Trial Outcomes & Findings for The Effect of Vitamin D and Exercise on Balance in Postmenopausal Women (NCT NCT03608488)

Results Overview

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

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

110 participants

Primary outcome timeframe

Baseline

Results posted on

2020-07-01

Participant Flow

Participant milestones

Participant milestones
Measure	Vitamin D<10 ng/ml; Vitamin D Replacement Vitamin D: Vitamin D3 50.000 IU/per week, for 8 weeks	Vitamin D<10 ng/ml; Exercise Exercise: Core stability, balance exercises	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	Vitamin D>30ng/ml; Exercise Exercise: Core stability, balance exercises
Overall Study STARTED	22	21	22	45
Overall Study COMPLETED	21	18	20	40
Overall Study NOT COMPLETED	1	3	2	5

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

The Effect of Vitamin D and Exercise on Balance in Postmenopausal Women

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Vitamin D<10 ng/ml; Vitamin D Replacement n=21 Participants Vitamin D: Vitamin D3 50.000 IU/per week, for 8 weeks	Vitamin D<10 ng/ml; Exercise n=18 Participants Exercise: Core stability, balance exercises	Vitamin D<10 ng/ml; Vitamin D Replacement and Exercise n=20 Participants Vitamin D: Vitamin D3 50.000 IU/per week, for 8 weeks and Exercise: Core stability, balance exercises	Vitamin D>30ng/ml; Exercise n=40 Participants Exercise: Core stability, balance exercises	Total n=99 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants
Age, Categorical Between 18 and 65 years	1 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants	4 Participants n=4 Participants	7 Participants n=21 Participants
Age, Categorical >=65 years	20 Participants n=5 Participants	17 Participants n=7 Participants	19 Participants n=5 Participants	36 Participants n=4 Participants	92 Participants n=21 Participants
Age, Continuous	55.76 years STANDARD_DEVIATION 5.08 • n=5 Participants	54.66 years STANDARD_DEVIATION 5.59 • n=7 Participants	55.70 years STANDARD_DEVIATION 4.84 • n=5 Participants	58.82 years STANDARD_DEVIATION 5.84 • n=4 Participants	56.78 years STANDARD_DEVIATION 5.64 • n=21 Participants
Sex: Female, Male Female	21 Participants n=5 Participants	18 Participants n=7 Participants	20 Participants n=5 Participants	40 Participants n=4 Participants	99 Participants n=21 Participants
Sex: Female, Male Male	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants
Race/Ethnicity, Customized Caucasian	21 Participants n=5 Participants	18 Participants n=7 Participants	20 Participants n=5 Participants	40 Participants n=4 Participants	99 Participants n=21 Participants
Region of Enrollment Turkey	21 participants n=5 Participants	18 participants n=7 Participants	20 participants n=5 Participants	40 participants n=4 Participants	99 participants n=21 Participants

PRIMARY outcome

Timeframe: 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

Outcome measures

Outcome measures
Measure	Vitamin D<10 ng/ml; Vitamin D Replacement n=21 Participants Vitamin D: Vitamin D3 50.000 IU/per week, for 8 weeks	Vitamin D<10 ng/ml; Exercise n=18 Participants Exercise: Core stability, balance exercises	Vitamin D<10 ng/ml; Vitamin D Replacement and Exercise n=20 Participants Vitamin D: Vitamin D3 50.000 IU/per week, for 8 weeks and Exercise: Core stability, balance exercises	Vitamin D>30ng/ml; Exercise n=40 Participants Exercise: Core stability, balance exercises
Postural Stability Test (Biodex) Assessed at Baseline	2.25 score Standard Deviation 1.27	2.30 score Standard Deviation 0.97	2.18 score Standard Deviation 1.01	1.97 score Standard Deviation 1.02

PRIMARY outcome

Timeframe: 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

Outcome measures

Outcome measures
Measure	Vitamin D<10 ng/ml; Vitamin D Replacement n=21 Participants Vitamin D: Vitamin D3 50.000 IU/per week, for 8 weeks	Vitamin D<10 ng/ml; Exercise n=18 Participants Exercise: Core stability, balance exercises	Vitamin D<10 ng/ml; Vitamin D Replacement and Exercise n=20 Participants Vitamin D: Vitamin D3 50.000 IU/per week, for 8 weeks and Exercise: Core stability, balance exercises	Vitamin D>30ng/ml; Exercise n=40 Participants Exercise: Core stability, balance exercises
Postural Stability Test (Biodex) Assessed After Treatment (8 Weeks)	1.90 score Standard Deviation 1.20	1.83 score Standard Deviation 0.83	1.56 score Standard Deviation 0.74	1.43 score Standard Deviation 0.86

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Vitamin D<10 ng/ml; Vitamin D Replacement n=21 Participants Vitamin D: Vitamin D3 50.000 IU/per week, for 8 weeks	Vitamin D<10 ng/ml; Exercise n=18 Participants Exercise: Core stability, balance exercises	Vitamin D<10 ng/ml; Vitamin D Replacement and Exercise n=20 Participants Vitamin D: Vitamin D3 50.000 IU/per week, for 8 weeks and Exercise: Core stability, balance exercises	Vitamin D>30ng/ml; Exercise n=40 Participants Exercise: Core stability, balance exercises
Berg Balance Test Assessed at Baseline	51.52 score on a scale Standard Deviation 2.94	51.77 score on a scale Standard Deviation 1.80	52.35 score on a scale Standard Deviation 1.59	53.02 score on a scale Standard Deviation 2.49

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Vitamin D<10 ng/ml; Vitamin D Replacement n=21 Participants Vitamin D: Vitamin D3 50.000 IU/per week, for 8 weeks	Vitamin D<10 ng/ml; Exercise n=18 Participants Exercise: Core stability, balance exercises	Vitamin D<10 ng/ml; Vitamin D Replacement and Exercise n=20 Participants Vitamin D: Vitamin D3 50.000 IU/per week, for 8 weeks and Exercise: Core stability, balance exercises	Vitamin D>30ng/ml; Exercise n=40 Participants Exercise: Core stability, balance exercises
Berg Balance Test Assessed After Treatment (8weeks)	53.33 score on a scale Standard Deviation 2.67	53.55 score on a scale Standard Deviation 1.78	54.25 score on a scale Standard Deviation 1.37	54.27 score on a scale Standard Deviation 1.96

SECONDARY outcome

Timeframe: 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

Outcome measures

Outcome measures
Measure	Vitamin D<10 ng/ml; Vitamin D Replacement n=21 Participants Vitamin D: Vitamin D3 50.000 IU/per week, for 8 weeks	Vitamin D<10 ng/ml; Exercise n=18 Participants Exercise: Core stability, balance exercises	Vitamin D<10 ng/ml; Vitamin D Replacement and Exercise n=20 Participants Vitamin D: Vitamin D3 50.000 IU/per week, for 8 weeks and Exercise: Core stability, balance exercises	Vitamin D>30ng/ml; Exercise n=40 Participants Exercise: Core stability, balance exercises
Fall Risk Assesment Performed at Baseline	1.69 score Standard Deviation 1.08	1.96 score Standard Deviation 0.94	1.90 score Standard Deviation 0.98	1.71 score Standard Deviation 0.98

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Vitamin D<10 ng/ml; Vitamin D Replacement n=21 Participants Vitamin D: Vitamin D3 50.000 IU/per week, for 8 weeks	Vitamin D<10 ng/ml; Exercise n=18 Participants Exercise: Core stability, balance exercises	Vitamin D<10 ng/ml; Vitamin D Replacement and Exercise n=20 Participants Vitamin D: Vitamin D3 50.000 IU/per week, for 8 weeks and Exercise: Core stability, balance exercises	Vitamin D>30ng/ml; Exercise n=40 Participants Exercise: Core stability, balance exercises
Fall Risk Assesment Performed After Treatment (8 Weeks)	1.40 score Standard Deviation 0.74	1.57 score Standard Deviation 0.69	1.35 score Standard Deviation 0.57	1.81 score Standard Deviation 2.79

SECONDARY outcome

Timeframe: 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

Outcome measures

Outcome measures
Measure	Vitamin D<10 ng/ml; Vitamin D Replacement n=21 Participants Vitamin D: Vitamin D3 50.000 IU/per week, for 8 weeks	Vitamin D<10 ng/ml; Exercise n=18 Participants Exercise: Core stability, balance exercises	Vitamin D<10 ng/ml; Vitamin D Replacement and Exercise n=20 Participants Vitamin D: Vitamin D3 50.000 IU/per week, for 8 weeks and Exercise: Core stability, balance exercises	Vitamin D>30ng/ml; Exercise n=40 Participants Exercise: Core stability, balance exercises
Health Status Assessed at Baseline	263.35 score on a scale Standard Deviation 143.52	212.81 score on a scale Standard Deviation 137.78	229.98 score on a scale Standard Deviation 119.31	161.10 score on a scale Standard Deviation 109.88

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Vitamin D<10 ng/ml; Vitamin D Replacement n=21 Participants Vitamin D: Vitamin D3 50.000 IU/per week, for 8 weeks	Vitamin D<10 ng/ml; Exercise n=18 Participants Exercise: Core stability, balance exercises	Vitamin D<10 ng/ml; Vitamin D Replacement and Exercise n=20 Participants Vitamin D: Vitamin D3 50.000 IU/per week, for 8 weeks and Exercise: Core stability, balance exercises	Vitamin D>30ng/ml; Exercise n=40 Participants Exercise: Core stability, balance exercises
Health Status Assessed After Treatment (8 Weeks)	170.19 score on a scale Standard Deviation 120.24	158.23 score on a scale Standard Deviation 145.94	171.98 score on a scale Standard Deviation 108.18	119.30 score on a scale Standard Deviation 97.04

Adverse Events

Vitamin D<10 ng/ml; Vitamin D Replacement

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Vitamin D<10 ng/ml; Exercise

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Vitamin D<10 ng/ml; Vitamin D Replacement and Exercise

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Vitamin D>30ng/ml; Exercise

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Tugba OZsoy-Unubol

SultanAbdulhamid

Phone: +905074583382

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place