Evaluation of the Effect of Folic Acid Supplementation on the Presentation of Nuclear Abnormalities Associated With Cytogenotoxic Damage Induced by Chronic Drug Use.
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 45
- 试验地点
- 1
- 主要终点
- Nuclear buds
研究概览
简要总结
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
详细描述
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.
- Determine the presence of micronuclei and other nuclear abnormalities in baseline samples from the group of chronic drug users and the healthy reference group.
- 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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
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.
干预措施: Folic Acid 5 MG (Drug)
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.
干预措施: Folic Acid 5 MG (Drug)
结局指标
主要结局
Nuclear buds
时间窗: 1 month
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.
Condensed chromatin
时间窗: 1 month
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.
Karyorrhexis
时间窗: 1 month
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
Karyolysis
时间窗: 1 month
Frequency of karyolysis will be assessed in oral mucosa smears for every 2000 cells under fluorescent microscopy. Karyolysis: cells that have lost their nucleus.
Micronucleated cells in 2000 cells
时间窗: 1 month
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.
Binucleated cells
时间窗: 1 month
Frequency of binucleated cells will be assessed in oral mucosa smears for every 2000 cells under fluorescent microscopy, a binucleated cell has two nuclei.
Pycnotic nucleus
时间窗: 1 month
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
次要结局
未报告次要终点
研究者
MARIA GUADALUPE SANCHEZ PARADA
Associate professor
Centro Universitario de Tonalá