Clinical trial NCT05997199: The Effect Vitamin D on the Recovery Rate of Bell Palsy
Official title: The Effect of Serum Vitamin D on the Recovery Rate of Bell Palsy
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Bell Palsy
Vitamin D Deficiency
Facial Paralysis
Lead sponsor: Umraniye Education and Research Hospital
Sponsor class: OTHER_GOV
First posted: 2023-08-18
Enrollment: 25
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients Diagnosed with Bell palsy and treated with standard medical treatment in the last 3 weeks

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Houseman Brahman (HB) Level
timeFrame: HB stages of the patients will be recorded at week 8.
measure: Facial Disability Index (FDI)
timeFrame: FDI of the patients will be recorded at week 8.
Secondary outcomes:
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Özlem Kaleoğlu
state: Üsküdar
Study officials:
affiliation: Umraniye Education and Research Hospital
name: Özlem Kaleoğlu, M.D
role: PRINCIPAL_INVESTIGATOR
References: