Natto Supplementation to Prevent Loss of Bone Mass in Women Immediately After Menopause
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
|Perimenopausal Bone Loss||Drug: Natto capsules (food suppl.) cont. 360 microg. vit K2/day Drug: Placebo capsules||Phase 2|
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
|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|
Please refer to this study by its ClinicalTrials.gov identifier: NCT00290212
|Haukeland University Hospital|
|Bergen, Norway, NO 5021|
|Clinical Research Center, University Hospital of North Norway|
|Tromsø, Norway, N-9038|
|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|