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IRCT20180626040248N1 IRCT 2018-09-22 Sabzevar University of Medical Sciences Effectiveness of Synbiotic and Vitamin D in Atopic Dermatitis Study of the effectiveness of Synbiotic and Vitamin D on the Severity of Atopic Dermatitis in 1 to 24 Months Old Children 1988-07-11 anticipated 80 Complete https://irct.ir/trial/32265 interventional Randomization: Randomized, Blinding: Triple blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: After checking the inclusion and excclusion critria, patients are randomly (six blocks) divided into three groups which are defined by the statistic consultant by using random allocatin software, Blinding description: The parents of patients are not known to be in the intervention or control group The examiner, who evaluates the severity of the illness, is unaware of the type of treatment that the patient received and their group. 3 Atopic Dermatitis. Intervention 1: Intervention group1: In this group, patients receive 5 drops of pedilact daily for two months in addition to routine treatments . pedilact is a synbiotic ( prebiotic + probiotic). Intervention 2: Intervention group2: In this group, patients receive 1,000 units of vitamin D per day for two month in addition to routine treatments.(1cc of drop vitamin D 1000iu). Intervention 3: Control group: In this group, patients receive routine treatments including topical corticosteroids, moisturizing agents, antihistamines, and ext. Undecided - It is not yet known if there will be a plan to make this available Justification or reason for indecision in sharing IPD is No more information
public Fatemeh Shamabadi
Tohid town
Sabzevar Iran (Islamic Republic of) 96179-56333 +98 51 4441 0325 fatemeh.shamabadi@medsab.ac.ir Sabzevar University of Medical Sciences scientific Mitra Aldaghi
Asadabadi Ave
Sabzevar Iran (Islamic Republic of) 9613873136 +98 51 4401 1600 mitra.aldaghi@medsab.ac.ir Sabzevar University of Medical Sciences Iran (Islamic Republic of) Being 1-24 month of age Absence of any other chronic disease Having used no immunosuppressive medicines, corticosteroids and antibiotics for one week prior of the study Mother's willingness 1 month 24 months Both Infectious disease Receive immunosuppressive medicines, corticosteroids and antibiotics Mother's unwillingness L20-L30 Atopic dermatitisExcl.:circumscribed neurodermatitis (L28.0)L20.0Besnier prurigoL20.8Other atopic dermatitisEczema:flexural NECinfantile (acute)(chronic)intrinsic (allergic)Neurodermatitis:atopicdiffuseL20.9Atopic dermatitis, unspecifiedL21 Treatment - Drugs Treatment - Drugs Treatment - Drugs Intervention group1: In this group, patients receive 5 drops of pedilact daily for two months in addition to routine treatments . pedilact is a synbiotic ( prebiotic + probiotic) Intervention group2: In this group, patients receive 1,000 units of vitamin D per day for two month in addition to routine treatments.(1cc of drop vitamin D 1000iu) Control group: In this group, patients receive routine treatments including topical corticosteroids, moisturizing agents, antihistamines, and ext. Score of Atopic Dermatitis according to SCORAD. Timepoint: Beginning and end of the study (week 8). Method of measurement: SCORAD (scoring of Atopic Dermatitis). Sabzevar University of Medical Sciences Approved 2018-05-28 Ethics committee of Sabzevar University of Medical Sciences Shohadaye hasteie Blvd.,Tohid Town Sabzevar Razavi Khorasan Iran (Islamic Republic of)