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The epidemiological investigation of serum Vitamin D levels and the prevalence of osteoporosis and sarcopenia among Chinese elderly and a multi-center randomized controlled study of the effect of vitamin D and nutritional supplement on osteo-sarcopenia

The epidemiological investigation of serum Vitamin D levels and the prevalence of osteoporosis and sarcopenia among Chinese elderly and a multi-center randomized controlled study of the effect of vitamin D and nutritional supplement on osteo-sarcopenia

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2000040279
Enrollment
Unknown
Registered
2020-11-27
Start date
2021-11-01
Completion date
Unknown
Last updated
2021-02-16

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

Conditions

osteoporosis and sarcopenia

Interventions

2:common Vit D
3:activated vitamin D
4:common vitD+nutrition
5:activated VitD+nutrition

Sponsors

Zhongshan Hospital affiliated Fudan University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
65 Years to 105 Years

Inclusion criteria

Inclusion criteria: 1. Inclusion criteria of cross-sectional investigation: (1) Aged >=65 years; (3) Volunteer to participate in this study and sign the informed consent. 2. Inclusion criteria for the randomized controlled study: (1) Aged >=65 years; (2) No previous or current usage of oral vitamin D, glucocorticoid and other drugs which affect blood VitD level; (3)reduced bone mass or reduced skeletal muscle mass confirmed by DXA; (4) serum 25(OH) Vit D < 50ng/l; (5) Volunteer to participate in this study and sign the informed consent.

Exclusion criteria

Exclusion criteria: (1) already participated in other drug clinical trials; (2) unable to complete grip strength assessment and scale survey; (3) abnormal spirits; (4) severe liver or renal insufficiency, acute stage of chronic diseases, patients with malignant tumors and other major diseases whose expected survival time is less than 1 year; (5) In the acute and critical stage of acute infection, cardiovascular and cerebrovascular events and other diseases (6) use drugs that affect body components, such as vitamin D, bisphosphonates and glucocorticoids; (7) Hypercalcemia; (8) Patients requires a low-protein diet; (9) Refuse to participate in the clinical trial.

Design outcomes

Primary

MeasureTime frame
skeletal muscle mass;grip strength;bone mineral density;fracture;

Secondary

MeasureTime frame
Frail Scale;

Countries

China

Contacts

Public ContactHu Yu

Zhongshan Hospital affiliated to Fudan University

hu.yu@zs-hospital.sh.cn+86 13681972309

Outcome results

None listed

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