The Effect Vitamin D on the Recovery Rate of Bell Palsy

The Effect of Serum Vitamin D on the Recovery Rate of Bell Palsy

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.

Study Overview

• Status: Completed
• Conditions: Vitamin D Deficiency; Bell Palsy; Facial Paralysis
• Intervention / Treatment: Dietary supplement: Vitamin D replacement

Detailed Description

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.

• Study Type: Observational
• Enrollment (Actual): 25

Contacts and Locations

Study Locations

• Turkey
  • Üsküdar
    • Istanbul, Üsküdar, Turkey, 34000
      • Özlem Kaleoğlu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

• Sampling Method: Probability Sample

Study Population

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

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Group 1; Patients with vitamin D deficiency and having Vitamin D Replacement	Dietary supplement: 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.
Group 2; Control Group. Patients with vitamin D deficiency but not getting Vitamin D replacement

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.

Collaborators and Investigators

• Sponsor: Umraniye Education and Research Hospital
• Investigators: Principal Investigator: Özlem Kaleoğlu, M.D, Umraniye Education and Research Hospital

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2022
• Primary Completion (Actual): September 1, 2024
• Study Completion (Actual): September 15, 2024

Study Registration Dates

• First Submitted: August 10, 2023
• First Submitted That Met QC Criteria: August 10, 2023
• First Posted (Actual): August 18, 2023

Study Record Updates

• Last Update Posted (Actual): April 2, 2025
• Last Update Submitted That Met QC Criteria: March 27, 2025
• Last Verified: March 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neurologic Manifestations; Mouth Diseases; Stomatognathic Diseases; Nervous System Diseases; Nutrition Disorders; Infections; Virus Diseases; DNA Virus Infections; Herpesviridae Infections; Cranial Nerve Diseases; Avitaminosis; Deficiency Diseases; Malnutrition; Facial Nerve Diseases; Vitamin D Deficiency; Paralysis; Bell Palsy; Facial Paralysis; Physiological Effects of Drugs; Bone Density Conservation Agents; Micronutrients; Vitamins; Vitamin D
• Other Study ID Numbers: B.10.1.THK.4.34.H.GP.0.01/76

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No