An interventional study of Vitamin D and Exercise in Vitamin D Deficiency, sponsored by Sultan Abdulhamid Han Training and Research Hospital, Istanbul, Turkey. Completed at 1 site in Turkey. Open to female participants aged 50 Years to 70 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2020-07-01.
Sponsored by Sultan Abdulhamid Han Training and Research Hospital, Istanbul, Turkey · Not applicable, Interventional, and Prevention
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.
772 studies on the registry are indexed under Vitamin D Deficiency; 61 are open to participants now.
This study's enrollment of 110 is above the median of 77 across 564 interventional studies indexed under Vitamin D Deficiency.
Browse Vitamin D Deficiency studies →Sultan Abdulhamid Han Training and Research Hospital, Istanbul, Turkey is the lead sponsor of 104 studies on the registry; 28 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Vitamin D replacement (50.000 IU/per week, for 8 weeks)
Dietary Supplement: Vitamin D
Vitamin D replacement (50.000 IU/per week, for 8 weeks) and Core and balance exercises for 8 weeks.
Dietary Supplement: Vitamin D
Core and balance exercises for 8 weeks.
Other: Exercise
Core and balance exercises for 8 weeks.
Other: Exercise
Vitamin D3 50.000 IU/per week, for 8 weeks
Also known as: exercise
Core stability, balance exercises
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
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)
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
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)
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
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)
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
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)
| Milestone | 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 |
|---|---|---|---|---|
| Started | 22 | 21 | 22 | 45 |
| Completed | 21 | 18 | 20 | 40 |
| Not completed | 1 | 3 | 2 | 5 |
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
| score | 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 |
|---|---|---|---|---|
| Postural Stability Test (Biodex) Assessed at Baseline | 2.25 ± 1.27 | 2.30 ± 0.97 | 2.18 ± 1.01 | 1.97 ± 1.02 |
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
| score | 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 |
|---|---|---|---|---|
| Postural Stability Test (Biodex) Assessed After Treatment (8 Weeks) | 1.90 ± 1.20 | 1.83 ± 0.83 | 1.56 ± 0.74 | 1.43 ± 0.86 |
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.
| score on a scale | 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 |
|---|---|---|---|---|
| Berg Balance Test Assessed at Baseline | 51.52 ± 2.94 | 51.77 ± 1.80 | 52.35 ± 1.59 | 53.02 ± 2.49 |
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.
| score on a scale | 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 |
|---|---|---|---|---|
| Berg Balance Test Assessed After Treatment (8weeks) | 53.33 ± 2.67 | 53.55 ± 1.78 | 54.25 ± 1.37 | 54.27 ± 1.96 |
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
| score | 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 |
|---|---|---|---|---|
| Fall Risk Assesment Performed at Baseline | 1.69 ± 1.08 | 1.96 ± 0.94 | 1.90 ± 0.98 | 1.71 ± 0.98 |
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.
| score | 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 |
|---|---|---|---|---|
| Fall Risk Assesment Performed After Treatment (8 Weeks) | 1.40 ± 0.74 | 1.57 ± 0.69 | 1.35 ± 0.57 | 1.81 ± 2.79 |
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
| score on a scale | 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 |
|---|---|---|---|---|
| Health Status Assessed at Baseline | 263.35 ± 143.52 | 212.81 ± 137.78 | 229.98 ± 119.31 | 161.10 ± 109.88 |
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.
| score on a scale | 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 |
|---|---|---|---|---|
| Health Status Assessed After Treatment (8 Weeks) | 170.19 ± 120.24 | 158.23 ± 145.94 | 171.98 ± 108.18 | 119.30 ± 97.04 |
Collected over Adverse Events were not monitored/assessed. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| 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 | — | — | — |
| Age, Categorical(Participants) | 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 |
|---|---|---|---|---|---|
| <=18 years | 0 | 0 | 0 | 0 | 0 |
| Between 18 and 65 years | 1 | 1 | 1 | 4 | 7 |
| >=65 years | 20 | 17 | 19 | 36 | 92 |
| Age, Continuous(years) | 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 |
|---|---|---|---|---|---|
| Mean | 55.76 ± 5.08 | 54.66 ± 5.59 | 55.70 ± 4.84 | 58.82 ± 5.84 | 56.78 ± 5.64 |
| Sex: Female, Male(Participants) | 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 |
|---|---|---|---|---|---|
| Female | 21 | 18 | 20 | 40 | 99 |
| Male | 0 | 0 | 0 | 0 | 0 |
| Race/Ethnicity, Customized(Participants) | 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 |
|---|---|---|---|---|---|
| Caucasian | 21 | 18 | 20 | 40 | 99 |
| Region of Enrollment(participants) | 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 |
|---|---|---|---|---|---|
| Turkey | 21 | 18 | 20 | 40 | 99 |
Documents are hosted by the registry — open the source record to download them.
Plan to share: No
This study is completed, as verified in Jun 2020. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Sultan Abdulhamid Han Training and Research Hospital, Istanbul, Turkey