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CompletedNCT05997199Updated Apr 2, 2025

The Effect Vitamin D on the Recovery Rate of Bell Palsy

An observational study in Bell Palsy, Vitamin D Deficiency and Facial Paralysis, sponsored by Umraniye Education and Research Hospital. Completed at 1 site in Turkey. Open to participants aged 18 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-04-02.

Sponsored by Umraniye Education and Research Hospital · Observational

Study type
Observational
Model
Case-control
Time perspective
Prospective
Enrollment
25
Ages
18 Years to 65 Years
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Bell Palsy
  • Vitamin D Deficiency
  • Facial Paralysis
03

In context

Bell Palsy

85 studies on the registry are indexed under Bell Palsy; 30 are open to participants now.

This study's enrollment of 25 is below the median of 80 across 13 observational studies indexed under Bell Palsy.

Browse Bell Palsy studies →

Lead sponsor

Umraniye Education and Research Hospital is the lead sponsor of 61 studies on the registry; 12 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
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

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Being cooperative-orientated
  • Willing to participate in the Physical Therapy home exercise program

Exclusion criteria

Exclusion Criteria:

  • Being Non cooperative, disorientated
  • Failure to comply with the Physical Therapy home exercise program
  • History of
  • Additional neurological disease
  • Having cranial pathologies
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Cancer (malignancy)

Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.

Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.

05

Study design

Observational model
Case-control
Time perspective
Prospective
Enrollment
25 participants (actual)
Patient registry
No

Groups and cohorts

  • Group 1

    Patients with vitamin D deficiency and having Vitamin D Replacement

    Dietary Supplement: Vitamin D replacement

  • Group 2

    Control Group. Patients with vitamin D deficiency but not getting Vitamin D replacement

Interventions

  • Dietary supplementVitamin D replacement

    Group 1 with vitamin D deficiency will be getting a standart vitamin D replacement of 50.000 IU/week for 8 weeks.

06

What researchers measure

Primary outcomes

  1. 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.

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

  2. 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.

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

07

Study locations

1 site
  • Özlem Kaleoğlu
    Istanbul, Üsküdar 34000, Turkey
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 2, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05997199
Lead sponsor
Umraniye Education and Research Hospital
Responsible party
Özlem Kaleoğlu, MD (Principle Investigator, Umraniye Education and Research Hospital) — Principal investigator
First posted
Aug 18, 2023
Start date
Jun 1, 2022
Primary completion
Sep 1, 2024
Completion
Sep 15, 2024
Last update
Apr 2, 2025

Study contacts

Özlem Kaleoğlu, M.D
principal investigator · Umraniye Education and Research Hospital

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Mar 2025. You cannot join it, but the record below documents what was studied.

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