Bone Myoregulation Reflex and Postural Control in Vitamin D Deficiency (BMR-VITD)

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.

Study Overview

• Status: Recruiting
• Conditions: Vitamin D Deficiency

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 Type: Observational
• Enrollment (Estimated): 24

Contacts and Locations

• Study Contact: Name: Selim Sezikli, MD; Phone Number: +905065101833; Email: selimsezikli@hotmail.com
• Study Contact Backup: Name: Ilhan Karacan, Prof.; Phone Number: +905327005361; Email: mdkaracanilhan@gmail.com

Study Locations

• Turkey (Türkiye)
  • Istanbul, Turkey (Türkiye), 34186
    • Recruiting
    • Istanbul Physical Medicine and Rehabilitation Training and Research Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-Probability Sample

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.

Description

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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.

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
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 the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Single assessment session (baseline)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Neuromuscular Reflex and Muscle Activation Patterns	Surface electromyography-derived muscle activation and reflex modulation parameters recorded under different loading and vibration conditions.	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.	Single assessment session (baseline)

Collaborators and Investigators

• Sponsor: Istanbul Physical Medicine Rehabilitation Training and Research Hospital
• Investigators: Principal Investigator: Selim Sezikli, MD, Istanbul Physical Medicine and Rehabilitation Training and Research Hospital

Publications and helpful links

General 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.

Study record dates

Study Major Dates

• Study Start (Actual): March 5, 2026
• Primary Completion (Estimated): June 5, 2026
• Study Completion (Estimated): July 5, 2026

Study Registration Dates

• First Submitted: February 21, 2026
• First Submitted That Met QC Criteria: February 21, 2026
• First Posted (Actual): February 27, 2026

Study Record Updates

• Last Update Posted (Actual): May 27, 2026
• Last Update Submitted That Met QC Criteria: May 22, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Keywords: Postural Stability; Standing Balance; Vitamin D Deficiency; Surface Electromyography; Balance Control; Rehabilitation Research; Postural Sway; Neuromuscular Control; Bone Myoregulation Reflex; Reflex Modulation
• Additional Relevant MeSH Terms: Nutrition Disorders; Avitaminosis; Deficiency Diseases; Malnutrition; Nutritional and Metabolic Diseases; Vitamin D Deficiency
• Other Study ID Numbers: OSTEOMALACIA-BMR-2026

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: 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.
• IPD Sharing Time Frame: Supporting documents and de-identified individual participant data will be made available upon reasonable request after publication of the main results. Requests will be reviewed by the principal investigator and shared for academic purposes under a data use agreement.
• IPD Sharing Access Criteria: Access to de-identified individual participant data and supporting documents (study protocol, statistical analysis plan, and informed consent form) will be granted to qualified researchers upon reasonable request for academic and non-commercial purposes. Requests will be reviewed by the principal investigator. Data will be shared through secure electronic transfer under a data use agreement.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No