Study of Some Risk Factors for Developing RA

NCT ID: NCT03624179

Last Updated: 2018-08-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

60 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-08-15

Study Completion Date

2018-09-20

Brief Summary

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Introduction Rheumatoid arthritis (RA), a chronic autoimmune disease of unknown etiology, .If not managed early , RA can result in irreversible, painful, and disabling joint damage. RA is often diagnosed using predefined criteria that necessitate clinical, laboratory, and radiologic examinations.

The prevalence of RA among adults is approximately 1-2% affecting women two to four times more often than men.Although RA risk increases with age, it can manifest at any stage of life, including childhood, adolescence, and adulthood.(1-4)( Karlson EW, Mandl LA, Hankinson SE, Grodstein F, Karlson EW, Mandl LA, Hankinson SE, Grodstein F., Karlson EW, Mandl LA, Hankinson SE, Grodstein F, Karlson EW, Mandl LA, Hankinson SE, Grodstein F) To date, a limited number of RA risk or protective factors have been identified, with genetic predisposition to autoimmune response (eg, HLA-DR4 gene) and repeated environmental exposures (eg, tobacco smoke) playing a major role.(3)(Karlson EW, Mandl LA, Hankinson SE, Grodstein F) Heritability of RA is well-established because the lifetime risk of RA and related autoimmune diseases (namely, systemic lupus erythematosus, ankylosing spondylitis, scleroderma, Sjo¨gren's syndrome, and hypothyroidism) increases 1.5 to 3 times in children of women diagnosed with RA.

Detailed Description

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Patients will answer the following the questationnaire:

Name age gender

1 Socio echonomic status (average salary \\year) (Education) (Job) (residence)

1. Body mass index (height\\wt2)
2. Disease duration in months.
3. Smoking (yes) (No) Passive smoker Ex smoker
4. Reproductive history:

* age of menarche….
* menstrual cycle….. regular or not……. P / C
* How many pregnancies…….. living.

* Abortion.
* patient age at first birth (….).
* breast feeding…..(yes)…….(no)
* use of contraceptives (yes)…pills injections IUD (N0)……
* Does patient get pregnant during disease?...(Yes)……(no)….. Does the arthritis improved (…)or got worse (…..) -flared during the purpurium.(yes) … (No)
* age of menupause…. 10 Exposure to sun….(yes)…..(No) 11 -Theraputic history… (Newly diagnosed)

* (Previously diagnosed),
* Does the patient receiving ttt? (yes) (Steroid)……. (NSAIDS)……. (2nd line drugs) (.Methotrexat(.…), Leflonamide (….) Hydroquine(….) (NO)……..
* The study will include 100 patients fullfilling ACR 2010
* Patients well subjected to

* Through clinical examination with emphysis on joints examination
* venous blood sampling will withdrawn and the following investigations will be done.
* Serum VIT D level
* Serum calcium and phosphorus
* Anti cyclic citrullinated peptide.
* ESR

Conditions

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Rheumatoid Arthritis

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Rheumatoid arthritis patients

complete blood count, Erythrocyte sedimentation rate, C reactive protien ,rheumatoid factor,Anti cyclic citrullinated peptide antibody

No interventions assigned to this group

healthy control

complete blood count, Erythrocyte sedimentation rate, C reactive protien ,rheumatoid factor,Anti cyclic citrullinated peptide antibody

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

* patients with rheumatoid arthritis diagnosed based on american collegue of rheumatology 2010 criteria with no history of vit D therapy

Exclusion Criteria

* patients with rheumatoid arthritis on vit D supplements
* patient refusal
* patient not fullfill american collegue of rheumatology 2010 citeria for diagnosis pf rheumatoid arthritis
Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Assiut University

OTHER

Sponsor Role lead

Responsible Party

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Ebtesam mostafa

principle investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Central Contacts

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Ebtsam M Abd El Hakeem, MIS

Role: CONTACT

01065889869

EL Badry I Abo Elnour, MD

Role: CONTACT

01091131611

References

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Almodovar PI. Dermatology diagnosis. Tuberculoid leprosy. Bol Asoc Med P R. 1986 Dec;78(12):514-5. No abstract available.

Reference Type BACKGROUND
PMID: 3468952 (View on PubMed)

Jankosky C, Deussing E, Gibson RL, Haverkos HW. Viruses and vitamin D in the etiology of type 1 diabetes mellitus and multiple sclerosis. Virus Res. 2012 Feb;163(2):424-30. doi: 10.1016/j.virusres.2011.11.010. Epub 2011 Nov 20.

Reference Type BACKGROUND
PMID: 22119899 (View on PubMed)

Ginns LC, Ryu JH, Rogol PR, Sprince NL, Oliver LC, Larsson CJ. Natural killer cell activity in cigarette smokers and asbestos workers. Am Rev Respir Dis. 1985 Jun;131(6):831-4. doi: 10.1164/arrd.1985.131.6.831.

Reference Type BACKGROUND
PMID: 4003932 (View on PubMed)

Hodges GR, Loker EF Jr. Letter: Fatal pneumonia cause: avirulent wild-type ADV-7 or vaccine strain ADV-7. Chest. 1975 Jun;67(6):740. No abstract available.

Reference Type BACKGROUND
PMID: 165046 (View on PubMed)

Mendes EN, Queiroz DM, Rocha GA, Nogueira AM, Carvalho AC, Lage AP, Barbosa AJ. Histopathological study of porcine gastric mucosa with and without a spiral bacterium ("Gastrospirillum suis"). J Med Microbiol. 1991 Dec;35(6):345-8. doi: 10.1099/00222615-35-6-345.

Reference Type BACKGROUND
PMID: 1753392 (View on PubMed)

Karlson EW, Mandl LA, Hankinson SE, Grodstein F. Do breast-feeding and other reproductive factors influence future risk of rheumatoid arthritis? Results from the Nurses' Health Study. Arthritis Rheum. 2004 Nov;50(11):3458-67. doi: 10.1002/art.20621.

Reference Type RESULT
PMID: 15529351 (View on PubMed)

Kawakami M, Watanabe N, Ogawa H, Kato A, Sando H, Yamada N, Murase T, Takaku F, Shibata S, Oda T. Cachectin/TNF kills or inhibits the differentiation of 3T3-L1 cells according to developmental stage. J Cell Physiol. 1989 Jan;138(1):1-7. doi: 10.1002/jcp.1041380102.

Reference Type RESULT
PMID: 2783422 (View on PubMed)

Merlino LA, Cerhan JR, Criswell LA, Mikuls TR, Saag KG. Estrogen and other female reproductive risk factors are not strongly associated with the development of rheumatoid arthritis in elderly women. Semin Arthritis Rheum. 2003 Oct;33(2):72-82. doi: 10.1016/s0049-0172(03)00084-2.

Reference Type RESULT
PMID: 14625816 (View on PubMed)

Cooper GS, Bynum ML, Somers EC. Recent insights in the epidemiology of autoimmune diseases: improved prevalence estimates and understanding of clustering of diseases. J Autoimmun. 2009 Nov-Dec;33(3-4):197-207. doi: 10.1016/j.jaut.2009.09.008. Epub 2009 Oct 9.

Reference Type RESULT
PMID: 19819109 (View on PubMed)

Clowse ME, Chakravarty E, Costenbader KH, Chambers C, Michaud K. Effects of infertility, pregnancy loss, and patient concerns on family size of women with rheumatoid arthritis and systemic lupus erythematosus. Arthritis Care Res (Hoboken). 2012 May;64(5):668-74. doi: 10.1002/acr.21593.

Reference Type RESULT
PMID: 22344961 (View on PubMed)

Padyukov L, Silva C, Stolt P, Alfredsson L, Klareskog L. A gene-environment interaction between smoking and shared epitope genes in HLA-DR provides a high risk of seropositive rheumatoid arthritis. Arthritis Rheum. 2004 Oct;50(10):3085-92. doi: 10.1002/art.20553.

Reference Type RESULT
PMID: 15476204 (View on PubMed)

Reckner Olsson A, Skogh T, Wingren G. Comorbidity and lifestyle, reproductive factors, and environmental exposures associated with rheumatoid arthritis. Ann Rheum Dis. 2001 Oct;60(10):934-9. doi: 10.1136/ard.60.10.934.

Reference Type RESULT
PMID: 11557649 (View on PubMed)

Other Identifiers

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AssiutU9

Identifier Type: -

Identifier Source: org_study_id

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