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IRCT20090901002394N48 IRCT 2023-07-03 Iran University of Medical Sciences Folic Acid and Vitamin B12 in Diabetes Effect of Folic Acid and Vitamin B12 Supplementation on Cognitive Function in Patients with Type 2 Diabetes 2023-07-25 anticipated 76 Complete https://irct.ir/trial/70894 interventional Randomization: Randomized, Blinding: Triple blinded, Placebo: Used, Assignment: Parallel, Purpose: Supportive, Randomization description: In order to randomize the samples, first, a list of 78 items is generated by the software available on the internet into two groups of 38 items labeled as A or B. This list is provided to the researcher, and the eligible participants are allocated to either group A or B. The manufacturer of the placebo is asked to put one of the labels A or B on the drug and the other on the placebo by throwing a coin and keep this confidential until the end of the data analysis. Therefore the drugs are indicated with one of the letters A or B, and the placebos by the other letter. According to the randomization table, the researcher will distribute the drug and placebo according to the order of reference of the samples from packages A or B. So this study will be a three-blind study in which the patient, the researcher, and the analyst will not be aware of the type of packages received by the samples until the end of the data analysis, Blinding description: This research is a triple-blind clinical trial study in which participants, researchers, and data analysts will not know the type of intervention (placebo and synbiotic) received by the participants during the study. 3 Type 2 diabetes. Intervention 1: Intervention group: In this group, 38 people with a history of type 2 diabetes for over ten years take 1000 microgram/day B12 and 400 microgram/day folic acid for 12 weeks. Intervention 2: Control group: In this group, there are 38 people receiving placebos who take capsules completely similar to the original supplements for 12 weeks. The manufactured placebo for B12 and folic acid includes starch, which is completely similar to vitamin tablets in terms of appearance, color, smell, size, and packaging. 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 Respecting participant's privacy
public Fatemeh Mehdipoor
Iran University of Medical Sciences, Faculty of Health, Hemat Highway, next to Milad Tower, Tehran
Tehran Iran (Islamic Republic of) 1449614535 +98 21 8670 4805 fm.mhdp@gmail.com Iran University of Medical Sciences scientific Shima Jazayeri
Iran University of Medical Sciences, Faculty of Health, Hemat Highway, next to Milad Tower, Tehran
Tehran Iran (Islamic Republic of) 1449614535 +98 21 8670 4805 sh_jazayeri@tums.ac.ir Iran University of Medical Sciences Iran (Islamic Republic of) Diagnosis of diabetes by a specialist and based on the laboratory results for HA1C and 2HPG At least ten years of history of diabetes Stable blood glucose level defined by HbA1C< 8.5% Taking Metformin Age between 40 to 65 years old Willing and able to participate in the study until the end Educated enough to answer the tests 40 years 65 years Both Visual and hearing problems Taking medications effective on CNS Any uncontrolled disease based on the participant's biography including malabsorption, stroke, TIA, psychoses, peripheral neuropathy, losing consciousness, high anxiety, clinical depression, mania, dementia, Parkinson, Huntington, schizophrenia, or other chronic illnesses such as liver failure, thyroid diseases, advanced kidney complications, cancer, etc. Smoking cigarettes and taking other abusive drugs Any change in the patient's medicine or its dosage during the last 3 months before the trial Taking folate or other supplementations that interfere with the intervention since the last 2 months before the start of trial Pregnancy or breastfeeding or the intention to get pregnant Any acute illnesses a month prior to the trial E11.4 Type 2 diabetes mellitus with neurological complications Treatment - Other Placebo Intervention group: In this group, 38 people with a history of type 2 diabetes for over ten years take 1000 microgram/day B12 and 400 microgram/day folic acid for 12 weeks. Control group: In this group, there are 38 people receiving placebos who take capsules completely similar to the original supplements for 12 weeks. The manufactured placebo for B12 and folic acid includes starch, which is completely similar to vitamin tablets in terms of appearance, color, smell, size, and packaging. Serum HCY. Timepoint: At the beginning of the study (before intervention), after 12 weeks of taking folate and B12 supplements. Method of measurement: Laboratory test. Cognition. Timepoint: At the beginning of the study (before intervention), after 12 weeks of taking folate and B12 supplements. Method of measurement: MoCA test. CRP. Timepoint: At the beginning of the study (before intervention), after 12 weeks of taking folate and B12 supplements. Method of measurement: Laboratory test. Depression. Timepoint: Beginning and end of intervention. Method of measurement: Beck questionnaire. Iran University of Medical Sciences Approved 2023-06-18 Ethics committee, Iran University of Medical Sciences Iran University of Medical Sciences, near Milad Hospital, between the intersection of Sheikh Fazlollah Nouri and Shahid Chamran, Shahid Hemmat Highway Tehran Tehran Iran (Islamic Republic of)