Vitamin D DeficiencyNCT03608488

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

A study testing Vitamin D and Exercise in people with Vitamin D Deficiency, run by Sultan Abdulhamid Han Training and Research Hospital, Istanbul, Turkey at 1 site in Turkey (Türkiye).

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial summary

Who is it for?: Ages 50 to 70 years, women onlyHealthy volunteers can take part
Conditions the study is for: Vitamin D Deficiency
What is being tested?: Vitamin D and Exercise
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 110 participants
Where: 1 siteTurkey (Türkiye)
Study dates: 6 Aug 2018to 12 Jul 2019
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 50 to 70 years
Women only
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

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

Who cannot join

Diabetes mellitus,
Polyneuropathy,
Spinal stenosis,
History of fracture or lower extremity operation,
Rheumatologic diseases,
History of chemotherapy
Cognitive impairment

Trial locations and contacts

1 site in 1 country.

Turkey (Türkiye)1 site

Sultan Abdulhamid Han Training and Research Hospital
Istanbul

Other trials in Turkey (Türkiye)

About this study

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.

Conditions: Vitamin D Deficiency
Being tested: Vitamin D, Exercise
Keywords: balance, vitamin D, exercise, fall risk
Medical subject headings: Vitamin D Deficiency, Motor Activity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Vitamin DDietary supplement
Also called exercise
Vitamin D3 50.000 IU/per week, for 8 weeks
ExerciseOther
Core stability, balance exercises

Study groups in NCT03608488
Study group	Role	What they receive
Vitamin D<10 ng/ml; Vitamin D replacement	Experimental	Vitamin D replacement (50.000 IU/per week, for 8 weeks) Receives: Dietary Supplement: Vitamin D
Vitamin D<10 ng/ml; Vitamin D replacement and exercise	Experimental	Vitamin D replacement (50.000 IU/per week, for 8 weeks) and Core and balance exercises for 8 weeks. Receives: Dietary Supplement: Vitamin D
Vitamin D<10 ng/ml; exercise	Experimental	Core and balance exercises for 8 weeks. Receives: Other: Exercise
Vitamin D>30ng/ml; exercise	Active comparator	Core and balance exercises for 8 weeks. Receives: Other: Exercise

What is being measured

The primary outcome is the main question the study is designed to answer.

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
Measured: 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
Measured: 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.
Measured: 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.
Measured: After treatment (8 weeks)

Secondary outcomes (4)

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
Measured: 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.
Measured: 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
Measured: 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.
Measured: After treatment (8 weeks)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

6 Aug 201812 Jul 2019

First posted1 Aug 2018
Study start6 Aug 2018
Primary completion12 Jul 2019
Study completion12 Jul 2019

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Vitamin D DeficiencyStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind
Who is masked: Investigator
Enrolment: 110 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03608488
Sponsor's protocol ID: Tugbaozsoy
Status last verified: Jun 2020
First submitted: 4 Jul 2018
Last updated: 1 Jul 2020
Results posted: Yes, on ClinicalTrials.gov
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

RecruitingPhase 1/2
A First-in-human Study of KK8123 in Adults With X-linked Hypophosphatemia
X-linked Hypophosphatemia
Not yet recruitingPhase 2
REducing Systemic Inflammation With LOw-dose Colchicine to ImproVE Cardiovascular Calcification in Chronic Kidney Disease: A Pilot Randomized Open-Label Trial
Chronic Kidney Disease Mineral and Bone Disorder, Cognitive Function
Recruiting
Role of Vitamin D Supplementation in Children With Irritable Bowel Syndrome
Irritable Bowel Syndrome (IBS), Vitamin D Deficiency
RecruitingObservational study
Post Marketing Surveillance Study to Observe Safety and Effectiveness of CRYSVITA® in S. Korean Patients
FGF23-related Hypophosphataemic Rickets and Osteomalacia
Not yet recruiting
Effect of Vitamin D Supplementation Added to Iron Therapy in Children With Iron Deficiency Anemia
Iron Deficiency Anemia

All Vitamin D Deficiency trials

Study at a glance

From the registry record, last updated by the sponsor on 1 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: The Effect of Vitamin D and Exercise on Balance in Postmenopausal Women
ClinicalTrials.gov ID: NCT03608488
Acronym / sponsor ID: Tugbaozsoy
Conditions: Vitamin D Deficiency
Keywords: balance, vitamin D, exercise, fall risk
Study type: Interventional
Recruitment status: Completed
Enrolment: 110 participants (actual)
Lead sponsor: Sultan Abdulhamid Han Training and Research Hospital, Istanbul, TurkeyUniversity, hospital or other
Study start: 6 Aug 2018 (actual)
Primary completion: 12 Jul 2019 (actual)
Study completion: 12 Jul 2019 (actual)
First posted: 1 Aug 2018 (actual)
Results: Posted 27 Feb 2020

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind (investigator)
Number of arms: 4

Arm	Type	Receives
Vitamin D<10 ng/ml; Vitamin D replacement	Experimental	Dietary Supplement: Vitamin DVitamin D replacement (50.000 IU/per week, for 8 weeks)
Vitamin D<10 ng/ml; Vitamin D replacement and exercise	Experimental	Dietary Supplement: Vitamin DVitamin D replacement (50.000 IU/per week, for 8 weeks) and Core and balance exercises for 8 weeks.
Vitamin D<10 ng/ml; exercise	Experimental	Other: ExerciseCore and balance exercises for 8 weeks.
Vitamin D>30ng/ml; exercise	Active comparator	Other: ExerciseCore and balance exercises for 8 weeks.

Who may qualify

Ages: 50 to 70 years
Sex: Female only
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (5 listed)

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

Key exclusion criteria (7 listed)

Diabetes mellitus,
Polyneuropathy,
Spinal stenosis,
History of fracture or lower extremity operation,
Rheumatologic diseases,

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Vitamin DAlso: exerciseVitamin D3 50.000 IU/per week, for 8 weeks	Dietary supplement	Vitamin D<10 ng/ml; Vitamin D replacement, Vitamin D<10 ng/ml; Vitamin D replacement and exercise
ExerciseCore stability, balance exercises	Other	Vitamin D<10 ng/ml; exercise, Vitamin D>30ng/ml; exercise

Primary outcome

Postural Stability Test (Biodex) Assessed at Baseline
Time frame: 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)
Time frame: 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
Time frame: 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.
Berg Balance Test Assessed After Treatment (8weeks)
Time frame: 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.

4 secondary outcomes

Fall Risk Assesment Performed at Baseline
Time frame: Baseline
Fall Risk Assesment Performed After Treatment (8 Weeks)
Time frame: After treatment (8 weeks)
Health Status Assessed at Baseline
Time frame: Baseline
Health Status Assessed After Treatment (8 Weeks)
Time frame: After treatment (8 weeks)

Results and safety

Results posted to the registry on 27 Feb 2020, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Vitamin D<10 ng/ml; Vitamin D Replacement	22	21
Vitamin D<10 ng/ml; Exercise	21	18
Vitamin D<10 ng/ml; Vitamin D Replacement and Exercise	22	20
Vitamin D>30ng/ml; Exercise	45	40

Primary outcome: Postural Stability Test (Biodex) Assessed at Baseline

Time frame: Baseline. Mean (Standard Deviation). Unit: score

Measure	Vitamin D<10 ng/ml; Vitamin D Replacement n = 21	Vitamin D<10 ng/ml; Exercise n = 18	Vitamin D<10 ng/ml; Vitamin D Replacement and Exercise n = 20	Vitamin D>30ng/ml; Exercise n = 40
Value	2.25 (1.27)	2.30 (0.97)	2.18 (1.01)	1.97 (1.02)

Primary outcome: Postural Stability Test (Biodex) Assessed After Treatment (8 Weeks)

Time frame: After treatment (8 weeks). Mean (Standard Deviation). Unit: score

Measure	Vitamin D<10 ng/ml; Vitamin D Replacement n = 21	Vitamin D<10 ng/ml; Exercise n = 18	Vitamin D<10 ng/ml; Vitamin D Replacement and Exercise n = 20	Vitamin D>30ng/ml; Exercise n = 40
Value	1.90 (1.20)	1.83 (0.83)	1.56 (0.74)	1.43 (0.86)

Primary outcome: Berg Balance Test Assessed at Baseline

Time frame: Baseline. Mean (Standard Deviation). Unit: score on a scale

Measure	Vitamin D<10 ng/ml; Vitamin D Replacement n = 21	Vitamin D<10 ng/ml; Exercise n = 18	Vitamin D<10 ng/ml; Vitamin D Replacement and Exercise n = 20	Vitamin D>30ng/ml; Exercise n = 40
Value	51.52 (2.94)	51.77 (1.80)	52.35 (1.59)	53.02 (2.49)

Primary outcome: Berg Balance Test Assessed After Treatment (8weeks)

Time frame: After treatment (8 weeks). Mean (Standard Deviation). Unit: score on a scale

Measure	Vitamin D<10 ng/ml; Vitamin D Replacement n = 21	Vitamin D<10 ng/ml; Exercise n = 18	Vitamin D<10 ng/ml; Vitamin D Replacement and Exercise n = 20	Vitamin D>30ng/ml; Exercise n = 40
Value	53.33 (2.67)	53.55 (1.78)	54.25 (1.37)	54.27 (1.96)

4 secondary outcomes are reported in the full results.

Adverse events

Time frame: Adverse Events were not monitored/assessed. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events
Vitamin D<10 ng/ml; Vitamin D Replacement	0 of 0	0 of 0
Vitamin D<10 ng/ml; Exercise	0 of 0	0 of 0
Vitamin D<10 ng/ml; Vitamin D Replacement and Exercise	0 of 0	0 of 0
Vitamin D>30ng/ml; Exercise	0 of 0	0 of 0

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 1 Jul 2020.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: No

Related trials for Vitamin D Deficiency

RecruitingPhase 1/2
A First-in-human Study of KK8123 in Adults With X-linked Hypophosphatemia
X-linked Hypophosphatemia
Not yet recruitingPhase 2
REducing Systemic Inflammation With LOw-dose Colchicine to ImproVE Cardiovascular Calcification in Chronic Kidney Disease: A Pilot Randomized Open-Label Trial
Chronic Kidney Disease Mineral and Bone Disorder, Cognitive Function
Recruiting
Role of Vitamin D Supplementation in Children With Irritable Bowel Syndrome
Irritable Bowel Syndrome (IBS), Vitamin D Deficiency
RecruitingObservational study
Post Marketing Surveillance Study to Observe Safety and Effectiveness of CRYSVITA® in S. Korean Patients
FGF23-related Hypophosphataemic Rickets and Osteomalacia
Not yet recruiting
Effect of Vitamin D Supplementation Added to Iron Therapy in Children With Iron Deficiency Anemia
Iron Deficiency Anemia

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Tugba Ozsoy-Unubol, MD principal investigator

Sultan Abdulhamid Han Training and Research Hospital

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Vitamin D and Exercise in people with Vitamin D Deficiency, run by Sultan Abdulhamid Han Training and Research Hospital, Istanbul, Turkey at 1 site in Turkey (Türkiye).

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 1 Jul 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 27 Feb 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Postural Stability Test (Biodex) Assessed at Baseline (time frame: Baseline). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03608488.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Jul 2020.