Vertebral compression fracture
Conditions
Interventions
Daily consumption of one cup of juice fortified with vitamin D supplements (2000 IU) for six weeks
Daily consumption of one cup of juice without vitamin D fortification
Sponsors
Department of Research, Heisei Medical Welfare Group Research Institute
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Men and women aged 65 years or older at the time of admission. Hospitalized for rehabilitation following vertebral compression fractures: thoracic or lumbar vertebral fractures. Vitamin D deficiency: Serum 25-hydroxyvitamin D less than 30 nanograms per milliliter at admission Presence of Sarcopenia: Assessed at the time of admission based on the definition by the Asian Working Group for Sarcopenia 2019 (characterized by reduced muscle strength or physical performance, along with decreased skeletal muscle mass). Barthel Index walking score less than or equal to 10 at admission. During the baseline evaluation period, dietary energy intake meets at least 80% of the required nutritional intake.
Exclusion criteria
Exclusion criteria: Mini-Mental State Examination MMSE score less than 10 at the time of admission. Use of implantable devices such as pacemakers. Conditions that make nutritional interventions difficult such as allergies to vitamin D or dairy products. Use of other nutritional supplements calcium preparations or medications related to vitamin D. Expected to be discharged within one month of admission. Body Mass Index BMI greater than or equal to 25. Presence of the following diseases that may cause adverse effects from nutritional interventions. Kidney disease estimated glomerular filtration rate less than 30 mL per min Thyroid disorders Hypercalcemia Active cancer Liver dysfunction Child-Pugh class B or C Inability to perform resistance exercises due to weight-bearing restrictions. Requiring long-term care level 4 or 5 prior to the current vertebral compression fracture. Paralysis of the limbs or neuromuscular diseases. Inability to obtain oral nutritional intake due to dysphagia. Presence of severe or unstable medical conditions. Participation in other clinical trials.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| ADL at the end of the intervention: To be evaluated using the Barthel Index score six weeks after randomization. The evaluation of patients discharged early will be conducted via a telephone survey 6 weeks after randomization. | — |
Secondary
| Measure | Time frame |
|---|---|
| At the end of the intervention (at six weeks post-randomization): Skeletal Muscle mass Index, Phase Angle, Grip Strength, Gait Speed, Short Physical Performance Battery Score, Tongue Pressure, Serum 25-Hydroxyvitamin D [25(OH)D] Level, Pain Severity (Numerical Rating Scale) ADL three months after the completion of the intervention: To be assessed using the Barthel Index score. | — |
Countries
Japan
Contacts
Public ContactKotomi Sakai
Heisei Medical Welfare Group Research Institute Department of Research
Outcome results
None listed