Rheumatoid Arthritis (RA)VitamindNCT05486715
Vitamin d Level and it's Association With Disease Activity in Egyptian Rheumatoid Arthritis Patients
An observational study of Rheumatoid Arthritis (RA), run by Mariam Samir Farg.
Trial summary
Vitamin D level and its association with disease activity in Egyptian Rheumatoid arthritis (RA) patients Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Rheumatoid Arthritis (RA)
- What is being tested?
- Vit D
- How many people
- 130 participants
- Where
- No sites listed yet
- Study dates
- 1 Sep 2022to 1 Mar 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
No sites are listed yet.
About this study
Vitamin D level and its association with disease activity in Egyptian Rheumatoid arthritis (RA) patients
Read the 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
- Conditions
- Rheumatoid Arthritis (RA)
- Being tested
- Vit D
- Medical subject headings
- Arthritis, Rheumatoid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vit DDrug
Also called Placebo
Vit D
| Study group | Role | What they receive |
|---|---|---|
| 65 rheumatoid arthritis patient | Vitamin d effect on rheumatoid arthritis activity on 65 rheumatoid arthritis patients and 65 healthy population Receives: Drug: Vit D | |
| 65 healthy population | Vitamin d effect on rheumatoid arthritis activity on 65 rheumatoid arthritis patients and 65 healthy population Receives: Drug: Vit D |
What is being measured
The primary outcome is the main question the study is designed to answer.
prevalence of vitamin D dificency in Rheumatoid arthritis
prevalence of vitamin D dificency in Rheumatoid arthritis Egyption patients compared by healthy patients
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Aug 2022
- Study start1 Sep 2022 (estimated)
- Primary completion28 Feb 2023 (estimated)
- Study completion1 Mar 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rheumatoid Arthritis (RA)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 130 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mariam Samir Farg
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Mariam Samir Farg, Assiut University
- Investigators
- Essam Ab Elmohsen, Study director, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05486715
- Sponsor's protocol ID
- Vitamin d level
- Acronym
- Vitamind
- Status last verified
- Aug 2022
- First submitted
- 10 Mar 2022
- Last updated
- 3 Aug 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Vitamin d Level and it's Association With Disease Activity in Egyptian Rheumatoid Arthritis Patients
- ClinicalTrials.gov ID
- NCT05486715
- Acronym / sponsor ID
- Vitamind / Vitamin d level
- Conditions
- Rheumatoid Arthritis (RA)
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 130 participants (estimated)
- Lead sponsor
- Mariam Samir FargUniversity, hospital or other
- Study start
- 1 Sep 2022 (estimated)
- Primary completion
- 28 Feb 2023 (estimated)
- Study completion
- 1 Mar 2023 (estimated)
- First posted
- 3 Aug 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Vitamin D level and its association with disease activity in Egyptian Rheumatoid arthritis (RA) patients
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
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 65 rheumatoid arthritis patient | – | Drug: Vit DVitamin d effect on rheumatoid arthritis activity on 65 rheumatoid arthritis patients and 65 healthy population |
| 65 healthy population | – | Drug: Vit DVitamin d effect on rheumatoid arthritis activity on 65 rheumatoid arthritis patients and 65 healthy population |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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
Key inclusion criteria (1 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Vit DAlso: PlaceboVit D | Drug | 65 healthy population, 65 rheumatoid arthritis patient |
Primary outcome
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Aug 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Essam Ab Elmohsen study director
Assiut University
Questions about this trial
What is this clinical trial studying?
An observational study of Rheumatoid Arthritis (RA), run by Mariam Samir Farg.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 3 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Mariam Sa Farag, Master (0155 553 2738, mariam.samir20495@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
prevalence of vitamin D dificency in Rheumatoid arthritis (time frame: 3 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Aug 2022.