ages Eligible for Study:	50 Years to 60 Years
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	Yes

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00290212

Locations


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

Sponsors and Collaborators

University Hospital of North Norway

University of Tromso

Norwegian Osteoporosis Society

Haukeland University Hospital

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

More Information

Study ID Numbers:	REK V 77/2005
First Received:	February 9, 2006
Last Updated:	January 23, 2008
ClinicalTrials.gov Identifier:	NCT00290212
Health Authority:	Norway: Norwegian Social Science Data Services

Keywords provided by University Hospital of North Norway:

Women

Bone density

Menopause

Dietary Supplements

Vitamin K2

Bone Density

Menopause

Study placed in the following topic categories:

Musculoskeletal Diseases

Vitamin K

Osteoporosis, Postmenopausal

Osteoporosis

Bone Diseases, Metabolic

Vitamin K 2

Bone Diseases

Menopause

ClinicalTrials.gov processed this record on October 31, 2008

Sponsors and Collaborators:	University Hospital of North Norway University of Tromso Norwegian Osteoporosis Society Haukeland University Hospital
Information provided by:	University Hospital of North Norway
ClinicalTrials.gov Identifier:	NCT00290212