vitamin D deficiency and osteopenia
Conditions
Interventions
Intensive-lifestyle group:Health education and distribution of healthy lifestyle pamphlets
Intensive-lifestyle and vitamin D supplementation group:Vitamin D supplementation
Intensive-lifestyle and vitamin D and vitamin K supplementation group:Vitamin D and vitamin K supplementation
Sponsors
The Second Medical Center of PLA General Hospital
Eligibility
Sex/Gender
Male
Age
60 Years to 90 Years
Inclusion criteria
Inclusion criteria: ? Male individuals aged =60 years; ? Individuals of Han ethnicity; ? Residing in Beijing; ? Diagnosed with vitamin D deficiency: serum 25(OH)D<20 ng/ml; ? Diagnosed with osteopenia (bone mineral density (BMD) measured by DXA: -2.5< T-score <-1.0 or BMD measured by QCT: 80<BMD<120 mg/cm3); ? Providing signed informed consent.
Exclusion criteria
Exclusion criteria: ? Individuals with aphagous, chronic gastrointestinal disorders impacting digestion and nutrient absorption, or prolonged usage of gastric mucosal protective agents or gastrointestinal surgery; ? Individuals with severe cardiovascular and cerebrovascular conditions; ? Individuals with severe liver disease or transaminase levels =3 times the upper limit of normal; ? Individuals with severe kidney disease or eGFR<30 ml/min/1.73m^2 calculated by CKD-EPI formula; ? Individuals with primary hyperparathyroidism/hypoparathyroidism; ? Individuals diagnosed with malignant tumors; ? Individuals with prolonged administration of corticosteroids, rifampicin, isoniazid, phenobarbital, ketoconazole and other medications affecting vitamin D metabolism; ? Individuals with hypercalcemia and kidney stones, who are not suitable for vitamin D supplementation; ? Individuals who are currently undergoing treatment involving vitamin D supplements, menadione or other anti-osteoporosis drugs; ? Individuals who suffered from (within the past 3 months) severe infection, acute myocardial infarction, inflammation, trauma,diabetic ketoacidosis or hyperglycemic hyperosmolar syndrome,hyperthyroidism and hypercortisolism.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 25-hydroxyvitamin D [25(OH)D];Bone mineral density; | — |
Secondary
| Measure | Time frame |
|---|---|
| Parathyroid hormone (PTH);Procollagen I N-Terminal Propeptide (PINP);carboxy-terminal cross-linked telopeptide of type 1 collagen (CTX);Osteocalcin;Serum calcium; | — |
Countries
China
Contacts
Public ContactChunlin Li
Chinese PLA General Hospital
Outcome results
None listed