Vitamin K Supplementation in Post-Menopausal Osteopenia

NCT00150969 | Completed Phase 3 Results DMC

• 2 other identifiers: 01-016950422
• Study Type: interventional
• Target: 440
• Locations: 1 country
• Sites: 5

Brief Summary

The purpose of this study is to determine whether supplementation with 5 mg vitamin K daily over a 2-year period will prevent bone loss in post-menopausal women with osteopenia.

Conditions

Post-Menopausal Osteoporosis; Post-Menopausal Osteopenia

Keywords

vitamin K; bone mineral density; post-menopausal women; randomized double blind placebo controlled trial; osteoporosis; women's health

Outcome Measures

Primary Outcomes (2)

• Percent Change in Bone Mineral Density (BMD) at the Lumbar Spine (L1-L4) Between Treatment Arms.

  BMD was measured yearly on one scanner at UHN using DEXA Hologic 4500A densitometer

  0 to 24 months

• Percent Change in Bone Mineral Density (BMD) at the Total Hip Between Treatment Arms.

  BMD was measured yearly on one scanner at UHN using DEXA Hologic 4500A densitometer

  0 to 24 months

Secondary Outcomes (12)

• Percent Change in Bone Mineral Density (BMD) at the Femoral Neck Between Treatment Arms.

  0 to 24 months

• Percent Change in Bone Mineral Density (BMD) at the Ultra-distal Radius Between Treatment Arms.

  0 to 24 months

• Effect of Vitamin K1 Supplementation on Levels of Bone Formation Marker

  0-24 months

• Effect of Vitamin K1 Supplementation on Level of Bone Resorption Markers (C-telopeptide: CTX)

  0-24 months

• Effect of Vitamin K1 Supplementation on Percent of Carboxylation of Osteocalcin

  0 to 24 months

Study Arms (2)

phyloquinone

EXPERIMENTAL

5 mg Vitamin K1

Dietary Supplement: vitamin K1 (phylloquinone)

placebo

PLACEBO COMPARATOR

Dietary Supplement: placebo

Interventions

vitamin K1 (phylloquinone) DIETARY_SUPPLEMENT

phyloquinone

placebo DIETARY_SUPPLEMENT

1 pill daily

placebo

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Postmenopausal: One year since the natural cessation of menses, or Hysterectomy with either postmenopausal status confirmed by FSH lab values, or age 55 and above AND 2. Osteopenic: T-score at baseline has to be between (and including) -1.0 and
• in the lumbar spine (L1-L4), total hip or femoral neck, and the lowest reading of the above three measurements must be between -1.0 and -2.0

You may not qualify if:

• Women ever having had a fragility fracture after age 40;
• Women currently on anticoagulants, previously on anticoagulants in the past 3 months, or expected to be on anticoagulants in the near future;
• Women on hormone replacement therapy, raloxifene, bisphosphonates or calcitonin during the past 3 months;
• Women who have ever been on a bisphosphonate for more than 6 months;
• Women previously diagnosed with Paget's disease, hyperparathyroidism, hyperthyroidism or other metabolic bone diseases;
• Women with decompensated diseases of the liver, kidney, pancreas, lung, or heart;
• Women with a history of active cancer in the past 5 years;
• Women taking mega-doses of vitamin A (more than 10,000 iu per day) or E (more than 400 iu per day);
• Women involved in other clinical trials;
• Any women who, in the opinion of the principal investigator, is at poor medical or psychiatric risk for the study.

Sponsors & Collaborators

• University Health Network, Toronto: lead
• Canadian Institutes of Health Research (CIHR): collaborator

Study Sites (5)

St. Michael's Hospital Health Centre

Toronto, Ontario, M5C 2T2, Canada

Location

Mt. Sinai Hospital

Toronto, Ontario, M5G 1X5, Canada

Location

University Health Network, Osteoporosis Department

Toronto, Ontario, M5G 2C4, Canada

Location

Sunnybrook & Women's College Health Sciences Centre

Toronto, Ontario, M5S 1B2, Canada

Location

University of Toronto

Toronto, Ontario, M5S 3E2, Canada

Location

Related Publications (1)

• Cheung AM, Tile L, Lee Y, Tomlinson G, Hawker G, Scher J, Hu H, Vieth R, Thompson L, Jamal S, Josse R. Vitamin K supplementation in postmenopausal women with osteopenia (ECKO trial): a randomized controlled trial. PLoS Med. 2008 Oct 14;5(10):e196. doi: 10.1371/journal.pmed.0050196.

  PMID: 18922041 RESULT

MeSH Terms

Conditions

Osteoporosis, Postmenopausal; Osteoporosis

Interventions

Vitamin K 1

Condition Hierarchy (Ancestors)

Bone Diseases, Metabolic; Bone Diseases; Musculoskeletal Diseases; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Vitamin K; Naphthoquinones; Naphthalenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Phytol; Diterpenes; Terpenes; Quinones; Polycyclic Compounds

Limitations and Caveats

Originally designed as a 2-year study with BMD as primary outcome. Thus, the number of women followed to 3 and 4 years was small, and the study was not powered to examine fracture outcomes.

Results Point of Contact

• Title: Dr. Angela M Cheung
• Organization: University Health Network

jscher@uhnresearch.ca

416-340-4841

Study Officials

• Angela M Cheung, MD, PhD

  University Health Network, University of Toronto

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 6, 2005
• First Posted: September 8, 2005
• Study Start: January 1, 2002
• Primary Completion: September 1, 2006
• Study Completion: September 1, 2007
• Last Updated: December 28, 2023
• Results First Posted: March 26, 2012

Record last verified: 2023-12

Locations

CA (5)