The Effect Vitamin D on the Recovery Rate of Bell Palsy

NCT ID: NCT05997199

Last Updated: 2025-04-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

25 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-06-01

Study Completion Date

2024-09-15

Brief Summary

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Patients aged between 18-65 who visit the Physical Medicine and Rehabilitation outpatient clinic diagnosed with Bell Palsy will be included in the study. The patients' Bell Palsy grade will be evaluated by Houseman Brahman (HB) Scale and their disability level will be evaluated by Facial Disability Index (FDI). Their serum vitamin D level will be noted. The patients having vitamin D deficiency will be randomized into two groups. Group 1 will be given 50.000 IU/week vitamin D replacement for 8 weeks. All the patients will be included in a standard physical therapy and home exercise program. Both groups will be asked for a control visit at weeks 8.Their clinical recovery will be evaluated by HB staging and FDI by the Physical Medicine and Rehabilitation specialist who is blind to the randomization.

Detailed Description

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Patients aged between 18-65 who visit the Physical Medicine and Rehabilitation outpatient clinic diagnosed with Bell Palsy will be included in the study. Facial palsy stages of patients will be graded from 1 to 6 according to the Houseman Brahman (HB) staging system. In order to determine the disability criteria of the patients, a form called Facial Disability Index (FDI)-Facial Disability Index will be filled. This scale consists of 10 questions and is a validated test evaluating the physical and social function of the patient. The patients having vitamin D deficiency will be randomized into two groups. One group will be getting a vitamin d replacement treatment for 8 weeks. A physical therapy program in the form of a standard exercise program including electrical stimulation and facial paralysis exercises will be organized for all the patients. The patients will be evaluated at 8th week by HB and FDI.

Conditions

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Bell Palsy Vitamin D Deficiency Facial Paralysis

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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Group 1

Patients with vitamin D deficiency and having Vitamin D Replacement

Vitamin D replacement

Intervention Type DIETARY_SUPPLEMENT

Group 1 with vitamin D deficiency will be getting a standart vitamin D replacement of 50.000 IU/week for 8 weeks.

Group 2

Control Group. Patients with vitamin D deficiency but not getting Vitamin D replacement

No interventions assigned to this group

Interventions

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Vitamin D replacement

Group 1 with vitamin D deficiency will be getting a standart vitamin D replacement of 50.000 IU/week for 8 weeks.

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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Inclusion Criteria

* Being cooperative-orientated
* Willing to participate in the Physical Therapy home exercise program

Exclusion Criteria

* Being Non cooperative, disorientated
* Failure to comply with the Physical Therapy home exercise program
* History of malignancy
* Additional neurological disease
* Having cranial pathologies
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Umraniye Education and Research Hospital

OTHER_GOV

Sponsor Role lead

Responsible Party

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Özlem Kaleoğlu, MD

Principle Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Özlem Kaleoğlu, M.D

Role: PRINCIPAL_INVESTIGATOR

Umraniye Education and Research Hospital

Locations

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Özlem Kaleoğlu

Istanbul, Üsküdar, Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

Other Identifiers

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B.10.1.THK.4.34.H.GP.0.01/76

Identifier Type: -

Identifier Source: org_study_id

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