NCT03624179

Brief Summary

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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Aug 2018

Shorter than P25 for all trials

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 11, 2018

Completed
1 month until next milestone

First Posted

Study publicly available on registry

August 10, 2018

Completed
5 days until next milestone

Study Start

First participant enrolled

August 15, 2018

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 15, 2018

Completed
5 days until next milestone

Study Completion

Last participant's last visit for all outcomes

September 20, 2018

Completed
Last Updated

August 10, 2018

Status Verified

August 1, 2018

Enrollment Period

1 month

First QC Date

July 11, 2018

Last Update Submit

August 8, 2018

Conditions

Rheumatoid Arthritis

Outcome Measures

Primary Outcomes (2)

  • vitamin D level

    blood sample using ELISA kits

    one month

  • Body mass index

    weight in kg/m\^2

    one month

Secondary Outcomes (2)

  • Anti cyclic citrullnated peptide antibodies

    one month

  • Rheumatoid factor antibody

    one month

Study Arms (2)

Rheumatoid arthritis patients

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

healthy control

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

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

patients with rheumatoid arthritis

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (12)

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

    PMID: 3468952BACKGROUND

  • 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.

    PMID: 22119899BACKGROUND

  • 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.

    PMID: 4003932BACKGROUND

  • 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.

    PMID: 165046BACKGROUND

  • 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.

    PMID: 1753392BACKGROUND

  • 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.

    PMID: 15529351RESULT

  • 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.

    PMID: 2783422RESULT

  • 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.

    PMID: 14625816RESULT

  • 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.

    PMID: 19819109RESULT

  • 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.

    PMID: 22344961RESULT

  • 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.

    PMID: 15476204RESULT

  • 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.

    PMID: 11557649RESULT

MeSH Terms

Conditions

Arthritis, Rheumatoid

Condition Hierarchy (Ancestors)

ArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic DiseasesConnective Tissue DiseasesSkin and Connective Tissue DiseasesAutoimmune DiseasesImmune System Diseases

Central Study Contacts

Ebtsam M Abd El Hakeem, MIS

CONTACT

01065889869smilemostafa@gmail.com

EL Badry I Abo Elnour, MD

CONTACT

01091131611aboelnour@aun.edu.eg

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
principle investigator

Study Record Dates

First Submitted

July 11, 2018

First Posted

August 10, 2018

Study Start

August 15, 2018

Primary Completion

September 15, 2018

Study Completion

September 20, 2018

Last Updated

August 10, 2018

Record last verified: 2018-08