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Completed

NCT Number: NCT00290212

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

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Key information

Conditions

Perimenopausal Bone Loss Bone Diseases Bone Diseases, Metabolic Metabolic Diseases Musculoskeletal Diseases Nutritional and Metabolic Diseases Osteoporosis Osteoporosis, Postmenopausal

Age range

50 year–60 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 2

Primary location

Clinical Research Center, University Hospital of North Norway, Tromsø, Norway

Loading trial locations.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Drug

placebo capsules

Drug

Primary outcomes

  1. Bone mass density

Sponsors and collaborators

Lead sponsor

University Hospital of North Norway

Other

Collaborators

  • Haukeland University Hospital
  • The International Osteoporosis Foundation
  • University of Tromso

Registry information

Official study 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

Important dates

Study start
2006
Study completion
2007
First posted
Feb 10, 2006
Registry last updated
Jan 24, 2008

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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