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

NCT00290212 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 304

Last updated 2008-01-24

No results posted yet for this study

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

DRUG

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

DRUG

Placebo capsules

Sponsors & Collaborators

  • University of Tromso

    collaborator OTHER

  • The International Osteoporosis Foundation

    collaborator OTHER

  • Haukeland University Hospital

    collaborator OTHER

  • University Hospital of North Norway

    lead OTHER

Principal Investigators

  • Nina Emaus, MSc PhD · NAFKAM, Fac.of Medicine, Univ. of Tromsø, Norway

  • Sameline Grimsgaard, MD, MPH, PhD · University Hospital of North Norway

  • Vinjar Fønnebø, MD, MSc, PhD · NAFKAM, University of Tromsø, Norway

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
50 Years
Max Age
60 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2006-01-31
Completion
2007-06-30

Countries

  • Norway

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00290212 on ClinicalTrials.gov