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Recruiting NCT07435935

Bone Myoregulation Reflex and Postural Control in Vitamin D Deficiency

Observational Vitamin D Deficiency

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
This is an observational study: the protocol does not assign a study treatment.
Who it may be relevant to
Registry conditions: Vitamin D Deficiency. Basic parameters: 20 years — 40 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Turkey (Türkiye)
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

Investigation of Postural Stability and Load-Sensitive Neuromuscular Control Mechanisms in Vitamin D Deficiency

Overview

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.

Primary outcome measures

  • Postural Stability Parameters [Time frame: Single assessment session (baseline)]
Secondary outcome measures (2)
  • 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)]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Observational model
Case-control

Study locations

Turkey (Türkiye) · 1 center
  • Istanbul Physical Medicine and Rehabilitation Training and Research Hospital — Istanbul

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. PMID 25100978

Identifiers

NCT: NCT07435935 · OSTEOMALACIA-BMR-2026

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗