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

The aim of this study was to evaluate the effects of supplementation with vitamin D 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.

In this research, 50 eligible patients referring to Gastroenterology Clinic of Fayaz Bakhsh Hospital were chosen purposefully and were randomly divided into two groups of receiving high dose vitamin D and low dose vitamin D. Group allocation was concealed by assigning a unique code to each participants.

In this research, Ulcerative Colitis (UC) patients will be selected from those who are referred to Gastroenterology Clinic of Fayaz Bakhsh Hospital and met the inclusion criteria. Anthropometric characteristics including weight, height, waist circumference (WC) and hip circumference (HC) will be measured and Body Mass Index (BMI) will be calculated for each patient at the baseline and also at the end of the study. Inflammatory Bowel Disease Questionnaire (IBD-Q9) and Simple Clinical Colitis Activity Index Questionnaire (SCCAI-Q) will be completed for each patient and blood samples will be collected after 12-14 hours fasting at the baseline and after the treatment. Plasma samples will be frozen for measuring inflammatory factors. According to their group, patients will receive supplementation for 12 weeks. To investigate patients diet, a 24 hour recall will be completed at the baseline and at the end of treatment. Patients will be asked not to change their diet and physical activity during the study period.

Inclusion criteria: cases with Ulcerative Colitis; active mild to moderate disease severity; no evident of 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 (Nonsteroidal anti-inflammatory drugs), antihistamines and calcium channel antagonists such as Nifedipine within the past month; patients with vitamin D deficiency (less than 30 nano gram per mili liter); Body Mass Index (BMI) more than 18.5 and less than 30 kg/m2; tendency to participate in this research; no change in drug type & dosage during last month. Exclusion criteria: pregnancy or lactation in women or usage of oral contraceptive drugs; drug type and dosage change during intervention; the patient's unwillingness to continue participation in this research .

Patients will be devided in to two groups, one group will receive high dose of vitamin D (two pearl of 1000 IU vitamin D daily) and other group will receive low dose of vitamin D (one pearl of 1000 IU vitamin D and one pearl of pelacebo daily)

At last effect of vitamin D supplementation on serum vitamin D concentration, TNF-α, interlukin 6, hs-CRP, Total AntiOxidative Capacity, Total Oxidative Capacity, quality of life and relapse of the disease will be assessed.

National Nutrition and Food Technology Research Institute

In this research patients will be gathered by Convenience Sampling and they will be divided in to two groups by Blocked Randomization.

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.