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IRCT20230501058037N1 IRCT 2023-06-19 Shahid Beheshti University of Medical Sciences Effect of Cinnamon and Chromium Picolinate supplementation on Hemoglobin A1c in Patients with Type 1 Diabetes. Evaluation and comparison of the effect of Cinnamon and Chromium Picolinate supplementation on Hemoglobin A1c in Patients with Type 1 Diabetes mellitus. 2022-05-21 anticipated 90 Complete https://irct.ir/trial/70040 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Due to randomization of participants of this study, we used restricted randomization in type of block randomiztion.Size of blocks were equal and consisted of six participants, two participants in cinnamon, two participants in chromium picolinate and two in control group, Blinding description: Cinnamon and Chromium Picolinate were placed in boxes that could not be distinguished by Color, Size and Shape.Researchers and Participants were blinded to the contents of the boxes. 3 Type 1 diabetes. Intervention 1: The first intervention group: 180 capsules containing 500 mg cinnamon of Synabetic brand for using 2 times per day were provided to each patient in two 90 days courses, and the patients received supplements for 180 days in total. Intervention 2: The second intervention group: 90 tablets containing 200 microgram of chromium picolinate in VITABIOTICS brand for using once daily was provided to patients in two 90 days courses and the patients received supplements for 180 days in total. Intervention 3: Control group: With no intervention or placebo consumption and just with their insulin regime, control group were followed and evaluated the same as interventional groups in two 90 days courses. Yes - There is a plan to make this available What will be shared: Data can potentially be shared after de-identifying individuals When: The access period starts 6 months after the results are published To whom: The data will be available to researchers working in academic and scientific institutions and people working in industry Conditions: Unlimited Where to obtain: Shirin Ghane Fard. 09123549408. Sh.ghanefard@sbmu.ac.ir. How to obtain: Unlimited Comments:
public Shirin Ghane Fard
Mofid Children's Hospital, Dr Shariati street
Tehran Iran (Islamic Republic of) 1546815514 +98 21 2222 7021 Sh.ghanefard@sbmu.ac.ir Shahid Beheshti University of Medical Sciences scientific Shadab Salehpour
Loghman-e Hakim Hospital, Kamali street, Karegar Ave.
Tehran Iran (Islamic Republic of) 1989934148 +98 21 2271 8000 shadab.salehpour@gmail.com Shahid Beheshti University of Medical Sciences Iran (Islamic Republic of) Type 1 diabetes has been diagnosed for 18 months before entering the study Patients must be less than 18 years old when entering the study Refer to Mofid hospital clinic for routine care Patients have not taken medicinal plants or other supplements in the last 8 weeks Do not be allergic to supplements no limit 18 years Both Patients do not have a history of hospitalization for medical or psychiatric reasons in the last 12 months It is not possible to access by phone Pregnancy or breastfeeding Hemoglobinopathy Acute infection (pneumonia, urinary tract infection, otitis) E10.9 Type 1 diabetes mellitus without complications Treatment - Drugs Treatment - Drugs Treatment - Drugs The first intervention group: 180 capsules containing 500 mg cinnamon of Synabetic brand for using 2 times per day were provided to each patient in two 90 days courses, and the patients received supplements for 180 days in total. The second intervention group: 90 tablets containing 200 microgram of chromium picolinate in VITABIOTICS brand for using once daily was provided to patients in two 90 days courses and the patients received supplements for 180 days in total. Control group: With no intervention or placebo consumption and just with their insulin regime, control group were followed and evaluated the same as interventional groups in two 90 days courses. Age Of The Patient. Timepoint: At The Beginning Of The Study. Method of measurement: Questionnaire-Clinical File. Gender Of The Patient. Timepoint: At The Beginning Of The Study. Method of measurement: Questionnaire-Clinical File. Height Of The Patient. Timepoint: At The Beginning Of The Study. Method of measurement: Meter. Patient Weight. Timepoint: At The Beginning Of The Study. Method of measurement: Scales. Body Mass Index. Timepoint: At The Beginning Of The Study. Method of measurement: Questionnaire-Clinical File. Duration of diagnosis. Timepoint: At The Beginning Of The Study. Method of measurement: Questionnaire-Clinical File. The Stage Of Maturation Of The Patient. Timepoint: At The Beginning Of The Study. Method of measurement: Questionnaire-Clinical File. Fasting Blood Sugar. Timepoint: At the beginning of the study, day 90 and day 180 in patients. Method of measurement: Paraclinic – Laboratory. Hemoglobin A1C. Timepoint: At the beginning of the study, day 90 and day 180 in patients. Method of measurement: Paraclinic – Laboratory. Triglyceride. Timepoint: At the beginning of the study, day 90 and day 180 in patients. Method of measurement: Paraclinic – Laboratory. TYG index. Timepoint: At the beginning of the study, day 90 and day 180 in patients. Method of measurement: Paraclinic – Laboratory. Insulin Carbohydrate Ratio. Timepoint: At the beginning of the study, day 90 and day 180 in patients. Method of measurement: Paraclinic – Laboratory. Daily Use of Insulin. Timepoint: At the beginning of the study, day 90 and day 180 in patients. Method of measurement: Questionnaire-Clinical File. Shahid Beheshti University of Medical Sciences Approved 2021-11-22 Ethics committee of Shahid Beheshti University of Medical Sciences Shahid Beheshti University of Medical Sciences, Daneshjoo boulevard, Velenjak street. Tehran Tehran Iran (Islamic Republic of)