NCT06282640

Brief Summary

Therefore, we aimed to evaluate the effectiveness of vitamin D replacement therapy on pain, electrophysiological parameters, ultrasonographic measurement results and functional status scales in CTS patients with low serum vitamin D levels.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
87

participants targeted

Target at P50-P75 for phase_4

Timeline
Completed

Started Dec 2021

Shorter than P25 for phase_4

Geographic Reach
1 country

1 active site

Status
completed

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 Start

First participant enrolled

December 30, 2021

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2022

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 30, 2022

Completed
1.4 years until next milestone

First Submitted

Initial submission to the registry

January 29, 2024

Completed
1 month until next milestone

First Posted

Study publicly available on registry

February 28, 2024

Completed
Last Updated

February 28, 2024

Status Verified

February 1, 2024

Enrollment Period

6 months

First QC Date

January 29, 2024

Last Update Submit

February 20, 2024

Conditions

Keywords

Carpal Tunnel SyndromeVitamin D DeficiencyElectrophysiologia

Outcome Measures

Primary Outcomes (1)

  • electrophysiological scale.

    Electrophysiological Evaluation: Neurowerk (SIGMA-Medizin-TechnicGmbH/Germany) brand ENMG device was used. Patients were evaluated at room temperature of approximately 25 °C. All measurements were made by the same doctor. Our clinic's reference values for the diagnosis of CTS are shown below

    at the baseline and immediately after treatment

Secondary Outcomes (1)

  • monofilament test

    at the baseline and immediately after treatment

Other Outcomes (1)

  • Boston symptom severity scale

    at the baseline and immediately after treatment

Study Arms (1)

Vitamin D in Carpal Tunnel Syndrome

EXPERIMENTAL
Drug: Vitamin D

Interventions

Vitamin D replacement therapy was administered at 50,000 IU weekly for 8 weeks.

Vitamin D in Carpal Tunnel Syndrome

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • years old male or female gender
  • Those with mild to moderate CTS according to ENMG,
  • Vitamin D level \<20.

You may not qualify if:

  • Severe CTS according to ENMG
  • Thenar region atrophy
  • diabetes mellitus,
  • rheumatoid arthritis,
  • hyperthyroidism,
  • hypothyroidism
  • Traumatic nerve injury, history of surgery
  • Polyneuropathy
  • Pregnancy
  • Severe psychiatric illness
  • Poor orientation and cooperation,
  • Injection (corticosteroid, ozone, stem cell…) applied for CTS treatment within 3 months

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kayseri City Hospital

Kayseri, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Carpal Tunnel SyndromeVitamin D Deficiency

Interventions

Vitamin D

Condition Hierarchy (Ancestors)

Median NeuropathyMononeuropathiesPeripheral Nervous System DiseasesNeuromuscular DiseasesNervous System DiseasesNerve Compression SyndromesCumulative Trauma DisordersSprains and StrainsWounds and InjuriesAvitaminosisDeficiency DiseasesMalnutritionNutrition DisordersNutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

SecosteroidsSteroidsFused-Ring CompoundsPolycyclic Compounds

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NA
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR INVESTIGATOR
PI Title
medical doctor

Study Record Dates

First Submitted

January 29, 2024

First Posted

February 28, 2024

Study Start

December 30, 2021

Primary Completion

June 30, 2022

Study Completion

August 30, 2022

Last Updated

February 28, 2024

Record last verified: 2024-02

Locations