Vitamin D Deficiency
Conditions
Keywords
balance, vitamin D, exercise, fall risk
Brief summary
In recent years, skeletal and nonskeletal effects of vitamin D has been studied. One of the effects of it was balance and fall prevention. However, these studies were performed on older patients who had not vitamin D deficiency. This study aimed to evaluate the effect of vitamin D replacement therapy and exercise on balance in 50-70 years-old postmenopausal women.
Interventions
DIETARY_SUPPLEMENTVitamin D
Vitamin D3 50.000 IU/per week, for 8 weeks
OTHERExercise
Core stability, balance exercises
Sponsors
Sultan Abdulhamid Han Training and Research Hospital, Istanbul, Turkey
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Investigator)
Eligibility
Sex/Gender
FEMALE
Age
50 Years to 70 Years
Healthy volunteers
Yes
Inclusion criteria
* 50-70 years-old postmenopausal women * Vitamin D level\<10 ng/ml and Vitamin D level\>30 ng/ml * Independant in daily life * Able to do exercise * Able to read and write in Turkish
Exclusion criteria
* Diabetes mellitus, * Polyneuropathy, * Spinal stenosis, * History of fracture or lower extremity operation, * Rheumatologic diseases, * History of chemotherapy * Cognitive impairment
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Berg Balance Test Assessed After Treatment (8weeks) | After treatment (8 weeks) | 14-item scale designed to measure balance of the older adult in a clinical setting minimum: 0 maximum: 56 A score of 56 indicates functional balance. A score of \< 45 indicates individuals may be at greater risk of falling. |
| Postural Stability Test (Biodex) Assessed at Baseline | Baseline | overall stability index: quantifying the ability to maintain dynamic postural stability The patient's score on this test assesses deviations from center, thus lower index means less instability and better balance. Measures were obtained from 20-sec trials during which participants were asked to maintain an upright standing position on their dominant limb on the unstable surface of the Biodex Stability and Balance System. 0 is the minimum score, but there is no defined maximum score |
| Postural Stability Test (Biodex) Assessed After Treatment (8 Weeks) | After treatment (8 weeks) | overall stability index: quantifying the ability to maintain dynamic postural stability. The patient's score on this test assesses deviations from center, thus a lower score is more desirable than a higher score. Measures were obtained from 20-sec trials during which participants were asked to maintain an upright standing position on their dominant limb on the unstable surface of the Biodex Stability and Balance System 0 is the minimum score, but there is no defined maximum score |
| Berg Balance Test Assessed at Baseline | Baseline | 14-item scale designed to measure balance of the older adult in a clinical setting minimum: 0 maximum: 56 A score of 56 indicates functional balance. A score of \< 45 indicates individuals may be at greater risk of falling. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Fall Risk Assesment Performed at Baseline | Baseline | Biodex fall risk screening test: Patients were instructed to maintain the vertical projection with their center of gravity in the midpoint of the platform 0 is the best possible value, higher score reflects increased risk of falling. But there is no defined maximum score |
| Fall Risk Assesment Performed After Treatment (8 Weeks) | After treatment (8 weeks) | Biodex fall risk screening test: Patients were instructed to maintain the vertical projection with their center of gravity in the midpoint of the platform 0° is the best possible value, higher score reflects increased risk of falling. But there is no defined maximum score. |
| Health Status Assessed at Baseline | Baseline | Notthingham Health Profile: general patient reported outcome measure which measures subjective health status. 38 questions in 6 subareas, with each question assigned a weighted value; the sum of all weighted valuesin a given subarea adds up to 100. Overall score is calculated by summing up 6 subdomian scores. Ovearall minimum: 0 maximum: 600 (6X100) Higher scores reflect worse health status |
| Health Status Assessed After Treatment (8 Weeks) | After treatment (8 weeks) | Notthingham Health Profile: general patient reported outcome measure which measures subjective health status. 38 questions in 6 subareas, with each question assigned a weighted value; the sum of all weighted valuesin a given subarea adds up to 100. Overall score is calculated by summing up 6 subdomian scores. Ovearall minimum: 0 maximum: 600 (6X100) Higher scores reflect worse health status. |
Countries
Turkey (Türkiye)
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Vitamin D<10 ng/ml; Vitamin D Replacement Vitamin D: Vitamin D3 50.000 IU/per week, for 8 weeks | 21 |
| Vitamin D<10 ng/ml; Exercise Exercise: Core stability, balance exercises | 18 |
| Vitamin D<10 ng/ml; Vitamin D Replacement and Exercise Vitamin D: Vitamin D3 50.000 IU/per week, for 8 weeks and Exercise: Core stability, balance exercises | 20 |
| Vitamin D>30ng/ml; Exercise Exercise: Core stability, balance exercises | 40 |
| Total | 99 |
Baseline characteristics
| Characteristic | Vitamin D<10 ng/ml; Vitamin D Replacement | Vitamin D<10 ng/ml; Exercise | Vitamin D<10 ng/ml; Vitamin D Replacement and Exercise | Vitamin D>30ng/ml; Exercise | Total |
|---|---|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 20 Participants | 17 Participants | 19 Participants | 36 Participants | 92 Participants |
| Age, Categorical Between 18 and 65 years | 1 Participants | 1 Participants | 1 Participants | 4 Participants | 7 Participants |
| Age, Continuous | 55.76 years STANDARD_DEVIATION 5.08 | 54.66 years STANDARD_DEVIATION 5.59 | 55.70 years STANDARD_DEVIATION 4.84 | 58.82 years STANDARD_DEVIATION 5.84 | 56.78 years STANDARD_DEVIATION 5.64 |
| Race/Ethnicity, Customized Caucasian | 21 Participants | 18 Participants | 20 Participants | 40 Participants | 99 Participants |
| Region of Enrollment Turkey | 21 participants | 18 participants | 20 participants | 40 participants | 99 participants |
| Sex: Female, Male Female | 21 Participants | 18 Participants | 20 Participants | 40 Participants | 99 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 0 | 0 / 0 | 0 / 0 | 0 / 0 |
| other Total, other adverse events | 0 / 0 | 0 / 0 | 0 / 0 | 0 / 0 |
| serious Total, serious adverse events | 0 / 0 | 0 / 0 | 0 / 0 | 0 / 0 |
Outcome results
Primary
Berg Balance Test Assessed After Treatment (8weeks)
14-item scale designed to measure balance of the older adult in a clinical setting minimum: 0 maximum: 56 A score of 56 indicates functional balance. A score of \< 45 indicates individuals may be at greater risk of falling.
Time frame: After treatment (8 weeks)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Vitamin D<10 ng/ml; Vitamin D Replacement | Berg Balance Test Assessed After Treatment (8weeks) | 53.33 score on a scale | Standard Deviation 2.67 |
| Vitamin D<10 ng/ml; Exercise | Berg Balance Test Assessed After Treatment (8weeks) | 53.55 score on a scale | Standard Deviation 1.78 |
| Vitamin D<10 ng/ml; Vitamin D Replacement and Exercise | Berg Balance Test Assessed After Treatment (8weeks) | 54.25 score on a scale | Standard Deviation 1.37 |
| Vitamin D>30ng/ml; Exercise | Berg Balance Test Assessed After Treatment (8weeks) | 54.27 score on a scale | Standard Deviation 1.96 |
Primary
Berg Balance Test Assessed at Baseline
14-item scale designed to measure balance of the older adult in a clinical setting minimum: 0 maximum: 56 A score of 56 indicates functional balance. A score of \< 45 indicates individuals may be at greater risk of falling.
Time frame: Baseline
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Vitamin D<10 ng/ml; Vitamin D Replacement | Berg Balance Test Assessed at Baseline | 51.52 score on a scale | Standard Deviation 2.94 |
| Vitamin D<10 ng/ml; Exercise | Berg Balance Test Assessed at Baseline | 51.77 score on a scale | Standard Deviation 1.8 |
| Vitamin D<10 ng/ml; Vitamin D Replacement and Exercise | Berg Balance Test Assessed at Baseline | 52.35 score on a scale | Standard Deviation 1.59 |
| Vitamin D>30ng/ml; Exercise | Berg Balance Test Assessed at Baseline | 53.02 score on a scale | Standard Deviation 2.49 |
Primary
Postural Stability Test (Biodex) Assessed After Treatment (8 Weeks)
overall stability index: quantifying the ability to maintain dynamic postural stability. The patient's score on this test assesses deviations from center, thus a lower score is more desirable than a higher score. Measures were obtained from 20-sec trials during which participants were asked to maintain an upright standing position on their dominant limb on the unstable surface of the Biodex Stability and Balance System 0 is the minimum score, but there is no defined maximum score
Time frame: After treatment (8 weeks)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Vitamin D<10 ng/ml; Vitamin D Replacement | Postural Stability Test (Biodex) Assessed After Treatment (8 Weeks) | 1.90 score | Standard Deviation 1.2 |
| Vitamin D<10 ng/ml; Exercise | Postural Stability Test (Biodex) Assessed After Treatment (8 Weeks) | 1.83 score | Standard Deviation 0.83 |
| Vitamin D<10 ng/ml; Vitamin D Replacement and Exercise | Postural Stability Test (Biodex) Assessed After Treatment (8 Weeks) | 1.56 score | Standard Deviation 0.74 |
| Vitamin D>30ng/ml; Exercise | Postural Stability Test (Biodex) Assessed After Treatment (8 Weeks) | 1.43 score | Standard Deviation 0.86 |
Primary
Postural Stability Test (Biodex) Assessed at Baseline
overall stability index: quantifying the ability to maintain dynamic postural stability The patient's score on this test assesses deviations from center, thus lower index means less instability and better balance. Measures were obtained from 20-sec trials during which participants were asked to maintain an upright standing position on their dominant limb on the unstable surface of the Biodex Stability and Balance System. 0 is the minimum score, but there is no defined maximum score
Time frame: Baseline
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Vitamin D<10 ng/ml; Vitamin D Replacement | Postural Stability Test (Biodex) Assessed at Baseline | 2.25 score | Standard Deviation 1.27 |
| Vitamin D<10 ng/ml; Exercise | Postural Stability Test (Biodex) Assessed at Baseline | 2.30 score | Standard Deviation 0.97 |
| Vitamin D<10 ng/ml; Vitamin D Replacement and Exercise | Postural Stability Test (Biodex) Assessed at Baseline | 2.18 score | Standard Deviation 1.01 |
| Vitamin D>30ng/ml; Exercise | Postural Stability Test (Biodex) Assessed at Baseline | 1.97 score | Standard Deviation 1.02 |
Secondary
Fall Risk Assesment Performed After Treatment (8 Weeks)
Biodex fall risk screening test: Patients were instructed to maintain the vertical projection with their center of gravity in the midpoint of the platform 0° is the best possible value, higher score reflects increased risk of falling. But there is no defined maximum score.
Time frame: After treatment (8 weeks)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Vitamin D<10 ng/ml; Vitamin D Replacement | Fall Risk Assesment Performed After Treatment (8 Weeks) | 1.40 score | Standard Deviation 0.74 |
| Vitamin D<10 ng/ml; Exercise | Fall Risk Assesment Performed After Treatment (8 Weeks) | 1.57 score | Standard Deviation 0.69 |
| Vitamin D<10 ng/ml; Vitamin D Replacement and Exercise | Fall Risk Assesment Performed After Treatment (8 Weeks) | 1.35 score | Standard Deviation 0.57 |
| Vitamin D>30ng/ml; Exercise | Fall Risk Assesment Performed After Treatment (8 Weeks) | 1.81 score | Standard Deviation 2.79 |
Secondary
Fall Risk Assesment Performed at Baseline
Biodex fall risk screening test: Patients were instructed to maintain the vertical projection with their center of gravity in the midpoint of the platform 0 is the best possible value, higher score reflects increased risk of falling. But there is no defined maximum score
Time frame: Baseline
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Vitamin D<10 ng/ml; Vitamin D Replacement | Fall Risk Assesment Performed at Baseline | 1.69 score | Standard Deviation 1.08 |
| Vitamin D<10 ng/ml; Exercise | Fall Risk Assesment Performed at Baseline | 1.96 score | Standard Deviation 0.94 |
| Vitamin D<10 ng/ml; Vitamin D Replacement and Exercise | Fall Risk Assesment Performed at Baseline | 1.90 score | Standard Deviation 0.98 |
| Vitamin D>30ng/ml; Exercise | Fall Risk Assesment Performed at Baseline | 1.71 score | Standard Deviation 0.98 |
Secondary
Health Status Assessed After Treatment (8 Weeks)
Notthingham Health Profile: general patient reported outcome measure which measures subjective health status. 38 questions in 6 subareas, with each question assigned a weighted value; the sum of all weighted valuesin a given subarea adds up to 100. Overall score is calculated by summing up 6 subdomian scores. Ovearall minimum: 0 maximum: 600 (6X100) Higher scores reflect worse health status.
Time frame: After treatment (8 weeks)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Vitamin D<10 ng/ml; Vitamin D Replacement | Health Status Assessed After Treatment (8 Weeks) | 170.19 score on a scale | Standard Deviation 120.24 |
| Vitamin D<10 ng/ml; Exercise | Health Status Assessed After Treatment (8 Weeks) | 158.23 score on a scale | Standard Deviation 145.94 |
| Vitamin D<10 ng/ml; Vitamin D Replacement and Exercise | Health Status Assessed After Treatment (8 Weeks) | 171.98 score on a scale | Standard Deviation 108.18 |
| Vitamin D>30ng/ml; Exercise | Health Status Assessed After Treatment (8 Weeks) | 119.30 score on a scale | Standard Deviation 97.04 |
Secondary
Health Status Assessed at Baseline
Notthingham Health Profile: general patient reported outcome measure which measures subjective health status. 38 questions in 6 subareas, with each question assigned a weighted value; the sum of all weighted valuesin a given subarea adds up to 100. Overall score is calculated by summing up 6 subdomian scores. Ovearall minimum: 0 maximum: 600 (6X100) Higher scores reflect worse health status
Time frame: Baseline
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Vitamin D<10 ng/ml; Vitamin D Replacement | Health Status Assessed at Baseline | 263.35 score on a scale | Standard Deviation 143.52 |
| Vitamin D<10 ng/ml; Exercise | Health Status Assessed at Baseline | 212.81 score on a scale | Standard Deviation 137.78 |
| Vitamin D<10 ng/ml; Vitamin D Replacement and Exercise | Health Status Assessed at Baseline | 229.98 score on a scale | Standard Deviation 119.31 |
| Vitamin D>30ng/ml; Exercise | Health Status Assessed at Baseline | 161.10 score on a scale | Standard Deviation 109.88 |