The Effect 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.

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Key information

Conditions

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

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Özlem Kaleoğlu

Istanbul, Üsküdar, 34000, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

Houseman Brahman (HB) Level

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

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.
Facial Disability Index (FDI)

Time frame: FDI of the patients will be recorded at week 8.

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.

Sponsors and collaborators

Lead sponsor

Umraniye Education and Research Hospital

Other Gov

Registry information

Official study title

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

Important dates

Study start: 2022
Primary completion: 2024
Study completion: 2024
First posted: Aug 18, 2023
Registry last updated: Apr 2, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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