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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

45 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-02-01

Study Completion Date

2023-08-01

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Therapeutic Effect of Folic Acid in Healing of Oral Ulcers

NCT04989049

Oral Ulcer

UNKNOWN EARLY_PHASE1

Bioavailability Study of Folic Acid in Healthy Women

NCT00709267

Healthy Pharmacokinetics

COMPLETED PHASE1

Effect of Folic Acid and Vitamin B12 Supplementation in Subjects With Type 2 Diabetes

NCT02786823

Diabetes Mellitus, Type 2

COMPLETED PHASE2/PHASE3

Folate Absorption Across the Large Intestine

NCT00941174

Healthy

COMPLETED PHASE1

The Effect of Folic Acid Administration in the Progression of Microalbuminuria

NCT00737126

Diabetic Nephropathies Hyperhomocysteinemia

COMPLETED NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Objectives.

* General Objective. To determine the effect of folic acid supplementation on the presentation of nuclear abnormalities associated with cytogenotoxic damage in healthy subjects and chronic drug users.
* Specific objectives.

1. Determine the presence of micronuclei and other nuclear abnormalities in baseline samples from the group of chronic drug users and the healthy reference group.
2. To compare baseline cytogenotoxic damage determinations with subsequent damage determinations, at 15 and 30 days, in chronic drug users supplemented with folic acid.

Material and methods.
* Study design. Quasi-experimental study of pretest-posttest design with non-equivalent control group in subjects with substance abuse and healthy subjects. The intervention will consist of the administration of 15 mg of folic acid divided into 3 doses per day. Duplicate oral mucosa samples will be taken from each participant to determine the frequency of micronuclei (MN), nuclear sprouting (NBUD), binucleated cells (BN), condensed chromatin (CC), karyorrhexis (CR), pyknosis (PIC) and karyolysis. (CL) in different temporary events: pre-treatment, at 15 days and 30 days.

This project will be carried out in inmates of a rehabilitation center in El Salto, Jalisco, Mexico, in participants over 18 years of age, chronic drug users (More than 6 months of consumption). The foregoing under prior informed consent, in a convenience sample of 45 chronic drug users, as well as an equivalent sample of 45 healthy individuals without such a history.

* Sample size At convenience. 45 chronic drug users, inmates of a rehabilitation center in Salto, Jalisco, as well as 45 healthy individuals with no history of drug use will be considered.
* Data collection techniques and instruments. It will be done by taking oral cytology, as well as by means of a confidential questionnaire, in the questionnaire sociodemographic data will be collected such as: sex, age, profession, schooling, as well as information related to the consumption of psychoactive substances such as: tobacco, marijuana, alcohol, inhalants, cocaine and methamphetamines, significant pathological and non-pathological personal history. In addition to data referring to the consumption of a nutritional 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 severe active periodontal disease. Exposure to fertilizers, radiation, heavy metals, as well as place of residence to rule out that they live in areas with high levels of air pollution (Tlaquepaque, Miravalle, Las Juntas and Las Pintas). Likewise, a physical examination of the oral cavity will be carried out by a dentist. All of the above in order to identify pathologies that have been shown to generate bias in the results obtained.

Folic acid will be used in the intervention stage in 5 mg tablets, box with 20 tablets, under the trade name Colicid from Bruluagsa.

---Cyto-genotoxic analysis by micronuclei in exfoliated cells of oral mucosa. The cytogenotoxic effect generated by the drugs will be evaluated, as well as the effect conferred to the administration of folic acid on the presentation of nuclear abnormalities associated with cytogenotoxic damage in chronic drug users.

In supplemented and non-supplemented individuals, through the oral mucosa cell micronucleus bioassay, duplicate samples will be obtained from each individual, spread on slides and stained with specific staining of nucleic acids (NA), frequency of micronuclei (MN), nuclear buds (NBUD), binucleated cells (BN), condensed chromatin (CC), karyorrhexis (CR), pyknosis (PIC) and karyolysis (CL).

---Data management and analysis The analysis of the data will be carried out in the GraphPad 9.2.0 program for Windows. For the continuous quantitative variables, the data will be presented with measures of central tendency and dispersion: mean and standard deviation. For the ordinal quantitative variables, they will be presented in frequencies and percentages, for the comparison of frequencies between sexes and age groups with the Fisher X2 test considering a p \< 0.05.

The statistical analysis to find differences between the groups will be carried out by means of the T test and for the ordinal variables it will be calculated by means of Chi2.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Drug Abuse Genotoxicity

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

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.

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Participants

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Basal

Samples will be taken to participants.

Group Type NO_INTERVENTION

No interventions assigned to this group

15 days folate suplementation

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.

Group Type EXPERIMENTAL

Folic Acid 5 MG

Intervention Type 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.

30 days folate suplementatio

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.

Group Type EXPERIMENTAL

Folic Acid 5 MG

Intervention Type 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.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Folic Acid 5 MG

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.

Intervention Type DRUG

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

folic acid 5mg cilocid bruluagsa

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes