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IRCT20210503051166N2 IRCT 2023-02-01 Mashhad University of Medical Sciences The effect of administration time of oral iron preparations on hemoglobin response The evaluation of the effect of administration time of oral Iron preparations on hemoglobin response in patients with Iron deficiency anemia 2023-04-21 anticipated 196 Complete https://irct.ir/trial/68067 interventional Randomization: Randomized, Blinding: Triple blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: A replacement block using the site https://www.sealedenvelope.com with the explanation that each block has 4 and 6 members and the shape of the blocks can be as follows: [ABAB], [ABBA, [AABB], [BBAA], [BABA][BAAB] Code A corresponds to the intervention group and code B corresponds to the control group. The aforementioned site randomly selects nineteen blocks from four blocks and twenty blocks from six blocks. So, finally 196 patients are included in the study, Blinding description: Triple Blinded The patients of the control and intervention groups are randomly divided into two groups based on the codes that were designed by the random block method. These codes are designed by another person who is not aware of the study and are provided to the participants using closed letters. The researcher, patients, physicians responsible for the patients and the person who is responsible for statistical analysis do not know about the codes related to the control and intervention groups until the end of the study. 3 Iron deficiency anemia. Intervention 1: Intervention group: In the intervention group, Iron tablets made by abidi company (Ferofort duodenal) which included 80 mg elemental iron are prescribed in the morning at 10 o'clock and placebo tablets are prescribed in the evening at 6 o'clock. Patients use these pills every day for a month. Hemoglobin level testing is done for patients before the start of the study and after one month. Intervention 2: Control group: In the intervention group, placebo tablets are prescribed in the morning at 10 o'clock and Iron tablets made by abidi company (Ferofort) which included 80 mg elemental iron are prescribed in the evening at 6 o'clock. Patients use these pills every day for a month. Hemoglobin level testing is done for patients before the start of the study and after one month. No - There is not a plan to make this available Justification or reason for not sharing IPD is All participants' information will be kept strictly confidential during and after the study
public Omid Arasteh
Azadi Square, University Campus, Faculty of Pharmacy
Mashhad Iran (Islamic Republic of) 9177948954 +98 51 3180 1760 Arasteho@mums.ac.ir Mashhad University of Medical Sciences scientific Omid Arasteh
Azadi Square, University Campus, Faculty of Pharmacy
Mashhad Iran (Islamic Republic of) 9177948954 +98 51 3180 1760 Arasteho@mums.ac.ir Mashhad University of Medical Sciences Iran (Islamic Republic of) Iran (Islamic Republic of) Patients with iron deficiency anemia based on iron profile study such as serum iron, ferritin, and transferrin saturation percent Hemoglobin level less than 11 mg/dl Not suffering from chronic liver disease (normal bilirubin, LFT<2 times normal), or other chronic inflammatory diseases based on initial evaluation Not suffering from active malignancy based on initial evaluation Not suffering from active infection based on initial evaluation Not suffering from any of the malabsorption syndromes based on the initial evaluation Patients with cardiovascular risk factors 18 years 75 years Both Suffering from any chronic kidney disease, liver disease, all types of cancer, infections and autoimmune diseases The patient's lack of consent to participate in the plan Having dyspepsia and intolerance to iron food products High CRP levels at study entry D50 Iron deficiency anemia Treatment - Drugs Treatment - Drugs Intervention group: In the intervention group, Iron tablets made by abidi company (Ferofort duodenal) which included 80 mg elemental iron are prescribed in the morning at 10 o'clock and placebo tablets are prescribed in the evening at 6 o'clock. Patients use these pills every day for a month. Hemoglobin level testing is done for patients before the start of the study and after one month. Control group: In the intervention group, placebo tablets are prescribed in the morning at 10 o'clock and Iron tablets made by abidi company (Ferofort) which included 80 mg elemental iron are prescribed in the evening at 6 o'clock. Patients use these pills every day for a month. Hemoglobin level testing is done for patients before the start of the study and after one month. Increase in hemoglobin level. Timepoint: before intervention and 4 weeks after intervention. Method of measurement: Hemoglobin concentration in complete blood count test. Mashhad University of Medical Sciences Approved 2022-12-31 Ethics committee of Mashhad University of Medical Sciences No. 16, 21th Edalat avenue., Ahmadabad blvd Mashhad Razavi Khorasan Iran (Islamic Republic of)