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IRCT20100524004010N22 IRCT 2018-02-01 Shahid Beheshti University of Medical Sciences The effect of vitamin D supplementation in patients with ulcerative colitis Study of the effect of vitamin D supplementation on serum vitamin D concentration, quality of life, disease activity index, and some of inflammatory and oxidative factors in patients with ulcerative colitis with vitamin D deficiency 2017-04-19 anticipated 50 Complete https://irct.ir/trial/4194 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Supportive, Randomization description: In this research patients will be gathered by Convenience Sampling and they will be divided in to two groups by Blocked Randomization, Blinding description: To make this research double blind, before starting the study a person out of study coded the drug boxes to A, B and C. Box A and B contain vitamin D pearls with the dose of 1000 IU and box C contains pelacebo pearls. All patients receive box A but according to which group they take place, high or low dose vitamin D supplement will receive box B or C respectively. Thus patients in high dose supplementation group receive box A and B and will use one pearl from box A and one from box B daily which provide 2000 IU vitamin D per day. While patients in low dose vitamin D group receive box A and c, will use one pearl from box A and one from box C which provide 1000 IU vitamin d daily. N/A ulcerative colitis. Intervention 1: vitamin D supplement for 12 weeks 2 pearl contain 1000 IU daily. Intervention 2: One vitamin D supplement 1000 IU daily and one pelacebo for 12 weeks. 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 There is no more information.
public Azita Hekmatdoost
Shahrak Qarb
Tehran Iran (Islamic Republic of) 1981619573 +98 21 2237 6480 A_hekmat2000@yahoo.com Shahid Beheshti Nutrition Faculty scientific Azita Hekmatdoost
No.7 Hafezi St., Farahzadi Blvd.,. Shahrak Qarb
Tehran Iran (Islamic Republic of) 1981619573 +98 21 2237 6480 A_hekmat2000@yahoo.com Shahid Beheshti Nutrition Faculty Iran (Islamic Republic of) Cases with Ulcerative colitis Active mild to moderate disease severity No evident affliction with other intestinal diseases or disorders, inflammatory diseases and infectious diseases No history of taking supplements such as vitamin D multivitamin-mineral, omega-3, polyphenolic and antioxidants Not taking anti-coagulation drugs such as Heparin and Warfarin or NSAIDs (Non steroidal anti-inflammatory drugs), antihistamines and calcium channel antagonists such as Nifedipine within the past month Patients with vitamin d defficiency (less than 30 nano gram per mili liter) Body mass index (BMI) over than 18.5 and less than 30 kg/m2 Tendency to participate in this research No change in type & dose of drug usage during last month 18 years 80 years Both Pregnancy or lactation in women or use of oral contraceptive drugs The patient Unwillingness to continue participation in this research Drug type and dosage change during intervention K51.9 Ulcerative colitis, unspecified Treatment - Drugs Treatment - Drugs vitamin D supplement for 12 weeks 2 pearl contain 1000 IU daily One vitamin D supplement 1000 IU daily and one pelacebo for 12 weeks Simple Clinical Colitis Activity Index. Timepoint: At the beginning and at the end of the study. Method of measurement: Simple Clinical Colitis Activity Index Questionnaire (SCCAIQ). Quality of life. Timepoint: At the beginning and at the end of the study. Method of measurement: Inflammatory Bowel Disease Questionnaire -9 (IBDQ-9). TNF-α. Timepoint: At the beginning and at the end of the study. Method of measurement: ELISA. Hs-CRP. Timepoint: At the beginning and at the end of the study. Method of measurement: ELISA. Serum TOC. Timepoint: At the beginning and at the end of the study. Method of measurement: kit. Serum TAC. Timepoint: At the beginning and at the end of the study. Method of measurement: kit. Carbohydrate intake. Timepoint: At the beginning and at the end of the study. Method of measurement: 24h recall questionnaire. Weight. Timepoint: At the beginning and at the end of the study. Method of measurement: Scale. Waist circumference. Timepoint: At the beginning and at the end of the study. Method of measurement: Metre. Hip circumference. Timepoint: At the beginning and at the end of the study. Method of measurement: Metre. Body Mass Index. Timepoint: At the beginning and at the end of the study. Method of measurement: Calculating. Total energy intake. Timepoint: At the beginning and at the end of the study. Method of measurement: 24h recall questionnaire. Protein intake. Timepoint: At the beginning and at the end of the study. Method of measurement: 24h recall questionnaire. Total fat intake. Timepoint: At the beginning and at the end of the study. Method of measurement: 24h recall questionnaire. PUFA fatty acid intake (omega 3). Timepoint: At the beginning and at the end of the study. Method of measurement: 24h recall questionnaire. Cholesterol intake. Timepoint: At the beginning and at the end of the study. Method of measurement: 24h recall questionnaire. Fiber intake. Timepoint: At the beginning and at the end of the study. Method of measurement: 24h recall questionnaire. SFA fatty acid intake. Timepoint: At the beginning and at the end of the study. Method of measurement: 24h recall questionnaire. MUFA fatty acid intake. Timepoint: At the beginning and at the end of the study. Method of measurement: 24h recall questionnaire. PUFA fatty acid intake (omega 6). Timepoint: At the beginning and at the end of the study. Method of measurement: 24h recall questionnaire. Vitamin E intake. Timepoint: At the beginning and at the end of the study. Method of measurement: 24h recall questionnaire. VitaminC intake. Timepoint: At the beginning and at the end of the study. Method of measurement: 24h recall questionnaire. Zinc intake. Timepoint: At the beginning and at the end of the study. Method of measurement: 24h recall questionnaire. Selenium intake. Timepoint: At the beginning and at the end of the study. Method of measurement: 24h recall questionnaire. Folate intake. Timepoint: At the beginning and at the end of the study. Method of measurement: 24h recall questionnaire. Carotenoids intake. Timepoint: At the beginning and at the end of the study. Method of measurement: 24h recall questionnaire. Vitamin A intake. Timepoint: At the beginning and at the end of the study. Method of measurement: 24h recall questionnaire. Shahid Beheshti University of Medical Sciences Approved 2017-03-06 Ethics Committee of Shahid Beheshti University of Medical Sciences West Arghavan Street, farahzadi Bulevard, Shahrak Qods Tehran Tehran Iran (Islamic Republic of) Approved 2010-09-23 Ethics Committee of National Nutrition and Food Technology Research Institute No 7, West Hafezi Street, Farahzadi Boulevard, Shakrak Gharb Tehran Tehran Iran (Islamic Republic of)