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

August 1, 2022 updated by: Mariam Samir Farg
Vitamin D level and its association with disease activity in Egyptian Rheumatoid arthritis (RA) patients

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Anticipated)

130

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

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

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
prevalence of vitamin D dificency in Rheumatoid arthritis
Time Frame: 3 years
prevalence of vitamin D dificency in Rheumatoid arthritis Egyption patients compared by healthy patients
3 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Mariam Samir Farg

Investigators

  • Study Director: Essam Ab Elmohsen, Assiut University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

September 1, 2022

Primary Completion (Anticipated)

February 28, 2023

Study Completion (Anticipated)

March 1, 2023

Study Registration Dates

First Submitted

March 10, 2022

First Submitted That Met QC Criteria

August 1, 2022

First Posted (Actual)

August 3, 2022

Study Record Updates

Last Update Posted (Actual)

August 3, 2022

Last Update Submitted That Met QC Criteria

August 1, 2022

Last Verified

August 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Vitamin d level

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Rheumatoid Arthritis (RA)

Clinical Trials on Vit D

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Congo

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe