Vitamind: Vitamin d Level and it's Association With Disease Activity in Egyptian Rheumatoid Arthritis Patients

• Sponsor: Mariam Samir Farg (Other)
• Overall Status: Not yet recruiting
• CT.gov ID: NCT05486715
• Collaborator: (none)
• Enrollment: 130
• Anticipated Duration (Months): 5.9

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Rheumatoid Arthritis (RA)	Drug: Vit D

Detailed 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

Study Design

• Study Type: Observational
• Anticipated Enrollment: 130 participants
• Observational Model: Case-Control
• Time Perspective: Prospective
• Official Title: Vitamin d Level and it's Association With Disease Activity in Egyptian Rheumatoid Arthritis Patients
• Anticipated Study Start Date: Sep 1, 2022
• Anticipated Primary Completion Date: Feb 28, 2023
• Anticipated Study Completion Date: Mar 1, 2023

Arms and Interventions

Arm	Intervention/Treatment
65 rheumatoid arthritis patient Vitamin d effect on rheumatoid arthritis activity on 65 rheumatoid arthritis patients and 65 healthy population	Drug: Vit D; Vit D; Other Names: Placebo
65 healthy population Vitamin d effect on rheumatoid arthritis activity on 65 rheumatoid arthritis patients and 65 healthy population	Drug: Vit D; Vit D; Other Names: Placebo

Outcome Measures

Primary Outcome Measures

1. prevalence of vitamin D dificency in Rheumatoid arthritis [3 years]

   prevalence of vitamin D dificency in Rheumatoid arthritis Egyption patients compared by healthy patients

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 75 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• Mariam Samir Farg

Investigators

• Study Director: Essam Ab Elmohsen, Assiut University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Mariam Samir Farg, Mariam farag, Assiut University
• ClinicalTrials.gov Identifier: NCT05486715
• Other Study ID Numbers: Vitamin d level
• First Posted: Aug 3, 2022
• Last Update Posted: Aug 3, 2022
• Last Verified: Aug 1, 2022

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Arthritis; Arthritis, Rheumatoid

Study Results

No Results Posted as of Aug 3, 2022