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

NCT05486715 | Unknown

• 1 other identifier: Vitamin d level
• Study Type: observational
• Target: 130
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

Conditions

Rheumatoid Arthritis (RA)

Outcome Measures

Primary Outcomes (1)

• prevalence of vitamin D dificency in Rheumatoid arthritis

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

  3 years

Study Arms (2)

65 rheumatoid arthritis patient

Vitamin d effect on rheumatoid arthritis activity on 65 rheumatoid arthritis patients and 65 healthy population

Drug: Vit D

65 healthy population

Vitamin d effect on rheumatoid arthritis activity on 65 rheumatoid arthritis patients and 65 healthy population

Drug: Vit D

Interventions

Vit D DRUG

Vit D

Also known as: Placebo

65 healthy population; 65 rheumatoid arthritis patient

Eligibility Criteria

• Age: 18 Years - 75 Years
• Gender Eligibility Details: Egyptions
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Sample size was calculated using Epi- Info7. Based on previous study the prevalence of vitamin D insufficiency and deficiency in RA patients was 56% (Cesshetti 2016. ). With a confidence limits of 8% and a confidence level of 80% the minimum number of patients required for this study is 65 patients RA and 65 of healthy

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Mariam Samir Farg: lead

MeSH Terms

Conditions

Arthritis, Rheumatoid

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases

Study Officials

• Essam Ab Elmohsen

  Assiut University

  STUDY DIRECTOR

Central Study Contacts

Mariam Sa Farag, Master

CONTACT

‪0155 553 2738‬; ‬mariam.samir20495@gmail.com

Perer At Munir, Master

CONTACT

01553529181; Peteratef662@gmail.com

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Mariam farag

Study Record Dates

• First Submitted: March 10, 2022
• First Posted: August 3, 2022
• Study Start: September 1, 2022
• Primary Completion: February 28, 2023
• Study Completion: March 1, 2023
• Last Updated: August 3, 2022

Record last verified: 2022-08

Data Sharing

• IPD Sharing: Will not share