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The effects of vitamin K2 combined with vitamin D supplementation on bone health and cardiovascular disease: a double-blind randomized controlled trial

The effects of vitamin K2 combined with vitamin D supplementation on bone health and cardiovascular disease: a double-blind randomized controlled trial

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2000033525
Enrollment
Unknown
Registered
2020-06-03
Start date
2020-06-05
Completion date
Unknown
Last updated
2020-10-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Osteoporosis

Interventions

Group 2:Nutritional supplements of vitamin D (400 IU/d) combined with calcium (500mg/d)
Group 3:Nutritional supplements of MK-7(72ug/d) combined with vitamin D (400 IU/d) and calcium (500mg/d)

Sponsors

School of Public Health, Shanghai Jiaotong University
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
50 Years to 65 Years

Inclusion criteria

Inclusion criteria: 1. Women aged 50-65 years; 2. Women with menopause more than 3 years; 3. Women with reduced bone mass (t-values of BMD of lumbar and hip joints are less than - 1 and more than - 2.5).

Exclusion criteria

Exclusion criteria: 1. Subjects with any diseases which may effect the metabolism of vitamin K, vitamin D, calcium and bone, shch as chronic kidney disease, hyperthyroidism, hypothyroidism, celiac disease, metabolic bone disease, etc. 2. Subjects with any critical diseases, such as cancer, chronic or paroxysmal atrial fibrillation, history of operation of coronary artery bypass grafting or coronary artery revascularization, miocardial infarction or stroke < 6 months, etc. 3. Subjects intake any drugs or supplements which may effect calcium or bone metabolism within one months, such as antibiotic, glucocorticoid, estrogen, diuretics, proton pump inhibitors, vitamin K supplements, vitamin D supplements, calcium supplements, calcium antagonists, vitamin K antagonists, vitamin D antagonists, diphosphate, etc. 4. Subjects who are participating in other clinical trial.

Design outcomes

Primary

MeasureTime frame
Bone mineral density;BAP;OC;ucOC;PINP;NTX;CAC score;CCA-IMT;

Secondary

MeasureTime frame
Calcium modulator hormone;Serum calcium;Serum vitamin D;Serum vitamin K;Blood glucose;Blood lipids;Blood pressure;Body fat;Waist circumference;BMI;Sleep;Physical activity;Intake of energy and nutrients;

Countries

China

Contacts

Public ContactXue Li

School of Public Health, Shanghai Jiaotong University

lxyolanda@126.com+86 21-63846590

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026