Clinical Trials Logo

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
Secondary ID
Status Active, not recruiting
Phase
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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.
See also
  Status Clinical Trial Phase
Active, not recruiting NCT04244474 - Effect of Vitamin D Supplementation on Improvement of Pneumonic Children Phase 1/Phase 2
Recruiting NCT05459298 - ViDES Trial (Vitamin D Extra Supplementation) N/A
Suspended NCT03652987 - Endocrine and Menstrual Disturbances in Women With Polycystic Ovary Syndrome (PCOS)
Completed NCT04476511 - The Efficacy and the Safety of Vitamin D3 30,000 IU for Loading Dose Schedules Phase 3
Completed NCT03920150 - Vitamin D 24'000 IU for Oral Intermittent Supplementation Phase 3
Completed NCT03264625 - The Effects of Oral Vitamin D Supplementation on the Prevention of Peritoneal Dialysis-related Peritonitis Phase 2
Completed NCT04183257 - Effect of Escalating Oral Vitamin D Replacement on HOMA-IR in Vitamin D Deficient Type 2 Diabetics Phase 4
Recruiting NCT05084248 - Vitamin D Deficiency in Adults Following a Major Burn Injury Phase 4
Completed NCT05506696 - Vitamin D Supplementation Study N/A
Completed NCT00092066 - A Study to Evaluate the Safety, Tolerability, and Efficacy of an Investigational Drug and Dietary Supplement in Men and Postmenopausal Women With Osteoporosis (0217A-227) Phase 3
Completed NCT03234218 - Vitamin D Levels in Liver Transplantation Recipients Prospective Observational Study
Completed NCT03203382 - Corneal Nerve Structure in Sjogren's
Completed NCT02714361 - A Study to Investigate the Effect of Vitamin D3 Supplementation on Iron Status in Iron Deficient Women N/A
Completed NCT02906319 - Vitamin D and HbA1c Levels in Diabetic Patients With CKD N/A
Completed NCT02118129 - Vitamin D Among Young Adults: an Intervention Study Using a Mobile 'App'. N/A
Not yet recruiting NCT01419821 - Vitamin D and Its Affect on Growth Rates and Bone Mineral Density Until Age 5 N/A
Completed NCT02275650 - The Role of Narrowband Ultraviolet B Exposure in the Maintenance of Vitamin D Levels During Winter N/A
Completed NCT02187146 - The Effects of Serum Vitamin D and IVF Outcome N/A
Completed NCT01651000 - Safety and Efficacy of CTAP101 to Treat Secondary Hyperparathyroidism in Stage 3 or 4 CKD and Vitamin D Insufficiency Phase 3
Completed NCT01741181 - Vitamin D Supplementation in Patients With Diabetes Mellitus Type 2 Phase 4