The Effect Vitamin D on the Recovery Rate of Bell Palsy

Vitamin D Deficiency Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05997199
• Other study ID #: B.10.1.THK.4.34.H.GP.0.01/76
• Status: Active, not recruiting
• Start date: June 1, 2023
• Est. completion date: September 15, 2023

Study information

• Verified date: September 2023
• Source: Umraniye Education and Research Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 25
• Est. completion date: September 15, 2023
• Est. primary completion date: September 1, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Bell Palsy
• Facial Paralysis
• Paralysis
• Vitamin D Deficiency

Intervention

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.

Locations

Country	Name	City	State
Turkey	Özlem Kaleoglu	Istanbul	Üsküdar

Sponsors (1)

Lead Sponsor	Collaborator
Umraniye Education and Research Hospital

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.
Primary	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.