The Effect Vitamin D on the Recovery Rate of Bell Palsy

NCT05997199 | Completed

• 1 other identifier: B.10.1.THK.4.34.H.GP.0.01/76
• Study Type: observational
• Target: 25
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Bell Palsy; Vitamin D Deficiency; Facial Paralysis

Outcome Measures

Primary Outcomes (2)

• Houseman Brahman (HB) Level

  Facial palsy stages of patients will be graded from 1 to 6 according to the Houseman Brahman (HB) staging system. Grade 1 refers to normal facial nerve function whereas 6 refer to complete paralysis.

  HB stages of the patients will be recorded at week 8.

• Facial Disability Index (FDI)

  This scale consists of 10 questions and is a validated test evaluating the physical and social function of the patient. It is scored out of 100. Higher score is the best result.

  FDI of the patients will be recorded at week 8.

Study Arms (2)

Group 1

Patients with vitamin D deficiency and having Vitamin D Replacement

Dietary Supplement: Vitamin D replacement

Group 2

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

Interventions

Vitamin D replacement 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 1

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients Diagnosed with Bell palsy and treated with standard medical treatment in the last 3 weeks

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Umraniye Education and Research Hospital: lead

Study Sites (1)

Özlem Kaleoğlu

Istanbul, Üsküdar, 34000, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Bell Palsy; Vitamin D Deficiency; Facial Paralysis

Condition Hierarchy (Ancestors)

Herpesviridae Infections; DNA Virus Infections; Virus Diseases; Infections; Mouth Diseases; Stomatognathic Diseases; Facial Nerve Diseases; Cranial Nerve Diseases; Nervous System Diseases; Avitaminosis; Deficiency Diseases; Malnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Paralysis; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Özlem Kaleoğlu, M.D

  Umraniye Education and Research Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principle Investigator

Study Record Dates

• First Submitted: August 10, 2023
• First Posted: August 18, 2023
• Study Start: June 1, 2022
• Primary Completion: September 1, 2024
• Study Completion: September 15, 2024
• Last Updated: April 2, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)