Patients with Bone mineral density (BMD) reduction or Patients with vitamin D deficiency
Conditions
Interventions
Regular dietary supplementation with vitamin D and grape seed capsule-based health products for 12 consecutive months:Regular dietary supplementation with vitamin D and grape seed capsule-based health
Regular dietary supplementation with vitamin D for 12 consecutive months:Regular dietary supplementation with vitamin D for 12 consecutive months
Sponsors
Shanghai General Hospital
Eligibility
Sex/Gender
All
Age
40 Years to 70 Years
Inclusion criteria
Inclusion criteria: 1.Age 40-70 years (inclusive), regardless of gender; 2. Bone mineral density (BMD) reduction confirmed by dual-energy X-ray absorptiometry (DXA), defined as: T-score between -2.5 and -1.0, or Z-score = -2.0, or Serum 25-hydroxyvitamin D (25(OH)D) level < 30 ng/mL; 3. Signed informed consent obtained from the patient or their legally authorized representative (LAR);
Exclusion criteria
Exclusion criteria: 1.History of brain disorders, cardiovascular diseases, neuromuscular disorders, diabetes, bone/joint deformities, ocular diseases, gastrointestinal disorders, or abnormal liver/kidney function; 2.Any known skeletal diseases (excluding osteoporosis or other metabolic bone diseases), endocrine disorders, or rheumatic diseases that may interfere with study interpretation, including but not limited to: Paget’s disease, osteomalacia, osteogenesis imperfecta, osteopetrosis Rheumatoid arthritis, ankylosing spondylitis Cushing’s disease, hyperprolactinemia Uncontrolled thyroid disorders (hyperthyroidism/hypothyroidism) Hyperparathyroidism/hypoparathyroidism; 3.Use of the following treatments within 3 months prior to screening: Selective estrogen receptor modulators (SERMs, e.g., raloxifene, tamoxifen) Tibolone, anabolic steroids, testosterone above replacement dose Systemic hormone replacement therapy (non-stable doses) Calcitonin, bisphosphonates, fluoride, or strontium for osteoporosis treatment; 4. Other medications affecting bone metabolism, including: Anticonvulsants (except benzodiazepines) Heparin (low-molecular-weight heparin permitted) Chronic systemic ketoconazole, androgens, ACTH, cinacalcet, aluminum salts, lithium, protease inhibitors, GnRH agonists; 5.Suspected or confirmed history of alcohol or drug abuse. 6.Pregnant or lactating women, those planning pregnancy soon, or unwilling to use contraception; 7.Participation in any interventional or observational clinical trial within 3 months prior to enrollment. 8.Any condition identified via medical history, physical examination, or laboratory tests that may significantly affect study outcomes or pose additional health risks, or any other reason deemed unsuitable by the investigator;
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 12-month relative change rate of lumbar spine BMD compared to baseline; | — |
Secondary
| Measure | Time frame |
|---|---|
| Bone Mineral Density (BMD) Changes: Relative change rate in lumbar spine BMD at Month 6;Serum Bone Turnover Markers (BTMs): Dynamic trends of serum SASP (SenescenceAssociated Secretory Phenotype) biomarkers;Safety Endpoints: Adverse events (AEs) Laboratory test abnormalities and other safety-related events;Bone Mineral Density (BMD) Changes:Relative change rate in total hip BMD at Months 6 and 12;Fracture rate within 12 months; | — |
Countries
China
Outcome results
None listed