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| ID | Type | Description | Link |
|---|---|---|---|
| R01AG042411 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute on Aging (NIA) | NIH |
| Office of Dietary Supplements (ODS) | NIH |
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The purpose of this study is to see if vitamin D supplementation improves muscle function in older adults.
This study is a 12-month, double-blind randomized placebo controlled trial in older (65-89 yrs) men and women with initial 25(OH)D concentrations of 18-<30 ng/mL to determine the effect of increasing 25(OH)D concentrations to ≥30 ng/mL through vitamin D3 supplementation on 1) change in neuromuscular functions that are established risk-factors for falls in older adults; and 2) changes in the underlying physiological mechanisms over 4 months in a subset of randomly selected participants. Participants will be randomized to 2000 IU/d of vitamin D3 or placebo. Lower extremity muscle strength and power, physical performance, and postural sway will be assessed at baseline, 4 months and 12 months and falls assessed monthly. Muscle biopsies of the vastus lateralis will be taken at baseline and 4 months to assess muscle fiber type, contractility, and denervation, and number and differentiation stage of satellite cells.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo | Placebo Comparator | Matched bottle/pill placebo |
|
| Vitamin D | Experimental | 2,000 IU Vitamin D3 per day |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Vitamin D | Dietary Supplement | 2,000 IU/ day of Vitamin D3 |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Lower Extremity Muscle Power Over 12 Months | Lower extremity muscle power will be measured at baseline, 4- and 12-month follow-up using the Nottingham Power Rig. Participants sit in a chair and unilaterally depress a foot lever attached to a flywheel as hard and as fast as they can. Power output, derived from the acceleration of the flywheel from 5 trials on each leg at maximal effort, will be recorded in Watts. Maximum leg power at baseline (from either the right or left leg) and the maximum power from the same leg at 4- and 12-month follow-up will be used in all analyses. Leg power (Watts) will be standardized to total body mass (in Kg). | change from baseline at 12 month follow-up reported |
| Change in Percentage of Type II (Fast-twitch) Muscle Fibers Over 4 Months | This will be examined in muscle biopsies collected at baseline and 4-month follow-up using the ATPase, pH 9.4 technique, combined with laminin immunostaining in 10 micrometer muscle sections and the number of type I and type II fiber subtypes quantified. The percentage of type II fibers is calculated by dividing the number of type II fibers by the sum of type I and type II fibers combined. | over 4 months of follow-up |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Lower Extremity Muscle Strength Over 12 Months | Lower extremity muscle strength will be measured using an isokinetic dynamometer (Biodex) at one speed (60°/sec) with the participant sitting and the hips and knee flexed at 90°. Participants extend the knee and push as hard as possible against the resistance pad. Strength is expressed as peak torque in Newton-meters (Nm). The maximum knee extensor strength of the 4 repetitions from trial 2 for the dominant leg will be will be used in analyses unless unable to test the dominant leg (i.e., knee replacement) in which case the non-dominant leg will be used; the maximum knee extensor strength from the same leg will be used at 4- and 12-month follow-up for all analyses. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Falls Over 12 Months | Falls will be defined as an event whereby an individual unexpectedly comes to rest on the ground or another lower level. Participants will be provided monthly fall calendars and asked to mark any falls that occur on the calendar. Completion of monthly fall calendars will be monitored via monthly phone calls and collected at the 4- and 12-month visits. The number of total falls per participant over the entire 12-month follow-up period will be used in analysis. |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Denise K Houston, PhD, RD | Wake Forest University Health Sciences | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Wake Forest University Health Sciences | Winston-Salem | North Carolina | 27157 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37084814 | Derived | Houston DK, Marsh AP, Neiberg RH, Demons JL, Campos CL, Kritchevsky SB, Delbono O, Tooze JA. Vitamin D Supplementation and Muscle Power, Strength and Physical Performance in Older Adults: A Randomized Controlled Trial. Am J Clin Nutr. 2023 Jun;117(6):1086-1095. doi: 10.1016/j.ajcnut.2023.04.021. Epub 2023 Apr 19. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Placebo | Matched bottle/pill placebo Placebo: Placebo |
| FG001 | Vitamin D | 2,000 IU Vitamin D3 per day Vitamin D: 2,000 IU/ day of Vitamin D3 |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Placebo | Matched bottle/pill placebo Placebo: Placebo |
| BG001 | Vitamin D | 2,000 IU Vitamin D3 per day Vitamin D: 2,000 IU/ day of Vitamin D3 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Change in Lower Extremity Muscle Power Over 12 Months | Lower extremity muscle power will be measured at baseline, 4- and 12-month follow-up using the Nottingham Power Rig. Participants sit in a chair and unilaterally depress a foot lever attached to a flywheel as hard and as fast as they can. Power output, derived from the acceleration of the flywheel from 5 trials on each leg at maximal effort, will be recorded in Watts. Maximum leg power at baseline (from either the right or left leg) and the maximum power from the same leg at 4- and 12-month follow-up will be used in all analyses. Leg power (Watts) will be standardized to total body mass (in Kg). | 4 participants in the placebo arm and 3 participants in the vitamin D arm were missing the leg power outcome at 12-month follow-up | Posted | Least Squares Mean | Standard Error | Watts/kg | change from baseline at 12 month follow-up reported |
|
12 months
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Placebo | Matched bottle/pill placebo Placebo: Placebo | 0 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Hospitalization | Gastrointestinal disorders | Non-systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Arthritis | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Denise Houston | Wake Forest University School of Medicine | 336-713-8217 | dhouston@wakehealth.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Apr 16, 2020 | Sep 8, 2022 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D014807 | Vitamin D |
| ID | Term |
|---|---|
| D012632 | Secosteroids |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
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| Placebo |
| Dietary Supplement |
Placebo |
|
| change from baseline at 12 month follow-up reported |
| Change in the Short Physical Performance Battery (SPPB) Score Over 12 Months | The short physical performance battery consists of standing balance (side-by-side, semi- and full-tandem stands for 10 seconds), a 4-m walk to assess usual gait speed, and 5 repeated chair stands at baseline, 4-months and 12-months. Each of the three performance measures is assigned a score ranging from 0 (inability to perform the task) to 4 (the highest level of performance) and summed to create an SPPB score ranging from 0 to 12 (best). | change from baseline at 12 month follow-up reported |
| Change in the Expanded Physical Performance Battery Score Over 12 Months | The expanded physical performance battery consists of standing balance (semi- and full-tandem stands and a single leg stand for 30 seconds), a 4-m walk to assess usual gait speed, a narrow 4-m walk test of balance (walking at usual pace within lines of tape spaced 20 cm apart), and 5 repeated chair stands at baseline, 4-months, and 12-months. Scores range from 0 to 4 with higher scores indicative of better physical performance. | change from baseline at 12 month follow-up reported |
| Change in Timed Up and Go (TUG) Over 12 Months | The timed up and go will be measured by how long it takes (sec) to stand up from a chair, walk 3 m, turn around, walk back to the chair, and sit down at baseline, 4-months, and 12-months. Longer times to complete the TUG are indicative of greater fall risk. | change from baseline at 12 month follow-up reported |
| Change in Average Sway Velocity Over 12 Months | Postural sway during quiet stance will be assessed from Center-of-Pressure (COP) trajectory data collected at 100 Hz using an Advanced Mechanical Technology Incorporated (AMTI) AccuSway biomechanics force platform at baseline, 4-months, and 12-months. Participants stand on the force platform barefoot in an upright stance with arms relaxed comfortably at their sides, eyes open, feet abducted 10 degrees, and heels separated medio-laterally by 6 cm. COP data is collected in a series of 10 30-sec trials standing on the force plate. Average sway velocity is measured in cm/sec. A higher number indicates more postural sway. | change from baseline at 12 month follow-up reported |
| Change in 95% Confidence Ellipse Area Over 12 Months | Postural sway during quiet stance will be assessed from Center-of-Pressure (COP) trajectory data collected at 100 Hz using an Advanced Mechanical Technology Incorporated (AMTI) AccuSway biomechanics force platform at baseline, 4-months, and 12-month. Participants stand on the force platform barefoot in an upright stance with arms relaxed comfortably at their sides, eyes open, feet abducted 10 degrees, and heels separated medio-laterally by 6 cm. COP data is collected in a series of 10 30-sec trials standing on the force plate. 95% confidence ellipse area is measured in cm squared. A higher number indicates more postural sway. | change from baseline at 12 month follow-up reported |
| Change in Maximum Anteroposterior (AP) Displacement Over 12 Months | Postural sway during quiet stance will be assessed from Center-of-Pressure (COP) trajectory data collected at 100 Hz using an Advanced Mechanical Technology Incorporated (AMTI) AccuSway biomechanics force platform at baseline, 4-months, and 12-months. Participants stand on the force platform barefoot in an upright stance with arms relaxed comfortably at their sides, eyes open, feet abducted 10 degrees, and heels separated medio-laterally by 6 cm. COP data is collected in a series of 10 30-sec trials standing on the force plate. Anteroposterior (AP) displacement is measured in cm. A higher number indicates more postural sway. | change from baseline at 12 month follow-up reported |
| Change in Maximum Mediolateral (ML) Displacement Over 12 Months | Postural sway during quiet stance will be assessed from Center-of-Pressure (COP) trajectory data collected at 100 Hz using an Advanced Mechanical Technology Incorporated (AMTI) AccuSway biomechanics force platform at baseline, 4-months, and 12-months. Participants stand on the force platform barefoot in an upright stance with arms relaxed comfortably at their sides, eyes open, feet abducted 10 degrees, and heels separated medio-laterally by 6 cm. COP data is collected in a series of 10 30-sec trials standing on the force plate. Mediolateral (ML) displacement is measured in cm. A higher number indicates more postural sway. | change from baseline at 12 month follow-up reported |
| monthly over 12 months |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Short Physical Performance Battery Score | The scores range from 0 (worst performance) to 12 (best performance). | Least Squares Mean | Standard Deviation | score on a scale |
|
Matched bottle/pill placebo
Placebo: Placebo
| OG001 | Vitamin D | 2,000 IU Vitamin D3 per day Vitamin D: 2,000 IU/ day of Vitamin D3 |
|
|
|
| Primary | Change in Percentage of Type II (Fast-twitch) Muscle Fibers Over 4 Months | This will be examined in muscle biopsies collected at baseline and 4-month follow-up using the ATPase, pH 9.4 technique, combined with laminin immunostaining in 10 micrometer muscle sections and the number of type I and type II fiber subtypes quantified. The percentage of type II fibers is calculated by dividing the number of type II fibers by the sum of type I and type II fibers combined. | Subset of participants from main trial with muscle biopsy at baseline and 4 months | Posted | Least Squares Mean | Standard Error | Percent of type II muscle fibers | over 4 months of follow-up |
|
|
|
|
| Secondary | Change in Lower Extremity Muscle Strength Over 12 Months | Lower extremity muscle strength will be measured using an isokinetic dynamometer (Biodex) at one speed (60°/sec) with the participant sitting and the hips and knee flexed at 90°. Participants extend the knee and push as hard as possible against the resistance pad. Strength is expressed as peak torque in Newton-meters (Nm). The maximum knee extensor strength of the 4 repetitions from trial 2 for the dominant leg will be will be used in analyses unless unable to test the dominant leg (i.e., knee replacement) in which case the non-dominant leg will be used; the maximum knee extensor strength from the same leg will be used at 4- and 12-month follow-up for all analyses. | Participants excluded from testing if they had ever had knee surgery, had difficulty bending/straightening either of their knees fully due to pain, arthritis, injury, or other condition, or experienced pain upon testing. At baseline, only 60 participants in the placebo group and 55 participants in the vitamin D group were able to test. At 12-month follow-up, only 50 participants in the placebo and 45 participants in the vitamin D group were able to test. | Posted | Least Squares Mean | Standard Error | Newton meters | change from baseline at 12 month follow-up reported |
|
|
|
|
| Secondary | Change in the Short Physical Performance Battery (SPPB) Score Over 12 Months | The short physical performance battery consists of standing balance (side-by-side, semi- and full-tandem stands for 10 seconds), a 4-m walk to assess usual gait speed, and 5 repeated chair stands at baseline, 4-months and 12-months. Each of the three performance measures is assigned a score ranging from 0 (inability to perform the task) to 4 (the highest level of performance) and summed to create an SPPB score ranging from 0 to 12 (best). | 2 participants in the placebo group and 4 in the vitamin D group were excluded from analyses: 4 participants because they used an assistive device during testing at follow-up but not at baseline (1 in the placebo group and 3 in the vitamin D group); 1 participant because of severe knee pain and limping at follow-up (placebo group); and 1 participant was in a walking boot at 12-month follow-up (vitamin D group). | Posted | Least Squares Mean | Standard Error | score on a scale | change from baseline at 12 month follow-up reported |
|
|
|
|
| Secondary | Change in the Expanded Physical Performance Battery Score Over 12 Months | The expanded physical performance battery consists of standing balance (semi- and full-tandem stands and a single leg stand for 30 seconds), a 4-m walk to assess usual gait speed, a narrow 4-m walk test of balance (walking at usual pace within lines of tape spaced 20 cm apart), and 5 repeated chair stands at baseline, 4-months, and 12-months. Scores range from 0 to 4 with higher scores indicative of better physical performance. | 14 participants in the placebo group and 10 in the vitamin D group were excluded from analyses: 4 participants because they used an assistive device during testing at follow-up but not at baseline (1 in the placebo group and 3 in the vitamin D group); 1 participant because of severe knee pain and limping at follow-up (placebo group); 1 participant was in a walking boot at 12-month follow-up (vitamin D group); and 12 in the placebo group and 6 in the vitamin D group due to change >2 IQR | Posted | Least Squares Mean | Standard Error | score on a scale | change from baseline at 12 month follow-up reported |
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|
|
|
| Secondary | Change in Timed Up and Go (TUG) Over 12 Months | The timed up and go will be measured by how long it takes (sec) to stand up from a chair, walk 3 m, turn around, walk back to the chair, and sit down at baseline, 4-months, and 12-months. Longer times to complete the TUG are indicative of greater fall risk. | 6 participants in the placebo group and 6 in the vitamin D group were excluded from analyses due to: 1 participant with foot pain (placebo group), 1 participant with knee pain and limping (placebo group), 3 participants using an aid at follow-up but not at baseline (2 placebo and 1 vitamin D group), 1 participant with vertigo (placebo group), and 6 participants with change >2 IQR (1 placebo group, 5 vitamin D group) | Posted | Least Squares Mean | Standard Error | seconds | change from baseline at 12 month follow-up reported |
|
|
|
|
| Secondary | Change in Average Sway Velocity Over 12 Months | Postural sway during quiet stance will be assessed from Center-of-Pressure (COP) trajectory data collected at 100 Hz using an Advanced Mechanical Technology Incorporated (AMTI) AccuSway biomechanics force platform at baseline, 4-months, and 12-months. Participants stand on the force platform barefoot in an upright stance with arms relaxed comfortably at their sides, eyes open, feet abducted 10 degrees, and heels separated medio-laterally by 6 cm. COP data is collected in a series of 10 30-sec trials standing on the force plate. Average sway velocity is measured in cm/sec. A higher number indicates more postural sway. | 14 participants in the placebo group and 10 in the vitamin D group were excluded from analysis: 1 participant with a foot in a walking boot (vitamin D group), 1 participant with foot pain (placebo group), 1 participant with severe knee pain (placebo group), and 12 in the placebo group and 9 in the vitamin D group due to change >2 IQR | Posted | Least Squares Mean | Standard Error | cm/sec | change from baseline at 12 month follow-up reported |
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|
|
|
| Secondary | Change in 95% Confidence Ellipse Area Over 12 Months | Postural sway during quiet stance will be assessed from Center-of-Pressure (COP) trajectory data collected at 100 Hz using an Advanced Mechanical Technology Incorporated (AMTI) AccuSway biomechanics force platform at baseline, 4-months, and 12-month. Participants stand on the force platform barefoot in an upright stance with arms relaxed comfortably at their sides, eyes open, feet abducted 10 degrees, and heels separated medio-laterally by 6 cm. COP data is collected in a series of 10 30-sec trials standing on the force plate. 95% confidence ellipse area is measured in cm squared. A higher number indicates more postural sway. | 14 participants in the placebo group and 10 in the vitamin D group were excluded from analysis: 1 participant with a foot in a walking boot (vitamin D group), 1 participant with foot pain (placebo group), 1 participant with severe knee pain (placebo group), and 12 in the placebo group and 9 in the vitamin D group due to change >2 IQR | Posted | Least Squares Mean | Standard Error | cm squared | change from baseline at 12 month follow-up reported |
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|
|
| Secondary | Change in Maximum Anteroposterior (AP) Displacement Over 12 Months | Postural sway during quiet stance will be assessed from Center-of-Pressure (COP) trajectory data collected at 100 Hz using an Advanced Mechanical Technology Incorporated (AMTI) AccuSway biomechanics force platform at baseline, 4-months, and 12-months. Participants stand on the force platform barefoot in an upright stance with arms relaxed comfortably at their sides, eyes open, feet abducted 10 degrees, and heels separated medio-laterally by 6 cm. COP data is collected in a series of 10 30-sec trials standing on the force plate. Anteroposterior (AP) displacement is measured in cm. A higher number indicates more postural sway. | 14 participants in the placebo group and 10 in the vitamin D group were excluded from analysis: 1 participant with a foot in a walking boot (vitamin D group), 1 participant with foot pain (placebo group), 1 participant with severe knee pain (placebo group), and 12 in the placebo group and 9 in the vitamin D group due to change >2 IQR | Posted | Least Squares Mean | Standard Error | cm | change from baseline at 12 month follow-up reported |
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|
|
| Secondary | Change in Maximum Mediolateral (ML) Displacement Over 12 Months | Postural sway during quiet stance will be assessed from Center-of-Pressure (COP) trajectory data collected at 100 Hz using an Advanced Mechanical Technology Incorporated (AMTI) AccuSway biomechanics force platform at baseline, 4-months, and 12-months. Participants stand on the force platform barefoot in an upright stance with arms relaxed comfortably at their sides, eyes open, feet abducted 10 degrees, and heels separated medio-laterally by 6 cm. COP data is collected in a series of 10 30-sec trials standing on the force plate. Mediolateral (ML) displacement is measured in cm. A higher number indicates more postural sway. | 14 participants in the placebo group and 10 in the vitamin D group were excluded from analysis: 1 participant with a foot in a walking boot (vitamin D group), 1 participant with foot pain (placebo group), 1 participant with severe knee pain (placebo group), and 12 in the placebo group and 9 in the vitamin D group due to change >2 IQR | Posted | Least Squares Mean | Standard Error | cm | change from baseline at 12 month follow-up reported |
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| Other Pre-specified | Number of Falls Over 12 Months | Falls will be defined as an event whereby an individual unexpectedly comes to rest on the ground or another lower level. Participants will be provided monthly fall calendars and asked to mark any falls that occur on the calendar. Completion of monthly fall calendars will be monitored via monthly phone calls and collected at the 4- and 12-month visits. The number of total falls per participant over the entire 12-month follow-up period will be used in analysis. | 1 participant in the placebo group and 4 participants in the vitamin D group did not return their falls calendar | Posted | Mean | Standard Deviation | number of falls | monthly over 12 months |
|
|
|
| 70 |
| 12 |
| 70 |
| 29 |
| 70 |
| EG001 | Vitamin D | 2,000 IU Vitamin D3 per day Vitamin D: 2,000 IU/ day of Vitamin D3 | 0 | 66 | 6 | 66 | 16 | 66 |
| Hospitalization | Cardiac disorders | Non-systematic Assessment |
|
| Hospitalization | Blood and lymphatic system disorders | Non-systematic Assessment |
|
| Hospitalization | Ear and labyrinth disorders | Non-systematic Assessment |
|
| Hospitalization | Immune system disorders | Non-systematic Assessment |
|
| Hospitalization | Hepatobiliary disorders | Non-systematic Assessment |
|
| Hospitalization | Infections and infestations | Non-systematic Assessment |
|
| Life threatening illness or accident | Injury, poisoning and procedural complications | Non-systematic Assessment |
|
| Hospitalization | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
|
| Hospitalization | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Non-systematic Assessment |
|
| Hospitalization | Nervous system disorders | Non-systematic Assessment |
|
| Hospitalization | Renal and urinary disorders | Non-systematic Assessment |
|
| Hospitalization | Surgical and medical procedures | Non-systematic Assessment |
|
| Hospitalization | Vascular disorders | Non-systematic Assessment |
|
| Hospitalization | Injury, poisoning and procedural complications | Non-systematic Assessment |
|
| Back pain | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
|
| Fall | Injury, poisoning and procedural complications | Non-systematic Assessment |
|
| Urinary tract infection | Infections and infestations | Non-systematic Assessment |
|
Not provided
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