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IRCT20180922041089N2 IRCT 2019-02-06 Tehran University of Medical Sciences The Study of Vitamin D Supplement-aid in the treatment of Helicobacter Pylori eradication The Study of Vitamin D supplementation`s effect in the treatment of Helicobacter pylori eradication in patients with dyspepsia 2018-10-23 anticipated 120 Complete https://irct.ir/trial/34027 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Other design features: -Sampling method of this study is simple random sampling, so that the selected units have equal chance to be selected. Select either through the lottery or through the use of random numbers table. We will use the lottery method so that we will have two boxes for our execution, and will be used in two colors. The green color for the intervention group and the orange color for the control group are considered. 30 green paper, 30 orange paper for women in a box and 30 green paper, 30 orange paper for men in another box. The doctor gives a sheet to each patient that has criteria for entry provided there is no exit criteria. The patient is referred for further investigation to a questionnaire who is not known about the presence of the patient in the control group or intervention. after the patient is confirmed by the other criteria on the basis of other criteria, is confirmed in terms of the presence of symptoms. For each patient, demographic information and MNA questionnaire are completed. The height and weight of individuals are also measured.The height of the people is measured in the form of standing, without shoes and with a wall hanging seka in cm.The weight of people with a minimum of clothes and without shoes and heavy accessories such as cell phones and bags, is measured with a scalable scale in kilograms and a precision of 500 grams.And finally referred to the doctor for a free visit.At the start of the study each patient is given a vitamin D supplement (Zahravi Company) on a weekly basis of 50,000 units and placebo is given to control group for 12 weeks (3 months).Six weeks after the start of the project, the patients were re-examined to receive a 5-day antibiotic regimen of Anti-Helicobacter pylori (PPI and amoxicillin and tinidazole and levofloxacin). At the same time, the intervention group are evaluated about the toxicity of serum vitamin D level and patients with serum vitamin D level above 100 are excluded from the study. Patients who do not follow this diet for any reason (antibiotic complications, intolerance of the drug ...) are excluded.After 3 months from oral administration of vitamin D or about 6 weeks after the completion of the anti-hereditary bacterial diet in patients, , each of the two groups is subjected to the challenge of helicobacter pylori eradication through a fecal hollybucher pylori test (UBT Urea Breath Test). Also, the clinical symptoms of patients are recorded in each of the two groups and due to these symptoms, they are interviewed and examined, Randomization description: A random allocation method will be used. There are 30 green cards (interventions) and 30 orange cards (controls) inside white envelopes for women and the same number for men and placed inside two separate lottery boxes and eligible for each patient randomly and with Pay attention to the gender of a card, Blinding description: To eliminate the bias caused by the patient's or doctor's knowledge of the type of treatment received and its possible effect on the outcome of the study, the study is done in two blind ways. Given that the vitamin D and placebo tablets are placed in the same full capsule. The patient and the assessing doctor are not aware of the type of medication received. 3 Dyspepsia due to Helicobacterpylori. Intervention 1: The intervention group includes people 18 years old and older who receive pills of Vitamin D with a dose of 50000 for 3 months.This drug should be taken weekly. Intervention 2: The control group includes those 18 years old and older who receive placebo. 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 a publishing program for study, but there is currently no decision to publish.
public Abolfazl Zendehdel
Abuzar St, Ziaian Hospital, Tehran Town
Tehran Iran (Islamic Republic of) 1366736511 +98 21 5517 6031 Azendedel@sina.tums.ac.ir Tehran University of Medical Sciences scientific Abolfazl Zendehdel
Abuzar St,Ziaeian Hospital,Tehran Town
Tehran Iran (Islamic Republic of) 1366736511 +98 21 5517 6031 azendedel@sina.tums.ac.ir Tehran University of Medical Sciences Iran (Islamic Republic of) Age over 18 years A test of the fecal antigen of the Helicobacter pylori or Rapid urease test (RUT) is positive All patients with functional dyspepsia of the pseudo-ulcer type who did not respond to (or recurring) acid reflux therapy, or the presence or history of gastric or duodenal peptic ulcer in a patient or first-degree relatives of patients with gastric cancer Informed consent Form 18 years no limit Both The history of epilepsy History of chronic diseases (CHB, CKD, COPD, recurrent CVA or dementia, liver cirrhosis) Patients own cancers Severe psychiatric illnesses such as schizophrenia, major depression, bipolar disorders History of antibiotic use in the last 6 weeks Patients with dyspepsia with a predominant symptom of reflux Drug, alcohol and cigarettes History of gastric surgeries, IBD, diabetes, pathological weight loss (weight loss over 10% of body weight over the past 6 months) Anemia (Hemoglobin in men under 14 in males under 11 and in menopausal women under 12 (1)) Diabetes (if FBS is greater than or equal to 126 or HbA1c greater than or equal to 6.5%) corticosteroids use in the last 3 months Use of vitamin D supplements with therapeutic doses during the last 3 months or during the study Participate in another research project over the past 3 months Pregnancy or breastfeeding History of H pylori infection treatment in the past History of kidney stones Participants' unwillingness to take medication or placebo History of any allergy or side effects BMI greater than 40 K30 Functional dyspepsia Treatment - Drugs Treatment - Drugs The intervention group includes people 18 years old and older who receive pills of Vitamin D with a dose of 50000 for 3 months.This drug should be taken weekly. The control group includes those 18 years old and older who receive placebo. H-pylori Infection. Timepoint: At the beginning of the study before the intervention and 4 months after taking oral vitamin D. Method of measurement: Stool-Antigen test Or RUT. Bloating. Timepoint: At the beginning of the study and after 4 months. Method of measurement: Questionnaire and self-declaration. Nausea and vomiting. Timepoint: At the beginning of the study and after 4 months. Method of measurement: Questionnaire and self-declaration. Abdominal pain. Timepoint: At the beginning of the study and after 4 months. Method of measurement: Questionnaire and self-declaration. Tehran University of Medical Sciences Approved 2018-08-25 National Ethics Committee for Biomedical Research Ziaeian Hospital,Abuzar Street,Tehran Town Tehran Tehran Iran (Islamic Republic of)