Drug Abuse Clinical Trial
Official title:
Evaluation of the Effect of Folic Acid Supplementation on the Presentation of Nuclear Abnormalities Associated With Cytogenotoxic Damage Induced by Chronic Drug Use.
Background: Multiple studies have pointed to the harmful potential of licit and illicit drugs. as agents associated with neoplastic processes and other non-communicable diseases, for which reason It has become a problem of global size. Objective: The central objective is to determine the cytogenotoxic damage in the oral mucosa of people with chronic drug use, as well as establishing the therapeutic effect of acid administration folic on said damage. Methodology: Quasi-experimental study, pretest-posttest design with no control group. equivalent, in subjects with substance abuse and healthy subjects. The intervention will consist of administration of 15 mg of folic acid divided into 3 doses per day. Mucosal samples will be taken orally in duplicate to each participant to determine the frequency of micronuclei (MN), bursts cells (NBUD), binucleated cells (BN), condensed chromatin (CC), karyorrhexis (CR), pyknosis (PIC) and caryolysis (CL) at different time events: pre-treatment, 15 days and 30 days. So as a survey to determine consumption patterns of psychoactives, sociodemographic data, dietary and exposure to known cytogenotoxic agents. Resources and infrastructure: The study will be carried out in the pharmacology laboratory of the Center University of Tonalá, who will make their equipment and reagents available. Group experience: The research group has over a decade of experience in the development of projects related to mutagenesis and cyto-genotoxic agents. Development time: The project will be developed from February 2023 to August of 2023
Status | Not yet recruiting |
Enrollment | 45 |
Est. completion date | August 1, 2023 |
Est. primary completion date | May 1, 2023 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion criteria: - Being 18 years of age or older - Having used legal and illegal drugs. - Men or women without diseases Exclusion criteria: - People who at the moment of the study or 3 months before: - Have consumed any dietary supplement or vitamin such as folates, B12, - C, E, A, lutein or melatonin, or some other antioxidant, medications for - pharmacological treatment of chronic disease and/or periodontal disease - severe active. - That they were exposed to fertilizers, radiation, metals heavy or who live in areas with high levels of air pollution (Tlaquepaque, Miravalle, Las Juntas and Las Pintas). - Individuals who after have been informed of the advantages and risks of participating in the study, decide not to be part of this study. |
Country | Name | City | State |
---|---|---|---|
Mexico | CUTONALA | Tonala | Jalisco |
Lead Sponsor | Collaborator |
---|---|
Centro Universitario de Tonalá |
Mexico,
Thomas P, Holland N, Bolognesi C, Kirsch-Volders M, Bonassi S, Zeiger E, Knasmueller S, Fenech M. Buccal micronucleus cytome assay. Nat Protoc. 2009;4(6):825-37. doi: 10.1038/nprot.2009.53. Epub 2009 May 7. — View Citation
Torres-Bugarin O, Zavala-Cerna MG, Nava A, Flores-Garcia A, Ramos-Ibarra ML. Potential uses, limitations, and basic procedures of micronuclei and nuclear abnormalities in buccal cells. Dis Markers. 2014;2014:956835. doi: 10.1155/2014/956835. Epub 2014 Feb 4. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Micronucleated cells in 2000 cells | Frequency of micronucleated cells will be assessed in oral mucosa smears for every 2000 cells under fluorescent microscopy, a micronucleated cell has a main nucleus and a smaller one no larger than a third the size of the main nucleus. | 1 month | |
Primary | Binucleated cells | Frequency of binucleated cells will be assessed in oral mucosa smears for every 2000 cells under fluorescent microscopy, a binucleated cell has two nuclei. | 1 month | |
Primary | Karyorrhexis | Frequency of karyorrhexis cells will be assessed in oral mucosa smears for every 2000 cells under fluorescent microscopy. Karyorrhexis: cells that appear to have an striated or fragmented nucleus | 1 month | |
Primary | Karyolysis | Frequency of karyolysis will be assessed in oral mucosa smears for every 2000 cells under fluorescent microscopy. Karyolysis: cells that have lost their nucleus. | 1 month | |
Primary | Pycnotic nucleus | Frequency of pycnotic cells will be assessed in oral mucosa smears for every 2000 cells under fluorescent microscopy. Pycnotic cells: appear to have a very dense, brighter, and smaller nucleus, approximately one third of the original | 1 month | |
Primary | Nuclear buds | Frequency of nuclear budding will be assessed in oral mucosa smears for every 2000 cells under fluorescent microscopy. Nuclear bud: a small portion of the genetic material connected through a nucleoplasmic bridge to a main nucleus. | 1 month | |
Primary | Condensed chromatin | Frequency of condensed chromatin will be assessed in oral mucosa smears for every 2000 cells under fluorescent microscopy. Condensed chromatin: where genetic material can be seen in the nuclei. | 1 month |
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