Vitamin D DeficiencyBMR-VITDNCT07435935
Bone Myoregulation Reflex and Postural Control in Vitamin D Deficiency
An observational study of Vitamin D Deficiency, run by Istanbul Physical Medicine Rehabilitation Training and Research Hospital at 1 site in Turkey (Türkiye).
Trial summary
This observational study aims to investigate the relationship between vitamin D deficiency, postural stability, and neuromuscular control mechanisms in adults. The study will compare individuals with vitamin D deficiency and healthy controls. Read more about this study
- Who is it for?
- Ages 20 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Vitamin D Deficiency
- How many people
- 24 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 5 Mar 2026to 25 Oct 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 20 to 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: Adults aged 20 to 40 years recruited from the outpatient clinics of Istanbul Physical Medicine and Rehabilitation Training and Research Hospital. Participants will include individuals with laboratory-confirmed vitamin D deficiency and healthy volunteers with normal vitamin D status.
Who may be able to join
- Age 20 to 40 years.
- Ability to provide written informed consent.
- Vitamin D deficiency group: serum 25-hydroxyvitamin D level <10 ng/mL measured within the last 3 months (routine clinical testing).
- Healthy control group: normal vitamin D status based on routine clinical testing within the last 3 months.
- No use of vitamin D or calcium supplementation within the last 3 months.
Who cannot join
- Known metabolic bone disease other than vitamin D deficiency.
- Neurological disorder (central or peripheral) or neuromuscular disease.
- History of lower-limb surgery, fracture, or prosthesis affecting standing balance.
- Vestibular disorder.
- BMI >30 kg/m2.
- Active malignancy.
- Severe psychiatric disorder.
- Skin condition preventing placement of surface EMG electrodes.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Istanbul Physical Medicine and Rehabilitation Training and Research Hospital
Istanbul, 34186
About this study
Official title: Investigation of Postural Stability and Load-Sensitive Neuromuscular Control Mechanisms in Vitamin D Deficiency
This observational study aims to investigate the relationship between vitamin D deficiency, postural stability, and neuromuscular control mechanisms in adults. The study will compare individuals with vitamin D deficiency and healthy controls.
Participants will undergo a single-session evaluation including surface electromyography and postural stability assessments during standing tasks under different loading and vibration conditions. No invasive procedures, medications, or blood sampling will be performed. Previously obtained routine laboratory results will be used for vitamin D status.
The study is designed to improve understanding of neuromuscular responses associated with vitamin D deficiency and to contribute to future rehabilitation strategies.
Read the detailed description
This single-center observational study is designed to evaluate postural stability and load-sensitive neuromuscular control mechanisms in adults with vitamin D deficiency.
Participants will be divided into two groups based on their vitamin D status: individuals with vitamin D deficiency and healthy controls. Vitamin D levels will be determined using previously obtained routine laboratory test results. No additional blood sampling will be performed for this study.
All participants will undergo a standardized assessment protocol in a single session. Surface electromyography will be used to record muscle activity during standing tasks under different postural and loading conditions. Measurements will be performed during single-leg and double-leg stance, with and without vibration stimulation. The procedures are non-invasive and do not involve any pharmacological intervention.
Postural stability parameters and neuromuscular response variables will be analyzed and compared between groups. The primary objective is to identify potential differences in reflex modulation and postural control associated with vitamin D deficiency.
The study aims to provide objective data on neuromuscular adaptations related to vitamin D status and to support future research in rehabilitation and balance training.
- Conditions
- Vitamin D Deficiency
- Keywords
- Vitamin D Deficiency, Postural Stability, Balance Control, Neuromuscular Control, Surface Electromyography, Reflex Modulation, Bone Myoregulation Reflex, Standing Balance, Rehabilitation Research, Postural Sway
- Medical subject headings
- Vitamin D Deficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Vitamin D Deficiency Group | Participants with laboratory-confirmed vitamin D deficiency based on routine clinical test results. All participants will undergo standardized non-invasive postural stability and surface electromyography assessments in a single session. | |
| Healthy Control Group | Participants with normal vitamin D status based on routine clinical test results and no history of balance or neuromuscular disorders. All participants will undergo standardized non-invasive postural stability and surface electromyography assessments in a single session. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postural Stability Parameters
Postural stability parameters measured during single-leg and double-leg standing using force platform and surface electromyography, including postural sway and neuromuscular response variables.
Measured: Single assessment session (baseline)
Secondary outcomes (2)
Neuromuscular Reflex and Muscle Activation Patterns
Surface electromyography-derived muscle activation and reflex modulation parameters recorded under different loading and vibration conditions.
Measured: Single assessment session (baseline)
Effect of Loading and Vibration on Postural Control
Changes in postural stability and neuromuscular responses under loaded and unloaded conditions with and without vibration.
Measured: Single assessment session (baseline)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Feb 2026
- Study start5 Mar 2026
- Primary completion25 Sep 2026
- Study completion25 Oct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 24 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Istanbul Physical Medicine Rehabilitation Training and Research Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Selim Sezikli, Istanbul Physical Medicine Rehabilitation Training and Research Hospital
- Investigators
- Selim Sezikli, MD, Principal investigator, Istanbul Physical Medicine and Rehabilitation Training and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07435935
- Sponsor's protocol ID
- OSTEOMALACIA-BMR-2026
- Acronym
- BMR-VITD
- Status last verified
- Feb 2026
- First submitted
- 21 Feb 2026
- Last updated
- 6 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified individual participant data will be shared upon reasonable request for academic and research purposes, after publication of the main results. Requests will be reviewed by the principal investigator and data will be provided under a data use agreement.
Publications
Karacan I, Cakar HI, Sebik O, Yilmaz G, Cidem M, Kara S, Turker KS. A new method to determine reflex latency induced by high rate stimulation of the nervous system. Front Hum Neurosci. 2014 Jul 18;8:536. doi: 10.3389/fnhum.2014.00536. eCollection 2014.
PubMed 25100978
Study at a glance
From the registry record, last updated by the sponsor on 6 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation of Postural Stability and Load-Sensitive Neuromuscular Control Mechanisms in Vitamin D Deficiency
- ClinicalTrials.gov ID
- NCT07435935
- Acronym / sponsor ID
- BMR-VITD / OSTEOMALACIA-BMR-2026
- Conditions
- Vitamin D Deficiency
- Keywords
- Vitamin D Deficiency, Postural Stability, Balance Control, Neuromuscular Control, Surface Electromyography, Reflex Modulation, Bone Myoregulation Reflex, Standing Balance
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- Istanbul Physical Medicine Rehabilitation Training and Research HospitalOther government
- Study start
- 5 Mar 2026 (actual)
- Primary completion
- 25 Sep 2026 (actual)
- Study completion
- 25 Oct 2026 (estimated)
- First posted
- 27 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This observational study aims to investigate the relationship between vitamin D deficiency, postural stability, and neuromuscular control mechanisms in adults. The study will compare individuals with vitamin D deficiency and healthy controls.
Participants will undergo a single-session evaluation including surface electromyography and postural stability assessments during standing tasks under different loading and vibration conditions. No invasive procedures, medications, or blood sampling will be performed. Previously obtained routine laboratory results will be used for vitamin D status.
The study is designed to improve understanding of neuromuscular responses associated with vitamin D deficiency and to contribute to future rehabilitation strategies.
Detailed description
This single-center observational study is designed to evaluate postural stability and load-sensitive neuromuscular control mechanisms in adults with vitamin D deficiency.
Participants will be divided into two groups based on their vitamin D status: individuals with vitamin D deficiency and healthy controls. Vitamin D levels will be determined using previously obtained routine laboratory test results. No additional blood sampling will be performed for this study.
All participants will undergo a standardized assessment protocol in a single session. Surface electromyography will be used to record muscle activity during standing tasks under different postural and loading conditions. Measurements will be performed during single-leg and double-leg stance, with and without vibration stimulation. The procedures are non-invasive and do not involve any pharmacological intervention.
Postural stability parameters and neuromuscular response variables will be analyzed and compared between groups. The primary objective is to identify potential differences in reflex modulation and postural control associated with vitamin D deficiency.
The study aims to provide objective data on neuromuscular adaptations related to vitamin D status and to support future research in rehabilitation and balance training.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Vitamin D Deficiency Group | – | –Participants with laboratory-confirmed vitamin D deficiency based on routine clinical test results. All participants will undergo standardized non-invasive postural stability and surface electromyography assessments in a single session. |
| Healthy Control Group | – | –Participants with normal vitamin D status based on routine clinical test results and no history of balance or neuromuscular disorders. All participants will undergo standardized non-invasive postural stability and surface electromyography assessments in a single session. |
Who may qualify
- Ages
- 20 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Adults aged 20 to 40 years recruited from the outpatient clinics of Istanbul Physical Medicine and Rehabilitation Training and Research Hospital. Participants will include individuals with laboratory-confirmed vitamin D deficiency and healthy volunteers with normal vitamin D status.
Key inclusion criteria (5 listed)
- Age 20 to 40 years.
- Ability to provide written informed consent.
- Vitamin D deficiency group: serum 25-hydroxyvitamin D level <10 ng/mL measured within the last 3 months (routine clinical testing).
- Healthy control group: normal vitamin D status based on routine clinical testing within the last 3 months.
- No use of vitamin D or calcium supplementation within the last 3 months.
Key exclusion criteria (8 listed)
- Known metabolic bone disease other than vitamin D deficiency.
- Neurological disorder (central or peripheral) or neuromuscular disease.
- History of lower-limb surgery, fracture, or prosthesis affecting standing balance.
- Vestibular disorder.
- BMI >30 kg/m2.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Postural Stability Parameters
Time frame: Single assessment session (baseline)
Postural stability parameters measured during single-leg and double-leg standing using force platform and surface electromyography, including postural sway and neuromuscular response variables.
2 secondary outcomes
Neuromuscular Reflex and Muscle Activation Patterns
Time frame: Single assessment session (baseline)
Effect of Loading and Vibration on Postural Control
Time frame: Single assessment session (baseline)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Oct 2026.
- Results publication: PubMed 25100978Karacan I, Cakar HI, Sebik O, Yilmaz G, Cidem M, Kara S, Turker KS. A new method to determine reflex latency induced by high rate stimulation of the nervous system. Front Hum Neurosci. 2014 Jul 18;8:536. doi: 10.3389/fnhum.2014.00536. eCollection 2014.
- Individual participant dataSharing planned: Yes. De-identified individual participant data will be shared upon reasonable request for academic and research purposes, after publication of the main results. Requests will be reviewed by the principal investigator and data will be provided under a data use agreement.
Related trials for Vitamin D Deficiency
Not yet recruiting
Effect of Vitamin D Supplementation Added to Iron Therapy in Children With Iron Deficiency Anemia
Iron Deficiency Anemia
RecruitingObservational study
A Natural History Study of Bone and Mineral Disorders
Tumor Induced Osteomalcia, Osteomalacia
Enrolling by invitationObservational study
Strategies for Proactive Health in People With Kidney Function Decline
Renal Insufficiency,Chronic, Dietary Intake Patterns
Active, not recruiting
Preeclampsia Research on Vitamin D, Inflammation, & Depression
Pre-Eclampsia, Depression
Not yet recruiting
The Effectiveness of a Weight-dependent Algorithm for Dosing Vitamin D.
Hypovitaminosis D
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.
Selim Sezikli, MD principal investigator
Istanbul Physical Medicine and Rehabilitation 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?
An observational study of Vitamin D Deficiency, run by Istanbul Physical Medicine Rehabilitation Training and Research Hospital 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 8 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: looking for participants now, as of the sponsor's last update on 6 Oct 2026. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Selim Sezikli, MD (+905065101833, selimsezikli@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Postural Stability Parameters (time frame: Single assessment session (baseline)). 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 NCT07435935, which also lists 1 linked publication.
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 6 Oct 2026.