Effect of Folic Acid on the Presentation of Nuclear Abnormalities in People With a History Drug Abuse

NCT05712044 | Unknown

• 1 other identifier: F-2022-004
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Drug Abuse; Genotoxicity

Outcome Measures

Primary Outcomes (7)

• 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

• 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

• 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

• 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

• 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

• 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

• 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

Study Arms (3)

Basal

NO INTERVENTION

Samples will be taken to participants.

15 days folate suplementation

EXPERIMENTAL

5mg tablets of folic acid will be given to participants every 8 hours for a period of 15 days, then samples are to be taken in duplicate for each individual.

Drug: Folic Acid 5 MG

30 days folate suplementatio

EXPERIMENTAL

5mg tablets of folic acid will be given to participants every 8 hours fora a period of 30 days, then samples are to be taken in duplicate for each individual.

Drug: Folic Acid 5 MG

Interventions

Folic Acid 5 MG DRUG

Folic acid 5mg tablets will be administered orally every 8 hours then samples from buccal mucosa will be taken 15 days and 30 days after suplementation.

Also known as: folic acid 5mg cilocid bruluagsa

15 days folate suplementation; 30 days folate suplementatio

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Being 18 years of age or older
• Having used legal and illegal drugs.
• Men or women without diseases

You may not qualify if:

• 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.

Sponsors & Collaborators

• Centro Universitario de Tonalá: lead

Study Sites (1)

CUTONALA

Tonalá, Jalisco, 45400, Mexico

Location

Related Publications (2)

• 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.

  PMID: 19444240 BACKGROUND

• 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.

  PMID: 24778463 BACKGROUND

MeSH Terms

Conditions

Substance-Related Disorders

Interventions

Folic Acid

Condition Hierarchy (Ancestors)

Chemically-Induced Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Pterins; Pteridines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Guadalupe Sanchez, PhD

  Centro Universitario de Tonalá

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Alejandro Gomez, Bachelor

CONTACT

3319955964; alex-gomez96@hotmail.com

Francisco Rodriguez, Bachelor

CONTACT

3317055900; franciscomora1097@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate professor

Model Details: 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.

Study Record Dates

• First Submitted: January 2, 2023
• First Posted: February 3, 2023
• Study Start: February 1, 2023
• Primary Completion: May 1, 2023
• Study Completion: August 1, 2023
• Last Updated: February 3, 2023

Record last verified: 2023-01

Data Sharing

• IPD Sharing: Will not share

Locations

ME (1)