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

NCT ID: NCT03608488

Last Updated: 2020-07-01

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

110 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-08-06

Study Completion Date

2019-07-12

Brief Summary

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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.

Detailed Description

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Conditions

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Vitamin D Deficiency

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Investigators

Study Groups

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Vitamin D<10 ng/ml; Vitamin D replacement

Vitamin D replacement (50.000 IU/per week, for 8 weeks)

Group Type EXPERIMENTAL

Vitamin D

Intervention Type DIETARY_SUPPLEMENT

Vitamin D3 50.000 IU/per week, for 8 weeks

Vitamin D<10 ng/ml; Vitamin D replacement and exercise

Vitamin D replacement (50.000 IU/per week, for 8 weeks) and Core and balance exercises for 8 weeks.

Group Type EXPERIMENTAL

Vitamin D

Intervention Type DIETARY_SUPPLEMENT

Vitamin D3 50.000 IU/per week, for 8 weeks

Vitamin D<10 ng/ml; exercise

Core and balance exercises for 8 weeks.

Group Type EXPERIMENTAL

Exercise

Intervention Type OTHER

Core stability, balance exercises

Vitamin D>30ng/ml; exercise

Core and balance exercises for 8 weeks.

Group Type ACTIVE_COMPARATOR

Exercise

Intervention Type OTHER

Core stability, balance exercises

Interventions

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Vitamin D

Vitamin D3 50.000 IU/per week, for 8 weeks

Intervention Type DIETARY_SUPPLEMENT

Exercise

Core stability, balance exercises

Intervention Type OTHER

Other Intervention Names

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exercise

Eligibility Criteria

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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
Minimum Eligible Age

50 Years

Maximum Eligible Age

70 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Sultan Abdulhamid Han Training and Research Hospital, Istanbul, Turkey

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Tugba Ozsoy-Unubol, MD

Role: PRINCIPAL_INVESTIGATOR

Sultan Abdulhamid Han Training and Research Hospital

Locations

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Sultan Abdulhamid Han Training and Research Hospital

Istanbul, , Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

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Tugbaozsoy

Identifier Type: -

Identifier Source: org_study_id

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