NCT07435935

Brief 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. 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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
24

participants targeted

Target at below P25 for all trials

Timeline
1mo left

Started Mar 2026

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress84%
Mar 2026Jul 2026

First Submitted

Initial submission to the registry

February 21, 2026

Completed
6 days until next milestone

First Posted

Study publicly available on registry

February 27, 2026

Completed
6 days until next milestone

Study Start

First participant enrolled

March 5, 2026

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 5, 2026

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

July 5, 2026

Expected
Last Updated

May 27, 2026

Status Verified

February 1, 2026

Enrollment Period

3 months

First QC Date

February 21, 2026

Last Update Submit

May 22, 2026

Conditions

Keywords

Vitamin D DeficiencyPostural StabilityBalance ControlNeuromuscular ControlSurface ElectromyographyReflex ModulationBone Myoregulation ReflexStanding BalanceRehabilitation ResearchPostural Sway

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (2)

  • Neuromuscular Reflex and Muscle Activation Patterns

    Single assessment session (baseline)

  • Effect of Loading and Vibration on Postural Control

    Single assessment session (baseline)

Study Arms (2)

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.

Eligibility Criteria

Age20 Years - 40 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodNon-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.

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Istanbul Physical Medicine and Rehabilitation Training and Research Hospital

Istanbul, 34186, Turkey (Türkiye)

RECRUITING

Related Publications (1)

  • 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.

MeSH Terms

Conditions

Vitamin D Deficiency

Condition Hierarchy (Ancestors)

AvitaminosisDeficiency DiseasesMalnutritionNutrition DisordersNutritional and Metabolic Diseases

Study Officials

  • Selim Sezikli, MD

    Istanbul Physical Medicine and Rehabilitation Training and Research Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Ilhan Karacan, Prof.

CONTACT

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Specialist in Physical Medicine and Rehabilitation

Study Record Dates

First Submitted

February 21, 2026

First Posted

February 27, 2026

Study Start

March 5, 2026

Primary Completion

June 5, 2026

Study Completion (Estimated)

July 5, 2026

Last Updated

May 27, 2026

Record last verified: 2026-02

Data Sharing

IPD Sharing
Will share

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.

Shared Documents
STUDY PROTOCOL, SAP, ICF
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.
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.

Locations