Clinical trial NCT03624179: Study of Some Risk Factors for Developing RA
Official title: Study of Some Risk Factors for Developing Rheumatoid Arthritis
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Rheumatoid Arthritis
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2018-08-10
Enrollment: 60
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: patients with rheumatoid arthritis

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.

Detailed description: 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

Eligibility criteria: 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

Primary outcomes:
measure: vitamin D level
timeFrame: one month
measure: Body mass index
timeFrame: one month
Secondary outcomes:
measure: Anti cyclic citrullnated peptide antibodies
timeFrame: one month
measure: Rheumatoid factor antibody
timeFrame: one month
Other outcomes:
Locations:
Study officials:
References:
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