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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT05486715
Other study ID # Vitamin d level
Secondary ID
Status Not yet recruiting
Phase
First received
Last updated
Start date September 1, 2022
Est. completion date March 1, 2023

Study information

Verified date August 2022
Source Assiut University
Contact Mariam Sa Farag, Master
Phone ?0155 553 2738?
Email ?mariam.samir20495@gmail.com
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

Vitamin D level and its association with disease activity in Egyptian Rheumatoid arthritis (RA) patients


Description:

Rheumatoid arthritis (RA) is a chronic inflammatory disease that affects about 1% of the human population. Its incidence increases between 25 and 55 years and is the most common type of chronic inflammatory arthritis . It affects joints bilaterally with synovial hyperplasia, cartilage erosion, bone destruction, and progressive loss of function . also characterized by systemic features and joint involvement. It can lead to significant morbidity and mortality so early diagnosis and proper treatment are crucial in decreasing the burden of this disease . According to the World Health Organization mortality database of 31 countries, RA accounts for almost 18% of all deaths caused by different types of arthritis and other musculoskeletal diseases, but the exact cause of RA remains unknown


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 130
Est. completion date March 1, 2023
Est. primary completion date February 28, 2023
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 75 Years
Eligibility Inclusion Criteria: - Both males and females in the age group of 1875 years having RA according to the American College of Rheumatology European League Against Rheumatism 2010 criteria (Meena et al., 2018). Will enrolled in this study Exclusion Criteria: - Patients with malnutrition, hepatic and renal dysfunction, hyperparathyroidism, hyperthyroidism, diabetes mellitus, and patients on Vitamin D supplementation in the past 6 months or on medications that can affect bone and Vitamin D metabolism (anticonvulsants, diuretics, and thyroxin) were excluded from this study. - Patients with overlap syndrome - known allergy to DMARDs, 1,25 dihydroxy vitamin D3 or calcium supplements

Study Design


Intervention

Drug:
Vit D
Vit D

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Mariam Samir Farg

Outcome

Type Measure Description Time frame Safety issue
Primary prevalence of vitamin D dificency in Rheumatoid arthritis prevalence of vitamin D dificency in Rheumatoid arthritis Egyption patients compared by healthy patients 3 years
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