Vitamin D Deficiency Clinical Trial
Official title:
The Effect of Serum Vitamin D on the Recovery Rate of Bell Palsy
Verified date | September 2023 |
Source | Umraniye Education and Research Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
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 |
Country | Name | City | State |
---|---|---|---|
Turkey | Özlem Kaleoglu | Istanbul | Üsküdar |
Lead Sponsor | Collaborator |
---|---|
Umraniye Education and Research Hospital |
Turkey,
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. |
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